Coronary Artery DiseaseNCT06007248
Disease Characteristics of IR-CAD: a Case-control Study
An observational study of Coronary Artery Disease and Coronary Artery Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis
- What is being tested?
- Protocol-defined Examinations
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2023to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study.
Who may be able to join
- Case group (IR-CAD patients):
- 18 years of age or older, male or female.
- Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- Prior history of coronary revascularization (PCI or coronary artery bypass graft [CABG]).
- Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
- Hospitalization due to rapidly-progressive myocardial ischemia:
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- Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV) and non-invasive evidence of myocardial ischemia; and
- Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
- Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
- Evidence of inflammation:
- At least one of the indexes indicating active inflammation has ever been elevated (ESR, high-sensitivity C-reactive protein [hs-CRP], interleukin [IL]-6, tumor necrosis factor [TNF]-α, ferritin, et al); or
- Established diagnosis of systemic autoimmune disease or systemic vasculitis; or
- Receiving immunosuppressive therapy.
- Control group (AS-CAD patients):
- ≥ 45 and < 65 years of age (based on the age distribution of the patients currently enrolled in the IR-CAD cohort study), male or female.
- Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- Currently, 12±6 months after the last PCI.
- Receiving standard treatment for secondary prevention of AS-CAD after the last PCI.
- Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization.
- No evidence of rapidly-progressive myocardial ischemia, which is defined as follows:
- Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV) and non-invasive evidence of myocardial ischemia; and
- Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI.
- No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
Who cannot join
- Case group (IR-CAD patients):
- Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
- Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
- Active acute or chronic infection (human immunodeficiency virus [HIV], tuberculosis, et al).
- Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
- Vital organ failure.
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- Life expectancy < 1 year.
- Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
- In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
- Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
- Previous enrollment in this study.
- Participation in another study within 30 days.
- Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
- Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.
- Control group (AS-CAD patients):
- The same as those for the case group (IR-CAD patients).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhenyu Liu, M.D., +861069155068, pumch_lzy@163.com
Lihong Xu, B.N., +861069155068, xulihong1990@163.com
About this study
Official title: Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Case-control Study
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.
Read the detailed description
A special type of coronary artery disease (CAD) has been identified in the investigators' clinical practice, which has completely different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD). The patients often have sterile inflammatory diseases and/or clinical evidence of inflammation, whose CAD progresses rapidly, recurs frequently, and responds poorly to intensified secondary prevention of AS-CAD, especially after percutaneous coronary intervention (PCI). The investigators name this special type of CAD with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD). Currently, the overall disease characteristics of IR-CAD remain unknown.
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.
The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients were diagnosed as IR-CAD if they have 1) evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization) myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnosis of inflammatory diseases or use of immunosuppressive therapy). The comprehensive treatment for IR-CAD included: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies.
Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study. Patients will be diagnoses as AS-CAD if they 1) are ≥ 45 but < 65 years of age; 2) are receiving standard treatment for secondary prevention of AS-CAD after the last PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI) myocardial ischemia (typical symptoms and non-invasive evidence); 4) do not have angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
Patients in the IR-CAD cohort study underwent examinations after they met the inclusion/exclusion criteria for IR-CAD based on a protocol specifically designed for the clinical management of IR-CAD patients. The results of the above examinations will be used as the examination results of the case group of the present IR-CAD case-control study. While patients in the control group of the present case-control study will undergo similar examinations after enrollment according to the protocol of the present case-control study.
The information regarding the baseline characteristics and the examination results, including demographics, clinical features, lab results, imaging findings, and prior treatment, will be collected and compared between the case group and the control group.
The primary endpoint is the rate of elevated erythrocyte sedimentation rate (ESR).
Eligible patients will be enrolled in the case group and the control group with a 2:1 ratio. The primary endpoint of the present case-control study is elevated erythrocyte sedimentation rate (ESR), which is defined as ESR > 15 mm for male, or ESR > 20 mm for female. In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR. Based on currently available data from the IR-CAD cohort study, the rate of elevated ESR in the case group (IR-CAD patients) is 88.9% (8/9). The investigators hypothesize that the rate of elevated ESR in the control group (AS-CAD patients) is 20%. In consequence, 20 patients in the case group and 10 patients in the control group would be required to test the difference of the rate of the primary endpoint between the two groups at a significance level of 0.05 (α = 0.05) with a power of 90% (β = 0.10) and a drop-out rate of 20%.
Continuous variables will be presented as mean ± standard deviation (SD) or median (interquartile range [IQR]) and compared with two-sample t-test or Wilcoxon rank sum test, as appropriate. Categorical data will be demonstrated as n (%) and compared using Chi-square test or Fisher's exact test, as appropriate.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis, Coronary Artery Disease Progression, Inflammation, Inflammatory Disease
- Being tested
- Protocol-defined Examinations
- Keywords
- Coronary Artery Disease, Coronary Revascularization, Progression, Disease, Inflammation, Characteristics Disease
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Inflammation, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-defined ExaminationsDiagnostic test
Lab tests (blood and urine and stool routine tests, hepatic and renal and thyroid function tests, tests for metabolic markers, tests for cardiac biomarkers, thrombosis-related tests, rheumatology tests, tests for inflammation markers), electrocardiography, echocardiography, Birmingham Vasculitis Activity Score (BVAS-3), 6-minute walk test, 1-minute squat test, vascular ultrasound, fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT), coronary angiography, optical coherence tomography (OCT), tests for exploratory biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | IR-CAD patients (from the IR-CAD cohort study) Receives: Diagnostic Test: Protocol-defined Examinations | |
| Control Group | AS-CAD patients Receives: Diagnostic Test: Protocol-defined Examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated erythrocyte sedimentation rate (ESR)
Percentage of patients with elevated ESR (> 15 mm for male or > 20 mm for female). In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR.
Measured: From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Secondary outcomes (106)
Age
Age in years.
Measured: On the day of enrollment.
Female sex
Percentage of patients with female sex.
Measured: On the day of enrollment.
Yellow race
Percentage of patients with yellow race.
Measured: On the day of enrollment.
Acute coronary syndrome (ACS)
Percentage of patients admitted due to ACS for the index hospitalization.
Measured: On the day of enrollment.
Chronic coronary syndrome (CCS).
Percentage of patients admitted due to CCS for the index hospitalization.
Measured: On the day of enrollment.
Hypertension
Percentage of patients with prior history of hypertension.
Measured: On the day of enrollment.
Dyslipidemia
Percentage of patients with prior history of dyslipidemia.
Measured: On the day of enrollment.
Diabetes
Percentage of patients with prior history of diabetes.
Measured: On the day of enrollment.
Smoking
Percentage of patients with prior history of smoking.
Measured: On the day of enrollment.
Old myocardial infarction (OMI)
Percentage of patients with prior history of OMI.
Measured: On the day of enrollment.
Percutaneous coronary intervention (PCI)
Percentage of patients with prior history of PCI.
Measured: On the day of enrollment.
Coronary artery bypass graft (CABG)
Percentage of patients with prior history of CABG.
Measured: On the day of enrollment.
Number of prior coronary revascularization
Number of prior coronary revascularization
Measured: On the day of enrollment.
Blood pressure
Measurement of blood pressure.
Measured: On the day of enrollment.
Heart rate
Measurement of heart rate.
Measured: On the day of enrollment.
Body weight
Measurement of body weight.
Measured: On the day of enrollment.
Height
Measurement of height.
Measured: On the day of enrollment.
Body mass index (BMI)
BMI = Body weight [kg] / (Height [m])^2
Measured: On the day of enrollment.
Antithrombotic agents
Percentage of patients on antithrombotic agents.
Measured: On the day of enrollment.
β-blockers
Percentage of patients on β-blockers.
Measured: On the day of enrollment.
Blood pressure-lowering agents
Percentage of patients on blood pressure-lowering agents.
Measured: On the day of enrollment.
Lipid-lowering agents
Percentage of patients on lipid-lowering agents.
Measured: On the day of enrollment.
Hypoglycemic agents
Percentage of patients on hypoglycemic agents.
Measured: On the day of enrollment.
Glucocorticoids
Percentage of patients on glucocorticoids.
Measured: On the day of enrollment.
Immunosuppressive agents
Percentage of patients on immunosuppressive agents.
Measured: On the day of enrollment.
Other immunosuppressive therapy
Percentage of patients on other immunosuppressive therapy.
Measured: On the day of enrollment.
Major adverse cardiovascular events (MACE)
Percentage of patients with death, or Q wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
Measured: From the last coronary revascularization up to the day of enrollment.
Target vessel related major adverse cardiovascular events (TV-MACE)
Percentage of patients with cardiovascular death, or target vessel related Q wave myocardial infarction, or target vessel related unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or target vessel related unplanned myocardial ischemia-driven hospitalization.
Measured: From the last coronary revascularization up to the day of enrollment.
Hemoglobin
Test result of hemoglobin.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Red blood cell
Test result of red blood cell count.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
White blood cell
Test result of white blood cell count.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Platelet
Test result of platelet count
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Alanine aminotransferase (ALT)
Test result of ALT.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Aspartate aminotransferase (AST)
Test result of AST.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Gamma-glutamyl transferase (GGT)
Test result of GGT.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Alkaline phosphatase (ALP)
Test result of ALP.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Lactate dehydrogenase (LDH)
Test result of LDH.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Total bilirubin (T-Bil)
Test result of T-Bil.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Direct bilirubin (D-Bil)
Test result of D-Bil.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Albumin
Test result of Albumin
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Creatinine
Test result of creatinine.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Blood urea nitrogen (BUN)
Test result of BUN.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Triiodothyronine (T3)
Test result of T3.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Thyroxine (T4)
Test result of T4.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Free triiodothyronine (FT3)
Test result of FT3.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Free thyroxine (FT4)
Test result of FT4.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Thyroid-stimulating hormone (TSH)
Test result of TSH.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Total cholesterol (TC)
Test result of TC.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Low-density lipoprotein cholesterol (LDL-C)
Test result of LDL-C.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
High-density lipoprotein cholesterol (HDL-C)
Test result of HDL-C.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Triglyceride (TG)
Test result of TG.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Apolipoprotein A (ApoA)
Test result of ApoA.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Apolipoprotein B (ApoB)
Test result of ApoB.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Lipoprotein (a) (Lp[a])
Test result of Lp(a).
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Fasting blood glucose (FBG)
Test result of FBG.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Hemoglobin A1c (HbA1c).
Test result of HbA1c.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Cardiac troponin I (cTnI)
Test result of cTnI.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Creatine kinase-myocardial band (CK-MB)
Test result of CK-MB.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Creatine kinase (CK)
Test result of CK.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
B-type natriuretic peptide (BNP)
Test result of BNP.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
N-terminal pro-B-type natriuretic peptide (NT-proBNP).
Test result of NT-proBNP.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Lupus anticoagulant
Test result of lupus anticoagulant.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Antiphospholipid antibody
Test result of antiphospholipid antibody.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-phosphatidylserine antibody
Test result of anti-phosphatidylserine antibody.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-prothrombin antibody
Test result of anti-prothrombin antibody.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Protein S
Test result of Protein S.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Protein C
Test result of Protein C.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Activated protein C resistance (APC-R)
Test result of APC-R.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-thrombin III
Test result of anti-thrombin III.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Maximum platelet aggregation (MPA)
Test result of MPA.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-nuclear antibody (ANA)
Test result of ANA.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-neutrophil cytoplasmic antibody (ANCA)
Test result of ANCA.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-endothelial cell antibody (AECA)
Test result of AECA.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Rheumatoid factor (RF)
Test result of RF.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Anti-cyclic citrullinated peptide (Anti-CCP)
Test result of Anti-CCP.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Immunoglobulin
Test result of immunoglobulin.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Complement
Test result of complement.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Erythrocyte sedimentation rate (ESR)
Test result of ESR.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
High-sensitivity C-reactive protein (hs-CRP)
Test result of hs-CRP.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Interleukin (IL)-6
Test result of IL-6.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Tumor necrosis factor (TNF)-α.
Test result of TNF-α.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Pathological Q waves
Percentage of patients with pathological Q wave.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Dynamic ST-T changes
Percentage of patients with dynamic ST-T changes.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Segmental wall motion abnormality
Percentage of patients with segmental wall motion abnormality.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Left atrial diameter (LAD)
Measurement of LAD.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Left ventricular end-systolic diameter (LVESD)
Measurement of LVESD.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Left ventricular end-diastolic diameter (LVEDD)
Measurement of LVEDD.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Left ventricular ejection fraction (LVEF)
Measurement of LVEF.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Birmingham Vasculitis Activity Score (BVAS)
Result of BVAS (version 3) assessment.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Walking distance in 6 minutes
Result of 6-minute walk test (6MWT).
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Number of squats in 1 minute
Result of 1-minute squatting test (1MST).
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Temporal artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either temporal artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Carotid artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either carotid artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Vertebral artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either vertebral artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Subclavian artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either subclavian artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Iliac artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either Iliac artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Upper extremity artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either upper extremity artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Lower extremity artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either lower extremity artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Abdominal aorta stenosis
Percentage of patients with ≥ 50% diameter stenosis in abdominal aorta on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Celiac trunk stenosis
Percentage of patients with ≥ 50% diameter stenosis in celiac trunk on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Superior mesenteric artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in superior mesenteric artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Renal artery stenosis
Percentage of patients with ≥ 50% diameter stenosis in either renal artery on vascular ultrasound.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
SYNTAX score
Result of SYNTAX score assessment based on coronary angiogram.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Number of vessel segments with coronary lesions.
Number of vessel segments with ≥ 50% diameter stenosis on coronary angiogram.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Target lesion minimal lumen area (TL-MLA)
Measurement of the minimum lumen area of the target lesion on optical coherence tomography (OCT).
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Target lesion percent area stenosis (TL-%AS)
Measurement of percent area stenosis (% AS) of target lesion = { [ ( proximal RLA + distal RLA ) - (MLA × 2) ] / ( proximal RLA + distal RLA ) } × 100% in the cross-section with the MLA of the target lesion on optical coherence tomography (OCT). RLA = reference lumen area; MLA = minimum lumen area; % AS = percent area stenosis.
Measured: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start2 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiuZhenyu, Peking Union Medical College Hospital
- Investigators
- Zhenyu Liu, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007248
- Sponsor's protocol ID
- K3819
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
PubMed 32860058Neumann FJ, Sousa-Uva M. 'Ten commandments' for the 2018 ESC/EACTS Guidelines on Myocardial Revascularization. Eur Heart J. 2019 Jan 7;40(2):79-80. doi: 10.1093/eurheartj/ehy855. No abstract available.
PubMed 30615155Fernandez DM, Giannarelli C. Immune cell profiling in atherosclerosis: role in research and precision medicine. Nat Rev Cardiol. 2022 Jan;19(1):43-58. doi: 10.1038/s41569-021-00589-2. Epub 2021 Jul 15.
PubMed 34267377Deroissart J, Porsch F, Koller T, Binder CJ. Anti-inflammatory and Immunomodulatory Therapies in Atherosclerosis. Handb Exp Pharmacol. 2022;270:359-404. doi: 10.1007/164_2021_505.
PubMed 34251531Engelen SE, Robinson AJB, Zurke YX, Monaco C. Therapeutic strategies targeting inflammation and immunity in atherosclerosis: how to proceed? Nat Rev Cardiol. 2022 Aug;19(8):522-542. doi: 10.1038/s41569-021-00668-4. Epub 2022 Jan 31.
PubMed 35102320Tucker B, Vaidya K, Cochran BJ, Patel S. Inflammation during Percutaneous Coronary Intervention-Prognostic Value, Mechanisms and Therapeutic Targets. Cells. 2021 Jun 4;10(6):1391. doi: 10.3390/cells10061391.
PubMed 34199975Kalkman DN, Aquino M, Claessen BE, Baber U, Guedeney P, Sorrentino S, Vogel B, de Winter RJ, Sweeny J, Kovacic JC, Shah S, Vijay P, Barman N, Kini A, Sharma S, Dangas GD, Mehran R. Residual inflammatory risk and the impact on clinical outcomes in patients after percutaneous coronary interventions. Eur Heart J. 2018 Dec 7;39(46):4101-4108. doi: 10.1093/eurheartj/ehy633.
PubMed 30358832Guedeney P, Claessen BE, Kalkman DN, Aquino M, Sorrentino S, Giustino G, Farhan S, Vogel B, Sartori S, Montalescot G, Sweeny J, Kovacic JC, Krishnan P, Barman N, Dangas G, Kini A, Baber U, Sharma S, Mehran R. Residual Inflammatory Risk in Patients With Low LDL Cholesterol Levels Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2019 May 21;73(19):2401-2409. doi: 10.1016/j.jacc.2019.01.077.
PubMed 31097159Takahashi N, Dohi T, Endo H, Funamizu T, Wada H, Doi S, Kato Y, Ogita M, Okai I, Iwata H, Okazaki S, Isoda K, Miyauchi K, Shimada K. Residual Inflammation Indicated by High-Sensitivity C-Reactive Protein Predicts Worse Long-Term Clinical Outcomes in Japanese Patients after Percutaneous Coronary Intervention. J Clin Med. 2020 Apr 6;9(4):1033. doi: 10.3390/jcm9041033.
PubMed 32268533Kikuchi S, Okada K, Hibi K, Maejima N, Yabu N, Uchida K, Tamura K, Kimura K. Coronary arteritis: a case series. Eur Heart J Case Rep. 2020 Feb 17;4(2):1-6. doi: 10.1093/ehjcr/ytaa011. eCollection 2020 Apr.
PubMed 32352046Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. No abstract available.
PubMed 19758907Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
PubMed 30165617Braunwald E. Unstable angina. A classification. Circulation. 1989 Aug;80(2):410-4. doi: 10.1161/01.cir.80.2.410. No abstract available.
PubMed 2752565
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Case-control Study
- ClinicalTrials.gov ID
- NCT06007248
- Acronym / sponsor ID
- K3819
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis, Coronary Artery Disease Progression, Inflammation, Inflammatory Disease
- Keywords
- Coronary Artery Disease, Coronary Revascularization, Progression, Disease, Inflammation, Characteristics Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.
Detailed description
A special type of coronary artery disease (CAD) has been identified in the investigators' clinical practice, which has completely different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD). The patients often have sterile inflammatory diseases and/or clinical evidence of inflammation, whose CAD progresses rapidly, recurs frequently, and responds poorly to intensified secondary prevention of AS-CAD, especially after percutaneous coronary intervention (PCI). The investigators name this special type of CAD with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD). Currently, the overall disease characteristics of IR-CAD remain unknown.
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.
The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients were diagnosed as IR-CAD if they have 1) evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization) myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnosis of inflammatory diseases or use of immunosuppressive therapy). The comprehensive treatment for IR-CAD included: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies.
Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study. Patients will be diagnoses as AS-CAD if they 1) are ≥ 45 but < 65 years of age; 2) are receiving standard treatment for secondary prevention of AS-CAD after the last PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI) myocardial ischemia (typical symptoms and non-invasive evidence); 4) do not have angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
Patients in the IR-CAD cohort study underwent examinations after they met the inclusion/exclusion criteria for IR-CAD based on a protocol specifically designed for the clinical management of IR-CAD patients. The results of the above examinations will be used as the examination results of the case group of the present IR-CAD case-control study. While patients in the control group of the present case-control study will undergo similar examinations after enrollment according to the protocol of the present case-control study.
The information regarding the baseline characteristics and the examination results, including demographics, clinical features, lab results, imaging findings, and prior treatment, will be collected and compared between the case group and the control group.
The primary endpoint is the rate of elevated erythrocyte sedimentation rate (ESR).
Eligible patients will be enrolled in the case group and the control group with a 2:1 ratio. The primary endpoint of the present case-control study is elevated erythrocyte sedimentation rate (ESR), which is defined as ESR > 15 mm for male, or ESR > 20 mm for female. In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR. Based on currently available data from the IR-CAD cohort study, the rate of elevated ESR in the case group (IR-CAD patients) is 88.9% (8/9). The investigators hypothesize that the rate of elevated ESR in the control group (AS-CAD patients) is 20%. In consequence, 20 patients in the case group and 10 patients in the control group would be required to test the difference of the rate of the primary endpoint between the two groups at a significance level of 0.05 (α = 0.05) with a power of 90% (β = 0.10) and a drop-out rate of 20%.
Continuous variables will be presented as mean ± standard deviation (SD) or median (interquartile range [IQR]) and compared with two-sample t-test or Wilcoxon rank sum test, as appropriate. Categorical data will be demonstrated as n (%) and compared using Chi-square test or Fisher's exact test, as appropriate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Diagnostic Test: Protocol-defined ExaminationsIR-CAD patients (from the IR-CAD cohort study) |
| Control Group | – | Diagnostic Test: Protocol-defined ExaminationsAS-CAD patients |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study.
Key inclusion criteria (23 listed)
- 18 years of age or older, male or female.
- Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- Prior history of coronary revascularization (PCI or coronary artery bypass graft [CABG]).
- Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
- Hospitalization due to rapidly-progressive myocardial ischemia:
Key exclusion criteria (16 listed)
- Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
- Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
- Active acute or chronic infection (human immunodeficiency virus [HIV], tuberculosis, et al).
- Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
- Vital organ failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol-defined ExaminationsLab tests (blood and urine and stool routine tests, hepatic and renal and thyroid function tests, tests for metabolic markers, tests for cardiac biomarkers, thrombosis-related tests, rheumatology tests, tests for inflammation markers), electrocardiography, echocardiography, Birmingham Vasculitis Activity Score (BVAS-3), 6-minute walk test, 1-minute squat test, vascular ultrasound, fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT), coronary angiography, optical coherence tomography (OCT), tests for exploratory biomarkers. | Diagnostic test | Case Group, Control Group |
Primary outcome
Elevated erythrocyte sedimentation rate (ESR)
Time frame: From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Percentage of patients with elevated ESR (> 15 mm for male or > 20 mm for female). In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR.
106 secondary outcomes
Age
Time frame: On the day of enrollment.
Female sex
Time frame: On the day of enrollment.
Yellow race
Time frame: On the day of enrollment.
Acute coronary syndrome (ACS)
Time frame: On the day of enrollment.
Chronic coronary syndrome (CCS).
Time frame: On the day of enrollment.
Hypertension
Time frame: On the day of enrollment.
Dyslipidemia
Time frame: On the day of enrollment.
Diabetes
Time frame: On the day of enrollment.
Smoking
Time frame: On the day of enrollment.
Old myocardial infarction (OMI)
Time frame: On the day of enrollment.
Percutaneous coronary intervention (PCI)
Time frame: On the day of enrollment.
Coronary artery bypass graft (CABG)
Time frame: On the day of enrollment.
Number of prior coronary revascularization
Time frame: On the day of enrollment.
Blood pressure
Time frame: On the day of enrollment.
Heart rate
Time frame: On the day of enrollment.
Body weight
Time frame: On the day of enrollment.
Height
Time frame: On the day of enrollment.
Body mass index (BMI)
Time frame: On the day of enrollment.
Antithrombotic agents
Time frame: On the day of enrollment.
β-blockers
Time frame: On the day of enrollment.
Blood pressure-lowering agents
Time frame: On the day of enrollment.
Lipid-lowering agents
Time frame: On the day of enrollment.
Hypoglycemic agents
Time frame: On the day of enrollment.
Glucocorticoids
Time frame: On the day of enrollment.
Immunosuppressive agents
Time frame: On the day of enrollment.
Other immunosuppressive therapy
Time frame: On the day of enrollment.
Major adverse cardiovascular events (MACE)
Time frame: From the last coronary revascularization up to the day of enrollment.
Target vessel related major adverse cardiovascular events (TV-MACE)
Time frame: From the last coronary revascularization up to the day of enrollment.
Hemoglobin
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Red blood cell
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
White blood cell
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Platelet
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Alanine aminotransferase (ALT)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Aspartate aminotransferase (AST)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Gamma-glutamyl transferase (GGT)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Alkaline phosphatase (ALP)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Lactate dehydrogenase (LDH)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Total bilirubin (T-Bil)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Direct bilirubin (D-Bil)
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Albumin
Time frame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 31504439Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
- Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Background: PubMed 32860058Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
- Background: PubMed 30615155Neumann FJ, Sousa-Uva M. 'Ten commandments' for the 2018 ESC/EACTS Guidelines on Myocardial Revascularization. Eur Heart J. 2019 Jan 7;40(2):79-80. doi: 10.1093/eurheartj/ehy855. No abstract available.
- Background: PubMed 34267377Fernandez DM, Giannarelli C. Immune cell profiling in atherosclerosis: role in research and precision medicine. Nat Rev Cardiol. 2022 Jan;19(1):43-58. doi: 10.1038/s41569-021-00589-2. Epub 2021 Jul 15.
- Background: PubMed 34251531Deroissart J, Porsch F, Koller T, Binder CJ. Anti-inflammatory and Immunomodulatory Therapies in Atherosclerosis. Handb Exp Pharmacol. 2022;270:359-404. doi: 10.1007/164_2021_505.
- Background: PubMed 35102320Engelen SE, Robinson AJB, Zurke YX, Monaco C. Therapeutic strategies targeting inflammation and immunity in atherosclerosis: how to proceed? Nat Rev Cardiol. 2022 Aug;19(8):522-542. doi: 10.1038/s41569-021-00668-4. Epub 2022 Jan 31.
- Background: PubMed 34199975Tucker B, Vaidya K, Cochran BJ, Patel S. Inflammation during Percutaneous Coronary Intervention-Prognostic Value, Mechanisms and Therapeutic Targets. Cells. 2021 Jun 4;10(6):1391. doi: 10.3390/cells10061391.
- Background: PubMed 30358832Kalkman DN, Aquino M, Claessen BE, Baber U, Guedeney P, Sorrentino S, Vogel B, de Winter RJ, Sweeny J, Kovacic JC, Shah S, Vijay P, Barman N, Kini A, Sharma S, Dangas GD, Mehran R. Residual inflammatory risk and the impact on clinical outcomes in patients after percutaneous coronary interventions. Eur Heart J. 2018 Dec 7;39(46):4101-4108. doi: 10.1093/eurheartj/ehy633.
- Background: PubMed 31097159Guedeney P, Claessen BE, Kalkman DN, Aquino M, Sorrentino S, Giustino G, Farhan S, Vogel B, Sartori S, Montalescot G, Sweeny J, Kovacic JC, Krishnan P, Barman N, Dangas G, Kini A, Baber U, Sharma S, Mehran R. Residual Inflammatory Risk in Patients With Low LDL Cholesterol Levels Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2019 May 21;73(19):2401-2409. doi: 10.1016/j.jacc.2019.01.077.
- Background: PubMed 32268533Takahashi N, Dohi T, Endo H, Funamizu T, Wada H, Doi S, Kato Y, Ogita M, Okai I, Iwata H, Okazaki S, Isoda K, Miyauchi K, Shimada K. Residual Inflammation Indicated by High-Sensitivity C-Reactive Protein Predicts Worse Long-Term Clinical Outcomes in Japanese Patients after Percutaneous Coronary Intervention. J Clin Med. 2020 Apr 6;9(4):1033. doi: 10.3390/jcm9041033.
- Background: PubMed 32352046Kikuchi S, Okada K, Hibi K, Maejima N, Yabu N, Uchida K, Tamura K, Kimura K. Coronary arteritis: a case series. Eur Heart J Case Rep. 2020 Feb 17;4(2):1-6. doi: 10.1093/ehjcr/ytaa011. eCollection 2020 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenyu Liu, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Artery Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Liu, M.D. (+861069155068, Pumch_lzy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elevated erythrocyte sedimentation rate (ESR) (time frame: From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06007248, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.