Coronary Artery DiseaseNCT07239921
Disease Characteristics of R-CAD
An observational study of Coronary Artery Disease and Coronary Artery Disease Progression, run by Peking Union Medical College Hospital.
Trial summary
The present case-control study is designed to investigate the disease characteristics of rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between patients in the case group (approximately 34 patients with R-CAD) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease Progression, Coronary Stenosis
- What is being tested?
- Protocol-defined Examinations and Evaluations
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who fulfill the inclusion/exclusion criteria for R-CAD defined by the protocol of the present case-control study will be enrolled in the case group of the present case-control study. Patients who fulfill the inclusion/exclusion criteria for NR-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 (R-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 CABG).
- Receiving standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization.
- Rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization:
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- Typical symptoms of angina (Canadian Cardiovascular Society [CCS] classification III-IV) and non-invasive evidence of myocardial ischemia; and
- Occurred within 6 months of the latest ischemia-driven hospitalization and/or coronary revascularization.
- Rapidly progressive coronary lesions leading to myocardial ischemia:
- Angiographic evidence of new-onset or worsened coronary de novo or restenotic lesions relevant to myocardial ischemia, and
- Occurred within 6 months of the latest ischemia-driven coronary angiography and/or revascularization.
- Control Group (NR-CAD patients):
- 35 to 75 years old*, male or female. (* Based on the age distribution characteristics of patients who have been diagnosed as R-CAD.)
- Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- Currently, at 12±6 months after the latest PCI.
- Receiving standard treatment for secondary prevention of AS-CAD after the latest PCI.
- Coronary angiography and/or optical coherence tomography (OCT) performed during the index hospitalization.
- No evidence of rapidly progressive myocardial ischemia and coronary lesions, i.e., not fulfilling items 5) and 6) of the inclusion criteria for R-CAD.
Who cannot join
- Receiving immunosuppressive therapy within 6 months.
- 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 malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
- Vital organ failure.
- Life expectancy < 1 year.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Disease Characteristics of Rapidly Progressive Coronary Artery Disease (R-CAD): A Case-control Study
The present case-control study is designed to investigate the disease characteristics of rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between patients in the case group (approximately 34 patients with R-CAD) and those in the control group (approximately 18 patients with non-rapidly progressive coronary artery disease [NR-CAD]).
Read the detailed description
The majority of coronary artery disease (CAD) is atherosclerotic coronary artery disease (AS-CAD), the pathological basis of which is atherosclerosis. Secondary prevention, including healthy life style and medical treatment, effectively controls the progression of AS-CAD. Coronary revascularization, including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the dominant treatment modalities to restore the patency and/or blood flow of the diseased coronary arteries.
A special type of CAD is identified in the investigators' clinical practice, which progresses rapidly and recurs frequently after PCI or CABG, and responds poorly to intensified secondary prevention for AS-CAD. The investigators name this special type of CAD with rapidly progressive coronary artery disease (R-CAD), which has significantly different clinical features from those of typical AS-CAD. The CAD without the above characteristics is named with non-rapidly progressive coronary artery disease (NR-CAD).
Currently, the disease characteristics of R-CAD remain unknown. It has been identified that a proportion of R-CAD patients demonstrate certain manifestations of inflammation, including positive inflammatory markers, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases, or use of immunosuppressive therapy, whose R-CAD is named as inflammation-associated rapidly progressive coronary artery disease (IR-CAD). However, the rest of R-CAD patients demonstrate no manifestations of inflammation. Therefore, the present case-control study is designed to investigate the disease characteristics of the overall R-CAD patients by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between the case group (approximately 34 patients with R-CAD) and the control group (approximately 18 patients with NR-CAD).
Patients will be enrolled in the case group (R-CAD patients) of the present case-control study if they 1) have prior history of coronary revascularization (PCI or CABG); 2) received standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization; 3) have evidence of rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization; 4) have angiographic evidence of rapidly progressive coronary lesions leading to myocardial ischemia.
Patients will be enrolled in the control group (NR-CAD patients) of the present case-control study if they 1) are 35 to 75 years old; 2) received standard treatment for secondary prevention of AS-CAD after the latest PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization; 4) do not have angiographic evidence of rapidly progressive coronary lesions leading to myocardial ischemia.
Once enrolled, patients in both groups will receive examinations and evaluations according to a clinical management protocol specifically designed for the clinical management of R-CAD patients. The information regarding the baseline characteristics and the results of examinations and evaluations, 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) or high-sensitivity C-reactive protein (hs-CRP).
- Conditions
- Coronary Artery Disease, Coronary Artery Disease Progression, Coronary Stenosis, Coronary Restenosis, Coronary Stent Occlusion, Myocardial Revascularization
- Being tested
- Protocol-defined Examinations and Evaluations
- Keywords
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Myocardial Revascularization, Percutaneous Coronary Intervention, Disease Progression, Disease Attributes
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Disease Progression, Disease Attributes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-defined Examinations and EvaluationsDiagnostic 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, 6-minute walk test, vascular ultrasound, coronary angiography, optical coherence tomography (OCT), fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT), photon-counting detector coronary computed tomography angiography (PCD-CCTA), tests for exploratory biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | R-CAD patients Receives: Diagnostic Test: Protocol-defined Examinations and Evaluations | |
| Control Group | NR-CAD patients Receives: Diagnostic Test: Protocol-defined Examinations and Evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated ESR or hs-CRP
Percentage of patients with elevated ESR (> 15 mm/h for male or > 20 mm/h for female) or hs-CRP (≥ 2 mg/L).
Measured: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Secondary outcomes (4)
Positive autoantibodies
Percentage of patients with positive autoantibodies (anti-nuclear antibody [ANA], anti-neutrophil cytoplasmic antibody [ANCA], anti-endothelial cell antibody [AECA], lupus anticoagulant [LA], antiphospholipid antibody (APL) (anti-cardiolipin antibody [ACL], anti-beta2-glycoprotein 1 antibody [abeta2GP1]), anti-phosphatidylserine antibody [APSA], rheumatoid factor [RF], anti-cyclic citrullinated peptide antibody [anti-CCP], et al.).
Measured: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Established diagnosis of chronic inflammatory diseases
Percentage of patients with established diagnosis of chronic inflammatory diseases (chronic infectious disease, autoimmune disease, other chronic inflammatory diseases, et al.).
Measured: Up to 14 days after enrollment
Elevated ESR or hs-CRP, or positive autoantibodies
Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies.
Measured: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases
Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases.
Measured: For elevated ESR or hs-CRP and positive autoantibodies: from 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy; for established diagnosis of chronic inflammatory diseases: up to 14 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 52 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
- NCT07239921
- Sponsor's protocol ID
- K9096
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Characteristics of Rapidly Progressive Coronary Artery Disease (R-CAD): A Case-control Study
- ClinicalTrials.gov ID
- NCT07239921
- Acronym / sponsor ID
- K9096
- Conditions
- Coronary Artery Disease, Coronary Artery Disease Progression, Coronary Stenosis, Coronary Restenosis, Coronary Stent Occlusion, Myocardial Revascularization
- Keywords
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Myocardial Revascularization, Percutaneous Coronary Intervention, Disease Progression, Disease Attributes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Nov 2025 (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 rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between patients in the case group (approximately 34 patients with R-CAD) and those in the control group (approximately 18 patients with non-rapidly progressive coronary artery disease [NR-CAD]).
Detailed description
The majority of coronary artery disease (CAD) is atherosclerotic coronary artery disease (AS-CAD), the pathological basis of which is atherosclerosis. Secondary prevention, including healthy life style and medical treatment, effectively controls the progression of AS-CAD. Coronary revascularization, including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the dominant treatment modalities to restore the patency and/or blood flow of the diseased coronary arteries.
A special type of CAD is identified in the investigators' clinical practice, which progresses rapidly and recurs frequently after PCI or CABG, and responds poorly to intensified secondary prevention for AS-CAD. The investigators name this special type of CAD with rapidly progressive coronary artery disease (R-CAD), which has significantly different clinical features from those of typical AS-CAD. The CAD without the above characteristics is named with non-rapidly progressive coronary artery disease (NR-CAD).
Currently, the disease characteristics of R-CAD remain unknown. It has been identified that a proportion of R-CAD patients demonstrate certain manifestations of inflammation, including positive inflammatory markers, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases, or use of immunosuppressive therapy, whose R-CAD is named as inflammation-associated rapidly progressive coronary artery disease (IR-CAD). However, the rest of R-CAD patients demonstrate no manifestations of inflammation. Therefore, the present case-control study is designed to investigate the disease characteristics of the overall R-CAD patients by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between the case group (approximately 34 patients with R-CAD) and the control group (approximately 18 patients with NR-CAD).
Patients will be enrolled in the case group (R-CAD patients) of the present case-control study if they 1) have prior history of coronary revascularization (PCI or CABG); 2) received standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization; 3) have evidence of rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization; 4) have angiographic evidence of rapidly progressive coronary lesions leading to myocardial ischemia.
Patients will be enrolled in the control group (NR-CAD patients) of the present case-control study if they 1) are 35 to 75 years old; 2) received standard treatment for secondary prevention of AS-CAD after the latest PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization; 4) do not have angiographic evidence of rapidly progressive coronary lesions leading to myocardial ischemia.
Once enrolled, patients in both groups will receive examinations and evaluations according to a clinical management protocol specifically designed for the clinical management of R-CAD patients. The information regarding the baseline characteristics and the results of examinations and evaluations, 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) or high-sensitivity C-reactive protein (hs-CRP).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Diagnostic Test: Protocol-defined Examinations and EvaluationsR-CAD patients |
| Control Group | – | Diagnostic Test: Protocol-defined Examinations and EvaluationsNR-CAD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who fulfill the inclusion/exclusion criteria for R-CAD defined by the protocol of the present case-control study will be enrolled in the case group of the present case-control study. Patients who fulfill the inclusion/exclusion criteria for NR-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 (18 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 CABG).
- Receiving standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization.
- Rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization:
Key exclusion criteria (12 listed)
- Receiving immunosuppressive therapy within 6 months.
- 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 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 Examinations and EvaluationsLab 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, 6-minute walk test, vascular ultrasound, coronary angiography, optical coherence tomography (OCT), fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT), photon-counting detector coronary computed tomography angiography (PCD-CCTA), tests for exploratory biomarkers. | Diagnostic test | Case Group, Control Group |
Primary outcome
Elevated ESR or hs-CRP
Time frame: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Percentage of patients with elevated ESR (> 15 mm/h for male or > 20 mm/h for female) or hs-CRP (≥ 2 mg/L).
4 secondary outcomes
Positive autoantibodies
Time frame: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Established diagnosis of chronic inflammatory diseases
Time frame: Up to 14 days after enrollment
Elevated ESR or hs-CRP, or positive autoantibodies
Time frame: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases
Time frame: For elevated ESR or hs-CRP and positive autoantibodies: from 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy; for established diagnosis of chronic inflammatory diseases: up to 14 days after
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 28 Nov 2025.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Artery Disease Progression, run by Peking Union Medical College Hospital.
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 18 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 ESR or hs-CRP (time frame: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.