Coronary Artery DiseaseNCT05860400
Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort 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
This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis
- What is being tested?
- Healthy life style, Secondary prevention for atherosclerotic coronary artery disease and Immunosuppressive therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to Sep 2026
- How long will I take part?
- 24 Months
- 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: All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation.
Who may be able to join
- Fulfilling all the following criteria before initiation of comprehensive treatment:
- 1.1 18 years of age or older, male or female.
- 1.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- 1.3 Prior history of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]).
- 1.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
- 1.5 Hospitalization due to rapidly-progressive myocardial ischemia:
Show all 16Show fewer
- 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.
- 1.6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses):
- Occurred after the last coronary revascularization; and
- Related to myocardial ischemia (location, extent, severity, et al).
- 1.7 Evidence of inflammation:
- At least one of the markers indicating active inflammation has ever been elevated (erythrocyte sedimentation rate [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.
- Receiving comprehensive treatment, including ischemia-driven PCI which was performed no earlier than 40 days of the initiation of immunosuppressive therapy.
Who cannot join
- 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.
- Life expectancy < 1 year.
Show all 13Show fewer
- 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.
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: Efficacy and Safety of Comprehensive Treatment in Patients With Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Self-controlled Cohort Study
This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.
Read the detailed description
A special type of coronary artery disease (CAD) has been identified in our 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). We name this special type of CAD inflammation-associated rapidly-progressive coronary artery disease (IR-CAD).
The optimal treatment for IR-CAD remains unknown. We hypothesize that the rapid progression of IR-CAD might be associated with inflammation considering that: 1) inflammation is associated with poor prognosis in CAD patients after PCI; 2) IR-CAD patients often have sterile inflammatory diseases and/or clinical evidence of inflammation; 3) the disease progression of IR-CAD can be controlled to some extent with corticosteroids and immunosuppressive agents. Therefore, we incorporate immunosuppressive therapy into the overall management strategy of IR-CAD patients in clinical practice, developing comprehensive treatment, including: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies.
The present self-controlled cohort study is designed to evaluate the efficacy and safety of comprehensive treatment in about 39 IR-CAD patients by comparing the outcomes before with those after the initiation of comprehensive treatment in the same group of patients.
All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation. Patients were diagnosed as IR-CAD if they presented with 1) rapidly progressive myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD after the last coronary revascularization; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) related to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnoses of inflammatory diseases or use of immunosuppressive therapy). IR-CAD patients who have received comprehensive treatment will be enrolled in the present cohort study. The eligible patients will be followed for 24 months since the initiation of comprehensive treatment.
The primary efficacy endpoint is major adverse cardiovascular events (MACE). The key secondary efficacy endpoint is target vessel related major adverse cardiovascular events (TV-MACE). Other secondary efficacy endpoints include individual components of MACE and TV-MACE, exercise capacity, angiographic metrics of coronary lesions, and inflammation markers. The safety endpoints are major bleeding events and severe infection events.
For endpoints which are categorical variables, e.g., MACE, survival analysis will be used to compare the survival curves before treatment (from the last coronary revascularization before the initiation of comprehensive treatment to the first occurrence of MACE) with those after treatment (from the initiation of comprehensive treatment to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first). Event-free survival rates and relative risk will be calculated.
For endpoints which are continuous variables, e.g., inflammation markers, paired t-test or paired rank sum test will be used to compare the endpoint levels before treatment (before the initiation of comprehensive treatment or at baseline) with those after treatment (the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, after the initiation of comprehensive treatment).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis, Coronary Artery Disease Progression, Inflammation, Inflammatory Disease
- Being tested
- Healthy life style, Secondary prevention for atherosclerotic coronary artery disease, Immunosuppressive therapy, Coronary revascularization, Supportive therapies
- Keywords
- Coronary Artery Disease, Coronary Revascularization, Progression, Disease, Inflammation
- 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.
Healthy life styleBehavioural
Healthy diet, regular exercise, and quitting smoking
Secondary prevention for atherosclerotic coronary artery diseaseDrug
Antiplatelet therapy, as well as medications for control of heart rate, blood pressure, low-density lipoprotein cholesterol, and blood glucose
Immunosuppressive therapyDrug
Glucocorticoids and/or immunosuppressive agents
Coronary revascularizationProcedure or surgery
Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
Supportive therapiesDrug
Medical interventions for prevention and treatment of the side effects of the above treatment, such as abnormal liver function, hypocalcemia, hypokalemia, peptic ulcer, infection, et al.
| Study group | Role | What they receive |
|---|---|---|
| Pre-treatment Group | IR-CAD patients before receiving comprehensive treatment. Receives: Behavioral: Healthy life style; Drug: Secondary prevention for atherosclerotic coronary artery disease; Procedure: Coronary revascularization; Drug: Supportive therapies | |
| Post-treatment Group | IR-CAD patients after receiving comprehensive treatment. Receives: Behavioral: Healthy life style; Drug: Secondary prevention for atherosclerotic coronary artery disease; Drug: Immunosuppressive therapy; Procedure: Coronary revascularization; Drug: Supportive therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
The composite endpoint including death, or Q wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Secondary outcomes (19)
Target vessel related major adverse cardiovascular events (TV-MACE)
The composite endpoint including 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: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Death
All-cause death.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Myocardial infarction
Myocardial injury due to myocardial ischemia.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Target vessel related myocardial infarction
Myocardial infarction in the area supplied by the target vessel.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Unplanned myocardial ischemia-driven coronary revascularization
Unplanned coronary revascularization (PCI or CABG) due to myocardial ischemia.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Target vessel related unplanned myocardial ischemia-driven coronary revascularization
Unplanned coronary revascularization (PCI or CABG) in the target vessel due to myocardial ischemia.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Unplanned myocardial ischemia-driven hospitalization
Unplanned hospitalization due to myocardial ischemia.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Target vessel related unplanned myocardial ischemia-driven hospitalization
Unplanned hospitalization due to myocardial ischemia in the area supplied by the target vessel.
Measured: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Walking distance in 6 minutes
The result of 6-minute walk test (6MWT).
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Number of squats in 1 minute
The result of 1-minute squatting test (1MST).
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Target lesion minimal lumen area (TL-MLA)
The minimum lumen area of the target lesion on optical coherence tomography (OCT).
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Target lesion percent area stenosis (TL-%AS)
Percent area stenosis (% AS) = { [ ( 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: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
SYNTAX score
The result of SYNTAX score calculation.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Number of vessel segments with coronary lesions
Number of vessel segments with diameter stenosis ≥ 50% on coronary angiogram.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Erythrocyte sedimentation rate (ESR)
The result of erythrocyte sedimentation rate (ESR) test.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
High-sensitivity C-reactive protein (hs-CRP)
The result of serum high-sensitivity C-reactive protein (hs-CRP) test.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
interleukin (IL)-6
The result of serum interleukin (IL)-6 test.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Tumor necrosis factor (TNF)-α
The result of serum tumor necrosis factor (TNF)-α test.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Birmingham vasculitis activity score
The result of Birmingham Vasculitis Activity Score (version 3) calculation.
Measured: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start17 May 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 (16)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
- Target duration
- 24 Months
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
- NCT05860400
- Sponsor's protocol ID
- K3483
- Status last verified
- Nov 2025
- First submitted
- 8 May 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 32352046Thygesen 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 2752565Sianos 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 19758907
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
- Efficacy and Safety of Comprehensive Treatment in Patients With Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Self-controlled Cohort Study
- ClinicalTrials.gov ID
- NCT05860400
- Acronym / sponsor ID
- K3483
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 May 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.
This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.
Detailed description
A special type of coronary artery disease (CAD) has been identified in our 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). We name this special type of CAD inflammation-associated rapidly-progressive coronary artery disease (IR-CAD).
The optimal treatment for IR-CAD remains unknown. We hypothesize that the rapid progression of IR-CAD might be associated with inflammation considering that: 1) inflammation is associated with poor prognosis in CAD patients after PCI; 2) IR-CAD patients often have sterile inflammatory diseases and/or clinical evidence of inflammation; 3) the disease progression of IR-CAD can be controlled to some extent with corticosteroids and immunosuppressive agents. Therefore, we incorporate immunosuppressive therapy into the overall management strategy of IR-CAD patients in clinical practice, developing comprehensive treatment, including: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies.
The present self-controlled cohort study is designed to evaluate the efficacy and safety of comprehensive treatment in about 39 IR-CAD patients by comparing the outcomes before with those after the initiation of comprehensive treatment in the same group of patients.
All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation. Patients were diagnosed as IR-CAD if they presented with 1) rapidly progressive myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD after the last coronary revascularization; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) related to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnoses of inflammatory diseases or use of immunosuppressive therapy). IR-CAD patients who have received comprehensive treatment will be enrolled in the present cohort study. The eligible patients will be followed for 24 months since the initiation of comprehensive treatment.
The primary efficacy endpoint is major adverse cardiovascular events (MACE). The key secondary efficacy endpoint is target vessel related major adverse cardiovascular events (TV-MACE). Other secondary efficacy endpoints include individual components of MACE and TV-MACE, exercise capacity, angiographic metrics of coronary lesions, and inflammation markers. The safety endpoints are major bleeding events and severe infection events.
For endpoints which are categorical variables, e.g., MACE, survival analysis will be used to compare the survival curves before treatment (from the last coronary revascularization before the initiation of comprehensive treatment to the first occurrence of MACE) with those after treatment (from the initiation of comprehensive treatment to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first). Event-free survival rates and relative risk will be calculated.
For endpoints which are continuous variables, e.g., inflammation markers, paired t-test or paired rank sum test will be used to compare the endpoint levels before treatment (before the initiation of comprehensive treatment or at baseline) with those after treatment (the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, after the initiation of comprehensive treatment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment Group | – | Behavioral: Healthy life style, Drug: Secondary prevention for atherosclerotic coronary artery disease, Procedure: Coronary revascularization, Drug: Supportive therapiesIR-CAD patients before receiving comprehensive treatment. |
| Post-treatment Group | – | Behavioral: Healthy life style, Drug: Secondary prevention for atherosclerotic coronary artery disease, Drug: Immunosuppressive therapy, Procedure: Coronary revascularization, Drug: Supportive therapiesIR-CAD patients after receiving comprehensive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation.
Key inclusion criteria (16 listed)
- Fulfilling all the following criteria before initiation of comprehensive treatment:
- 1.1 18 years of age or older, male or female.
- 1.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- 1.3 Prior history of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]).
- 1.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
Key exclusion criteria (13 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 |
|---|---|---|
| Healthy life styleHealthy diet, regular exercise, and quitting smoking | Behavioural | Post-treatment Group, Pre-treatment Group |
| Secondary prevention for atherosclerotic coronary artery diseaseAntiplatelet therapy, as well as medications for control of heart rate, blood pressure, low-density lipoprotein cholesterol, and blood glucose | Drug | Post-treatment Group, Pre-treatment Group |
| Immunosuppressive therapyGlucocorticoids and/or immunosuppressive agents | Drug | Post-treatment Group |
| Coronary revascularizationPercutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). | Procedure or surgery | Post-treatment Group, Pre-treatment Group |
| Supportive therapiesMedical interventions for prevention and treatment of the side effects of the above treatment, such as abnormal liver function, hypocalcemia, hypokalemia, peptic ulcer, infection, et al. | Drug | Post-treatment Group, Pre-treatment Group |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
The composite endpoint including death, or Q wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
19 secondary outcomes
Target vessel related major adverse cardiovascular events (TV-MACE)
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Death
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Myocardial infarction
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Target vessel related myocardial infarction
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Unplanned myocardial ischemia-driven coronary revascularization
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Target vessel related unplanned myocardial ischemia-driven coronary revascularization
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Unplanned myocardial ischemia-driven hospitalization
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Target vessel related unplanned myocardial ischemia-driven hospitalization
Time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
Walking distance in 6 minutes
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Number of squats in 1 minute
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Target lesion minimal lumen area (TL-MLA)
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Target lesion percent area stenosis (TL-%AS)
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
SYNTAX score
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Number of vessel segments with coronary lesions
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Erythrocyte sedimentation rate (ESR)
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
interleukin (IL)-6
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Tumor necrosis factor (TNF)-α
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
Birmingham vasculitis activity score
Time frame: Before treatment: the timepoint before the initiation of comprehensive treatment, or at baseline. After treatment: the timepoint of the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first.
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.
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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 16 inclusion and 13 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?
Major adverse cardiovascular events (MACE) (time frame: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.). 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 NCT05860400, which also lists 16 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.