Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study

NCT05860400 | Recruiting

• 1 other identifier: K3483
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis; Coronary Artery Restenosis; Coronary Artery Disease Progression; Inflammation; Inflammatory Disease; Inflammation Vascular

Keywords

Coronary Artery Disease; Coronary Revascularization; Progression, Disease; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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 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 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 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 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.

Other Outcomes (2)

• Major bleeding events

  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.

• Severe infection events

  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.

Study Arms (2)

Pre-treatment Group

IR-CAD patients before receiving comprehensive treatment.

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.

Behavioral: Healthy life style; Drug: Secondary prevention for atherosclerotic coronary artery disease; Drug: Immunosuppressive therapy; Procedure: Coronary revascularization; Drug: Supportive therapies

Interventions

Healthy life style BEHAVIORAL

Healthy diet, regular exercise, and quitting smoking

Post-treatment Group; Pre-treatment Group

Secondary prevention for atherosclerotic coronary artery disease DRUG

Antiplatelet therapy, as well as medications for control of heart rate, blood pressure, low-density lipoprotein cholesterol, and blood glucose

Post-treatment Group; Pre-treatment Group

Immunosuppressive therapy DRUG

Glucocorticoids and/or immunosuppressive agents

Post-treatment Group

Coronary revascularization PROCEDURE

Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).

Post-treatment Group; Pre-treatment Group

Supportive therapies DRUG

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.

Post-treatment Group; Pre-treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Fulfilling all the following criteria before initiation of comprehensive treatment:
• years of age or older, male or female.
• Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).
• Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
• Hospitalization due to rapidly-progressive myocardial ischemia:
• 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 stenoses or restenoses):
• Occurred after the last coronary revascularization; and
• Related to myocardial ischemia (location, extent, severity, et al).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be retained for potential RNA sequencing, proteomics, and metabolomics studies.

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis; Inflammation; Disease Progression

Interventions

Secondary Prevention; Immunosuppression Therapy; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health; Immunotherapy; Immunomodulation; Biological Therapy; Immunologic Techniques; Investigative Techniques; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zhenyu Liu, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Liu, M.D.

CONTACT

+861069155068; Pumch_lzy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: May 17, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)