Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a Cohort Study

NCT06845410 | Recruiting

• 1 other identifier: K6722
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cohort study to investigate the clinical features, current treatment and clinical outcomes in patients with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).

Conditions

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

Keywords

Coronary Artery Disease; 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.

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

Secondary Outcomes (13)

• Death

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

• Q-wave myocardial infarction

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

• Unplanned myocardial ischemia-driven coronary revascularization

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

• Unplanned myocardial ischemia-driven hospitalization

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

• Walking distance in 6 minutes

  At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.

Other Outcomes (2)

• Major bleeding events

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

• Severe infection events

  From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

Study Arms (1)

INR-CAD Group

Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.

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

INR-CAD 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

INR-CAD Group

Immunosuppressive Therapy DRUG

Glucocorticoids and/or immunosuppressive agents

INR-CAD Group

Coronary revascularization PROCEDURE

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

INR-CAD 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.

INR-CAD 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 have been admitted to the Department of Cardiology, Peking Union Medical College Hospital (PUMCH) since January 1, 2022 will be screened for study participation.

You may qualify if:

• 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).
• Meeting the clinical diagnostic criteria for INR-CAD, including: (1) Angiographic evidence of coronary lesions (≥ 50% diameter stenosis, de novo or restenotic); (2) Evidence of chronic inflammation within 24 months: (A) Positive inflammatory markers (erythrocyte sedimentation rate \[ESR\], high-sensitivity C-reactive protein \[hs-CRP\], interleukin-6 \[IL-6\], tumor necrosis factor-alpha \[TNF-α\], et al; at least twice, ≥ 12 weeks apart), or (B) Positive autoantibodies (at least twice, ≥ 12 weeks apart), or (C) Established diagnosis of chronic inflammatory diseases (autoimmune disease, systemic vasculitis, psoriasis, tuberculosis, et al), or (D) Receiving immunosuppressive therapy (glucocorticoids, immunosuppressive agents, et al).
• NOT meeting the clinical diagnostic criteria for IR-CAD, including: (1) Hospitalization due to myocardial ischemia, including: (A) Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV), and (B) Non-invasive evidence of myocardial ischemia; (2) Angiographic evidence of new or worsened coronary lesions (de novo or restenotic) considered relevant to myocardial ischemia, which occurred: (A) Within 6 months of last coronary angiography in any patients, or (B) Within 12 months of last coronary angiography in patients receiving immunosuppressive therapy within 24 months.
• Received, or are receiving, or will receive the 24-month clinical follow-up defined by the clinical follow-up protocol for INR-CAD.

You may not qualify if:

• 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.
• 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

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

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: February 20, 2025
• First Posted: February 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)