Disease Characteristics of IR-CAD: a Case-control Study

Recruiting now

Conditions studied: Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis, Coronary Artery Disease Progression, Inflammation, Inflammatory Disease, Inflammation Vascular

In brief

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.

Key facts

Study ID

NCT06007248

Run by

Peking Union Medical College Hospital

People needed

30

Starts

2023-11-02

Expected to finish

2026-09-01

Last updated by the study team

2025-11-19

Who can join

Age: 45 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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.
• 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).

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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