Status:
RECRUITING
Disease Characteristics of IR-CAD: a Case-control Study
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Coronary Artery Disease
Coronary Artery Stenosis
Eligibility:
All Genders
45-64 years
Brief Summary
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 bet...
Detailed Description
A special type of coronary artery disease (CAD) has been identified in the investigators' clinical practice, which has completely different clinical features from those of typical atherosclerotic coro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
November 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06007248
Start Date
November 2 2023
End Date
September 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730