NCT06007248 Disease Characteristics of IR-CAD: a Case-control Study
| NCT ID | NCT06007248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-11-02 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 between 20 patients with IR-CAD and 10 patients with AS-CAD.
Eligibility Criteria
Inclusion Criteria: Case group (IR-CAD patients): 1. 18 years of age or older, male or female. 2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile). 3. Prior history of coronary revascularization (PCI or coronary artery bypass graft \[CABG\]). 4. Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization. 5. 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. 6. Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia. 7. 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): 1. ≥ 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. 2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile). 3. Currently, 12±6 months after the last PCI. 4. Receiving standard treatment for secondary prevention of AS-CAD after the last PCI. 5. Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization. 6. 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. 7. No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia. Exclusion Criteria: Case group (IR-CAD patients): 1. Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al). 2. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al). 3. Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al). 4. Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment). 5. Vital organ failure. 6. Life expectancy \< 1 year. 7. Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents. 8. In pregnancy or breast-feeding, or with intention to be pregnant during the study period. 9. Risk of non-compliance (history of drug addiction or alcohol abuse, et al). 10. Previous enrollment in this study. 11. Participation in another study within 30 days. 12. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al). 13. 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).
Contact & Investigator
Zhenyu Liu, M.D.
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06007248 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 64 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06007248 currently recruiting?
Yes, NCT06007248 is actively recruiting participants. Contact the research team at Pumch_lzy@163.com for enrollment information.
Where is the NCT06007248 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06007248 clinical trial?
NCT06007248 is sponsored by Peking Union Medical College Hospital. The principal investigator is Zhenyu Liu, M.D. at Peking Union Medical College Hospital. The trial plans to enroll 30 participants.