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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Disease Characteristics of IR-CAD: a Case-control Study," is exploring the differences in health features between two groups of patients with coronary artery disease (CAD). The study aims to understand the characteristics of patients who have experienced rapid worsening of their heart condition after previous treatments, called IR-CAD, compared to those with more stable conditions, known as AS-CAD. By looking at factors like demographics, clinical features, lab results, and imaging findings, researchers hope to gain insights into why some patients have more severe symptoms and complications.

To participate in this study, patients need to meet specific criteria. For the IR-CAD group, eligible participants must be at least 18 years old, have a history of heart procedures like angioplasty or bypass surgery, and show signs of worsening heart issues within the last six months. The AS-CAD group includes individuals aged 45 to 65 who are currently stable and have not experienced rapid heart problems. Participants can expect to undergo tests and evaluations to help researchers learn more about their conditions. This study is currently recruiting and aims to improve our understanding of coronary artery disease and its progression.

Gender

ALL

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).