Efficacy and Safety of Comprehensive Treatment in Patients with IR-CAD: a Self-controlled Cohort Study

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · May 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a comprehensive treatment approach for patients with a specific type of rapidly-progressive coronary artery disease (IR-CAD) that is linked to inflammation. The study aims to compare the health outcomes of participants before they receive treatment and after they have undergone the treatment, all within the same group of patients. This means that researchers will be able to see how much improvement, if any, occurs after the treatment is given.

To be eligible for this trial, participants must be at least 18 years old and have previously undergone procedures to improve blood flow in their heart, such as angioplasty or bypass surgery. They should also be experiencing significant symptoms of heart problems and have evidence of new blockages in their coronary arteries. Additionally, markers in their blood must indicate active inflammation, which is a sign of their condition. Participants can expect to receive a treatment plan that includes both medical management and procedures to address their heart issues, and they will be closely monitored throughout the study. It's important to note that certain health conditions or treatments may disqualify someone from participating, so eligibility will be assessed carefully.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Fulfilling all the following criteria before initiation of comprehensive treatment:
• • 1.1 18 years of age or older, male or female.
• • 1.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• • 1.3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).
• • 1.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
• 1.5 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.
• 1.6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses):
• • Occurred after the last coronary revascularization; and
• • Related to myocardial ischemia (location, extent, severity, et al).
• 1.7 Evidence of inflammation:
• • At least one of the markers indicating active inflammation has ever been elevated (erythrocyte sedimentation rate \[ESR\], 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.
• • 2. Receiving comprehensive treatment, including ischemia-driven PCI which was performed no earlier than 40 days of the initiation of immunosuppressive therapy.
• Exclusion Criteria:
• • 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.