Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort … (NCT05860400) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study
China39 participantsStarted 2023-05-17
Plain-language summary
This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Fulfilling all the following criteria before initiation of comprehensive treatment:
✓.1 18 years of age or older, male or female.
✓.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
✓.3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).
✓.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.
✓.5 Hospitalization due to rapidly-progressive myocardial ischemia:
✓.6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses):
✓.7 Evidence of inflammation:
Exclusion criteria
✕. 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).
✕
What they're measuring
1
Major adverse cardiovascular events (MACE)
Timeframe: Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.