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NCT05701319
Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes
Conditions: LMN Disease
Sex: All
Enrollment: 500
Sponsor: Assiut University
Location: Egypt
Summary
Limited data have been published on the management and outcome of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) that involves the left main (LM) coronary artery.
Little is known about different strategies and techniques of percutaneous revascularization and long-term outcomes of these patients.
Beside scarcity of data, most studies represent outmoded experience not reflecting contemporary advances in stent technologies, with the introduction of newer generation thinner strut drug eluting stents (DES), bioresorbable polymers, and faster re-endothelization properties promoting vascular healing and endothelial repair.
These advances have significantly reduced the rate of ischemic (especially thrombotic) complications in different cohorts.
Whether these advances would alter the outcome of PCI that involves the LM in patients with ACS is yet to be explored.II. ObjectiveTo explore real-world PCI strategies and techniques in patients with unprotected LM coronary disease presenting with ACSTo explore short- and long-term outcomes of patients of ACS with LM intervention III.
Study endpoints Primary endpoint Major adverse cardiovascular events (MACE) at one year; a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization* *With further extended yearly follow-up to 5 years Secondary endpoints1) All-cause death at one year* 2) Non-fatal MI at one year* 3) Any unplanned revascularization at one year* 4) Target vessel revascularization (TVR) at one year* 5) Academic Research Consortium (ARC) definite/probable stent thrombosis at one year* 6) Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at one year* 7) Contrast induced nephropathy (CIN) defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL within 72 hours after index PCI 8) Echocardiographic left ventricular ejection fraction (LVEF)% [Time Frame: from 6 to 12 months after index PCI]* 9) Angiographic (re)stenosis of the LM [Time Frame: from 6 to 12 months after index PCI] (Optional)
Eligibility Criteria
Inclusion Criteria:Consecutive adult patients admitted with ACS (diagnosed within 72 hours before hospitalization) undergoing revascularization will be screened and considered for inclusion in the study.Patients with ACS (MI or unstable angina) undergoing PCI that involves unprotected LM with a DES will be enrolled; either same-session (during index procedure, with culprit lesion PCI) or scheduled in-hospital (same hospitalization with index PCI).Exclusion Criteria:cannot provide informed consentUn-able/willing to comply with the study requirements including follow up visitsLife expectancy <1 yearContraindications to anti-platelet drugsRescue PCI (PCI after failed thrombolytic therapy)Prior CABG (patent LIMA)Severe CKD (GFR<30 ml/min)
Source: ClinicalTrials.gov (NCT05701319). StuddyBuddy aggregates publicly available trial information.