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Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes

NCT05701319 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-02-23

No results posted yet for this study

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. Objective

1. To explore real-world PCI strategies and techniques in patients with unprotected LM coronary disease presenting with ACS
2. To 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 endpoints

1\) 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)

Conditions

  • LMN Disease

Interventions

PROCEDURE

PCI

percutaneous coronary intervention

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Al-Azhar University

    collaborator OTHER

  • Egyptian Soceity of Cardiology

    collaborator UNKNOWN

  • Assiut University

    lead OTHER

Principal Investigators

  • Osama Shoaib, lecturer · Tanta University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-01-31
Completion
2025-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701319 on ClinicalTrials.gov