Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes (LIMACS)

February 21, 2023 updated by: Salma Taha, Assiut University

Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes The LIMACS Multicenter Registry

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

IV. Study Type Single-arm, prospective and retrospective, multicenter, open-label registry V. Study Population 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 consent
  • Un-able/willing to comply with the study requirements including follow up visits
  • Life expectancy <1 year
  • Contraindications to anti-platelet drugs
  • Rescue PCI (PCI after failed thrombolytic therapy)
  • Prior CABG (patent LIMA)
  • Severe CKD (GFR<30 ml/min) VI. Study Treatment Eligible patients will receive ASA as per standard of care and ticagrelor/clopidogrel loading dose according to recent guidelines.

In patients with multivessel disease, treatment only of the culprit lesion/target vessel during index PCI is recommended. Clinical follow up (clinic visit/phone call) will be scheduled at 1, 6, 12, and 60 months. Control invasive coronary angiography at 6-12 months after index PCI will be encouraged. Echocardiographic evaluation of LVEF is recommended at 6 and 12 month-follow up.

VII. Study Duration Enrollment Duration: 24 months Follow up duration: Five years (predefined follow up scheduled at 1, 6, 12, and 60 months). Annual follow up between 12 and 60 months are encouraged but not mandated.

VIII. Estimated Enrollment 500 patients

Sample Size Calculation: As this is a single-arm registry, sample size calculation is not mandatory. However, a sample size of 450 subjects would be required according to the following assumptions:

Expected event rate: 3.0%, test significance level (alpha): 2.5% (1-sided), sample size: 400, power: 80%, expected drop out/protocol violation: 10%, final sample size: 450.

IX. Prespecified Subgroup Analyses

  1. One vs. two-stent LM-bifurcation technique
  2. LM culprit vs. non-culprit intervention
  3. Multivessel vs. single-vessel disease
  4. Complete vs. incomplete revascularization
  5. Diabetes mellitus (yes/no)

  6. STEMI: primary vs. scheduled pharmaco-invasive PCI X. Projected Study Timelines

    • First patient enrollment: January 2023
    • Last patient enrollment: December 2024
    • First 12-month FUP: January 2024
    • Last 12-month FUP: December 2025 (1ry endpoint completion)
    • Final 5-year FUP: December 2028 (Study conclusion)

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university
        • Contact:
        • Principal Investigator:
          • Salma Taha, Ass.Prof
      • Cairo, Egypt
        • AlAzhar university
        • Contact:
        • Principal Investigator:
          • Mohammad Abdelghani, lecturer
      • Tanta, Egypt
        • Tanta University
        • Contact:
          • Osama Shoaib, lecturer
        • Principal Investigator:
          • Osama Shoaib, lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patients with ACS and LM disease

Description

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 consent
  • Un-able/willing to comply with the study requirements including follow up visits
  • Life expectancy <1 year
  • Contraindications to anti-platelet drugs
  • Rescue PCI (PCI after failed thrombolytic therapy)
  • Prior CABG (patent LIMA)
  • Severe CKD (GFR<30 ml/min)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: one year
a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization*
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: one year
death due to any cause
one year
Non-fatal MI
Time Frame: one year
Myocardial infarction
one year
Any unplanned revascularization
Time Frame: one year
revascularization
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Al-Azhar University
Tanta University
Egyptian Soceity of Cardiology

Investigators

  • Principal Investigator: Osama Shoaib, lecturer, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM in ACS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

through google drive

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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