Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes

NCT05701319 | Unknown DMC

• 1 other identifier: LM in ACS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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

Conditions

LMN Disease

Keywords

UPLM; ACS; PPCI

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization\*

  one year

Secondary Outcomes (3)

• All-cause death

  one year

• Non-fatal MI

  one year

• Any unplanned revascularization

  one year

Interventions

PCI PROCEDURE

percutaneous coronary intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients with ACS and LM disease

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead
• Tanta University: collaborator
• Al-Azhar University: collaborator
• Egyptian Soceity of Cardiology: collaborator

Study Sites (3)

Assiut University

Asyut, 71515, Egypt

Location

Alazhar university

Cairo, Egypt

Location

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Osama Shoaib, lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma Taha, Ass.Prof

CONTACT

+201003329108; esmaeil.salma@aun.edu.eg

Mohammad Abdelghani, lecturer

CONTACT

m.abdelghani.nl@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Professor of Cardiology

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

EG (3)