Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

Clinical Hospital Center Zemun120 enrolled

Overview

The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.

This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as \>70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Myocardial Infarction

Interventions

PCIPROCEDURE

percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis

dobutamine stress echocardiographyPROCEDURE

Echocardiographic stress test of provoked myocardial ischemia using dobutamine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical and electrocardiographic signs of first ever ST elevation myocardial infarction (chest pain lasting less than 12 hours with persistent ST elevation of ≥ 1mm in two contiguous leads on ECG recording) * Multivessel coronary artery disease (MVD) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels * Treated with primary PCI of infarct related artery (IRA) only. Exclusion Criteria: * Hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (IABP) implantation and mechanical ventilation prior, during and after primary PCI; * Presence of significant valvular disease; * Decision that patient needs to be treated with coronary artery bypass graft (CABG) and/or valvular replacement or reconstruction surgery after initial culprit only PCI; * Myocardial infarction is caused by stent thrombosis: * Chronic total occlusion of any of the coronary arteries on initial angiogram; * Previously treated by CABG surgery; * Estimated life expectancy less than one year.

Locations (4)

Military Medical Academy

Belgrade, Serbia

Clinical Hospital Center Zemun

Belgrade, Serbia

Clinical Center Kragujevac

Kragujevac, Serbia

Institute for cardiovascular diseases Vojvodine

Novi Sad, Serbia

Outcomes

Primary Outcomes

major adverse cardio-cerebral events

cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization

Time frame: one year

Secondary Outcomes

cardiac death

Occurence of death caused by cardiac condition

Time frame: one year

repeated myocardial infarction

Occurrence of repeated myocardial infarction in the study groups

Time frame: one year

complications of percutaneous coronary intervention

Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events

Time frame: one year

stent thrombosis

Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria

Time frame: two years

hospitalization for heart failure

Occurrence of hospitalization for heart failure in the study groups

Time frame: one year

Data from ClinicalTrials.gov

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