Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

NCT ID: NCT02756000

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

complete PCI at initial hospitalization

Staged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction

Group Type: EXPERIMENTAL

PCI

Intervention Type: PROCEDURE

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

complete PCI after 30 days

Staged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction

Group Type: EXPERIMENTAL

PCI

Intervention Type: PROCEDURE

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

Dobutamine stress testing

Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography

Group Type: ACTIVE_COMPARATOR

PCI

Intervention Type: PROCEDURE

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

dobutamine stress echocardiography

Intervention Type: PROCEDURE

Echocardiographic stress test of provoked myocardial ischemia using dobutamine

Interventions

PCI

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

Intervention Type: PROCEDURE

dobutamine stress echocardiography

Echocardiographic stress test of provoked myocardial ischemia using dobutamine

Intervention Type: PROCEDURE

Other Intervention Names

percutaneous coronary intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Cardiovascular Diseases, Vojvodina

OTHER

Sponsor Role: collaborator

Military Medical Academy, Belgrade, Serbia

OTHER

Sponsor Role: collaborator

Clinical Center Kragujevac, Kragujevac, Serbia

UNKNOWN

Sponsor Role: collaborator

Clinical Hospital Center Zemun

OTHER

Sponsor Role: lead

Responsible Party

Ivan Ilic

Head of interventional cardiology diagnostics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleksandar N Neskovic, MD, PhD

Role: STUDY_CHAIR

Clinical Hospital Center Zemun

Locations

Military Medical Academy

Belgrade, , Serbia

Clinical Hospital Center Zemun

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Institute for cardiovascular diseases Vojvodine

Novi Sad, , Serbia

Countries

Serbia

Other Identifiers

ZEM-CARD-003

Identifier Type: -

Identifier Source: org_study_id