Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI (MVD)

Appropriate Timing of Complete Revascularization for Multivessel Coronary Artery Disease After Culprit Only Primary Percutaneous Coronary Intervention (PCI) for ST Elevation Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: PCI; Procedure: dobutamine stress echocardiography

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Zemun
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Novi Sad, Serbia, 21000
    • Institute for cardiovascular diseases Vojvodine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: PCI; percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis; Other Names: percutaneous coronary intervention
Experimental: 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	Procedure: PCI; percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis; Other Names: percutaneous coronary intervention
Active Comparator: Dobutamine stress testing; Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography	Procedure: PCI; percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis; Other Names: percutaneous coronary intervention; Procedure: dobutamine stress echocardiography; Echocardiographic stress test of provoked myocardial ischemia using dobutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardio-cerebral events	cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac death	Occurence of death caused by cardiac condition	one year
repeated myocardial infarction	Occurrence of repeated myocardial infarction in the study groups	one year
complications of percutaneous coronary intervention	Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events	one year
stent thrombosis	Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria	two years
hospitalization for heart failure	Occurrence of hospitalization for heart failure in the study groups	one year

Collaborators and Investigators

• Sponsor: Clinical Hospital Center Zemun
• Collaborators: Military Medical Academy, Belgrade, Serbia; Institute for cardiovascular diseases Vojvodina, Novi Sad, Serbia; Clinical Center Kragujevac, Kragujevac, Serbia
• Investigators: Study Chair: Aleksandar N Neskovic, MD, PhD, Clinical Hospital Center Zemun

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimated): April 29, 2016

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; myocardial infarction; dobutamine stress echocardiography; multivessel coronary artery disease
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: ZEM-CARD-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED