Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

Myocardial Infarction Clinical Trial

— MVD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756000
• Other study ID #: ZEM-CARD-003
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 2018

Study information

• Verified date: June 2023
• Source: Clinical Hospital Center Zemun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• PCI
percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis
• dobutamine stress echocardiography
Echocardiographic stress test of provoked myocardial ischemia using dobutamine

Locations

Country	Name	City	State
Serbia	Clinical Hospital Center Zemun	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Institute for cardiovascular diseases Vojvodine	Novi Sad

Sponsors (4)

Lead Sponsor	Collaborator
Clinical Hospital Center Zemun	Clinical Center Kragujevac, Kragujevac, Serbia, Institute for cardiovascular diseases Vojvodina, Novi Sad, Serbia, Military Medical Academy, Belgrade, Serbia

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardio-cerebral events	cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization	one year
Secondary	cardiac death	Occurence of death caused by cardiac condition	one year
Secondary	repeated myocardial infarction	Occurrence of repeated myocardial infarction in the study groups	one year
Secondary	complications of percutaneous coronary intervention	Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events	one year
Secondary	stent thrombosis	Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria	two years
Secondary	hospitalization for heart failure	Occurrence of hospitalization for heart failure in the study groups	one year