NCT02756000

Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Clinical Hospital Center Zemun · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	PCI	percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis
PROCEDURE	dobutamine stress echocardiography	Echocardiographic stress test of provoked myocardial ischemia using dobutamine

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-04-29
• Last updated: 2023-06-02

Locations

4 sites across 1 country: Serbia