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OpenTrials
Completed

NCT Number: NCT02756000

Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital Center Zemun, Belgrade, Serbia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCI

Procedure

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

Other names: percutaneous coronary intervention

dobutamine stress echocardiography

Procedure

Echocardiographic stress test of provoked myocardial ischemia using dobutamine

Primary outcomes

  1. major adverse cardio-cerebral events

    Time frame: one year

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

Secondary outcomes

  1. cardiac death

    Time frame: one year

    Occurence of death caused by cardiac condition

  2. repeated myocardial infarction

    Time frame: one year

    Occurrence of repeated myocardial infarction in the study groups

  3. complications of percutaneous coronary intervention

    Time frame: one year

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

  4. stent thrombosis

    Time frame: two years

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

  5. hospitalization for heart failure

    Time frame: one year

    Occurrence of hospitalization for heart failure in the study groups

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Zemun

Other

Collaborators

  • Clinical Center Kragujevac
  • Institute of Cardiovascular Diseases, Vojvodina
  • Military Medical Academy, Belgrade, Serbia

Registry information

Official study title

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

Acronym: MVD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2016
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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