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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
PCI
dobutamine stress echocardiography
Sponsored by
Clinical Hospital Center Zemun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, percutaneous coronary intervention, multivessel coronary artery disease, dobutamine stress echocardiography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Military Medical Academy
  • Clinical Hospital Center Zemun
  • Clinical Center Kragujevac
  • Institute for cardiovascular diseases Vojvodine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

complete PCI at initial hospitalization

complete PCI after 30 days

Dobutamine stress testing

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

major adverse cardio-cerebral events
cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2016
Last Updated
June 1, 2023
Sponsor
Clinical Hospital Center Zemun
Collaborators
Institute for cardiovascular diseases Vojvodina, Novi Sad, Serbia, Military Medical Academy, Belgrade, Serbia, Clinical Center Kragujevac, Kragujevac, Serbia
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1. Study Identification

Unique Protocol Identification Number
NCT02756000
Brief Title
Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Center Zemun
Collaborators
Institute for cardiovascular diseases Vojvodina, Novi Sad, Serbia, Military Medical Academy, Belgrade, Serbia, Clinical Center Kragujevac, Kragujevac, Serbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, percutaneous coronary intervention, multivessel coronary artery disease, dobutamine stress echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
complete PCI at initial hospitalization
Arm Type
Experimental
Arm Description
Staged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction
Arm Title
complete PCI after 30 days
Arm Type
Experimental
Arm Description
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
Arm Title
Dobutamine stress testing
Arm Type
Active Comparator
Arm Description
Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography
Intervention Type
Procedure
Intervention Name(s)
PCI
Other Intervention Name(s)
percutaneous coronary intervention
Intervention Description
percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis
Intervention Type
Procedure
Intervention Name(s)
dobutamine stress echocardiography
Intervention Description
Echocardiographic stress test of provoked myocardial ischemia using dobutamine
Primary Outcome Measure Information:
Title
major adverse cardio-cerebral events
Description
cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization
Time Frame
one year
Secondary Outcome Measure Information:
Title
cardiac death
Description
Occurence of death caused by cardiac condition
Time Frame
one year
Title
repeated myocardial infarction
Description
Occurrence of repeated myocardial infarction in the study groups
Time Frame
one year
Title
complications of percutaneous coronary intervention
Description
Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events
Time Frame
one year
Title
stent thrombosis
Description
Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria
Time Frame
two years
Title
hospitalization for heart failure
Description
Occurrence of hospitalization for heart failure in the study groups
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar N Neskovic, MD, PhD
Organizational Affiliation
Clinical Hospital Center Zemun
Official's Role
Study Chair
Facility Information:
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute for cardiovascular diseases Vojvodine
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

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