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
1 other identifier
interventional
120
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJune 2, 2023
June 1, 2023
2.8 years
April 28, 2016
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
major adverse cardio-cerebral events
cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization
one year
Secondary Outcomes (5)
cardiac death
one year
repeated myocardial infarction
one year
complications of percutaneous coronary intervention
one year
stent thrombosis
two years
hospitalization for heart failure
one year
Study Arms (3)
complete PCI at initial hospitalization
EXPERIMENTALStaged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction
complete PCI after 30 days
EXPERIMENTALStaged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction
Dobutamine stress testing
ACTIVE COMPARATORRevascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography
Interventions
percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis
Echocardiographic stress test of provoked myocardial ischemia using dobutamine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Hospital Center Zemun
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Institute for cardiovascular diseases Vojvodine
Novi Sad, 21000, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aleksandar N Neskovic, MD, PhD
Clinical Hospital Center Zemun
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of interventional cardiology diagnostics
Study Record Dates
First Submitted
April 28, 2016
First Posted
April 29, 2016
Study Start
January 1, 2016
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
June 2, 2023
Record last verified: 2023-06