Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
NCT ID: NCT01332591
Last Updated: 2015-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
213 participants
INTERVENTIONAL
2008-09-30
2014-12-31
Brief Summary
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Detailed Description
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Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.
Aim of study:
The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
Hypothesis:
Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Complete revascularization
Percutaneous coronary intervention of "non-infarct" coronary arteries
Percutaneous coronary intervention
PCI of significant stenoses of "non-infarct" coronary arteries
Conservative management
standard guideline-based medical therapy
No interventions assigned to this group
Interventions
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Percutaneous coronary intervention
PCI of significant stenoses of "non-infarct" coronary arteries
Eligibility Criteria
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Inclusion Criteria
* Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
* One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
* Enrollment ≥48 hours following onset of symptoms
Exclusion Criteria
* Hemodynamically significant valvular disease
* Patients in cardiogenic shock during STEMI
* Hemodynamic instability
* Angina pectoris \> grade 2 CCS lasting 1 month prior to STEMI
18 Years
ALL
No
Sponsors
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Bulgarian Cardiac Institute
NETWORK
Tomas Bata Hospital, Czech Republic
OTHER
St. Anne's University Hospital Brno, Czech Republic
OTHER
Responsible Party
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Ota Hlinomaz, MD, PhD
Ota Hlinomaz, MD, PhD
Principal Investigators
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Ota Hlinomaz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
+420604273627
Locations
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Department of Cardioangiology, St. Anne University Hospital
Brno, , Czechia
Countries
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Other Identifiers
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NT11412
Identifier Type: -
Identifier Source: org_study_id
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