Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy. (Prague-13)
Primary Purpose
Coronary Artery Stenosis
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
Eligibility Criteria
Inclusion Criteria:
- Patient with acute myocardial infarction with ST segment elevation (STEMI)
- 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:
- Stenosis of the left main of left coronary artery ≥ 50%
- Hemodynamically significant valvular disease
- Patients in cardiogenic shock during STEMI
- Hemodynamic instability
- Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI
Sites / Locations
- Department of Cardioangiology, St. Anne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Complete revascularization
Conservative management
Arm Description
Percutaneous coronary intervention of "non-infarct" coronary arteries
standard guideline-based medical therapy
Outcomes
Primary Outcome Measures
composite endpoint of death, nonfatal acute myocardial infarction and stroke
Secondary Outcome Measures
cardiovascular death
recurrent myocardial infarction
target vessel failure
progression of studied stenosis of non-culprit artery
stroke
hospitalization for heart failure
changes of left ventricular ejection fraction
hospitalization for unstable angina pectoris
outcomes of questionnaire regarding angina pectoris
target vessel revascularization
non infarct artery
target lesion revascularization
non infarct artery
Full Information
NCT ID
NCT01332591
First Posted
March 30, 2011
Last Updated
December 31, 2014
Sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborators
Bulgarian Cardiac Institute, Tomas Bata Hospital, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT01332591
Brief Title
Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
Acronym
Prague-13
Official Title
Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborators
Bulgarian Cardiac Institute, Tomas Bata Hospital, Czech Republic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI 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.
Detailed Description
Introduction:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Complete revascularization
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention of "non-infarct" coronary arteries
Arm Title
Conservative management
Arm Type
No Intervention
Arm Description
standard guideline-based medical therapy
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
PCI of significant stenoses of "non-infarct" coronary arteries
Primary Outcome Measure Information:
Title
composite endpoint of death, nonfatal acute myocardial infarction and stroke
Time Frame
2 years
Secondary Outcome Measure Information:
Title
cardiovascular death
Time Frame
2 years
Title
recurrent myocardial infarction
Time Frame
2 years
Title
target vessel failure
Description
progression of studied stenosis of non-culprit artery
Time Frame
2 years
Title
stroke
Time Frame
2 years
Title
hospitalization for heart failure
Time Frame
2 years
Title
changes of left ventricular ejection fraction
Time Frame
2 years
Title
hospitalization for unstable angina pectoris
Time Frame
2 years
Title
outcomes of questionnaire regarding angina pectoris
Time Frame
2 years
Title
target vessel revascularization
Description
non infarct artery
Time Frame
2 years
Title
target lesion revascularization
Description
non infarct artery
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with acute myocardial infarction with ST segment elevation (STEMI)
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:
Stenosis of the left main of left coronary artery ≥ 50%
Hemodynamically significant valvular disease
Patients in cardiogenic shock during STEMI
Hemodynamic instability
Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ota Hlinomaz, MD, PhD
Organizational Affiliation
+420604273627
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardioangiology, St. Anne University Hospital
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
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