Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. (Prague-13)

This study is currently recruiting participants.

Verified October 2010 by St. Anne's University Hospital Brno, Czech Republic

Sponsor:

Collaborators:

Bulgarian Cardiac Institute, Sofia, Bulgaria

Bata Hospital, Zlin, Czech Republic

Information provided by:

St. Anne's University Hospital Brno, Czech Republic

ClinicalTrials.gov Identifier:

NCT01332591

First received: March 30, 2011

Last updated: April 1, 2011

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2011

Last Updated Date

April 1, 2011

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

composite endpoint of death, nonfatal acute myocardial infarction and stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01332591 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

cardiovascular death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
recurrent myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
target vessel failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
progression of studied stenosis of non-culprit artery
stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]
hospitalization for heart failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
changes of left ventricular ejection fraction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
hospitalization for unstable angina pectoris [ Time Frame: 2 years ] [ Designated as safety issue: No ]
outcomes of questionnaire regarding angina pectoris [ Time Frame: 2 years ] [ Designated as safety issue: No ]
target vessel revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
non infarct artery
target lesion revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
non infarct artery

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy.

Official Title ^ICMJE

Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Staged Treatment of Significant Stenosis of Non Infarct Coronary Arteries

Intervention ^ICMJE

Procedure: Percutaneous coronary intervention or coronary artery bypass grafting

PCI or CABG of significant stenoses of "non-infarct" coronary arteries

Study Arm (s)

Active Comparator: Complete revascularization
Complete revascularization of significant stenoses of "non-infarct" coronary arteries (PCI or CABG; 3rd-40th day after primary PCI)

Intervention: Procedure: Percutaneous coronary intervention or coronary artery bypass grafting
No Intervention: Conservative management
standard guideline-based medical therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Not Provided

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ota Hlinomaz, MD, PhD

+420604273627

ota.hlinomaz@fnusa.cz

Location Countries ^ICMJE

Czech Republic

Administrative Information

NCT Number ^ICMJE

NCT01332591

Other Study ID Numbers ^ICMJE

NT11412

Has Data Monitoring Committee

Not Provided

Responsible Party

Ota Hlinomaz, MD, PhD, St. Anne Univerity Hospital, Brno, Czech Republic

Study Sponsor ^ICMJE

St. Anne's University Hospital Brno, Czech Republic

Collaborators ^ICMJE

Bulgarian Cardiac Institute, Sofia, Bulgaria
Bata Hospital, Zlin, Czech Republic

Investigators ^ICMJE

Not Provided

Information Provided By

St. Anne's University Hospital Brno, Czech Republic

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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