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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by St. Anne's University Hospital Brno, Czech Republic.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Staged Treatment of Significant Stenosis of Non Infarct Coronary Arteries
Procedure: Percutaneous coronary intervention or coronary artery bypass grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial

Resource links provided by NLM:


Further study details as provided by St. Anne's University Hospital Brno, Czech Republic:

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

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: May 2009
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Complete revascularization
Complete revascularization of significant stenoses of "non-infarct" coronary arteries (PCI or CABG; 3rd-40th day after primary PCI)
Procedure: Percutaneous coronary intervention or coronary artery bypass grafting
PCI or CABG of significant stenoses of "non-infarct" coronary arteries
No Intervention: Conservative management
standard guideline-based medical therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332591

Contacts
Contact: Ota Hlinomaz, MD, PhD +420604273627 ota.hlinomaz@fnusa.cz

Locations
Czech Republic
Department of Cardioangiology, St. Anne University Hospital Recruiting
Brno, Czech Republic, 65691
Contact: Ota Hlinomaz    +420604273627    ota.hlinomaz@fnusa.cz   
Principal Investigator: Ota Hlinomaz, MD, PhD         
Sub-Investigator: Ladislav Groch, MD, PhD         
Sponsors and Collaborators
St. Anne's University Hospital Brno, Czech Republic
Bulgarian Cardiac Institute, Sofia, Bulgaria
Bata Hospital, Zlin, Czech Republic
  More Information

No publications provided

Responsible Party: Ota Hlinomaz, MD, PhD, St. Anne Univerity Hospital, Brno, Czech Republic
ClinicalTrials.gov Identifier: NCT01332591     History of Changes
Other Study ID Numbers: NT11412
Study First Received: March 30, 2011
Last Updated: April 1, 2011
Health Authority: Czech Republic: Ethics Committee

Keywords provided by St. Anne's University Hospital Brno, Czech Republic:
STEMI, primary PCI, non-infarct, non-culprit lesion, CABG

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 23, 2014