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

This study has been completed.
Sponsor:
Collaborators:
Bulgarian Cardiac Institute, Sofia, Bulgaria
Bata Hospital, Zlin, Czech Republic
Information provided by (Responsible Party):
Ota Hlinomaz, MD, PhD, St. Anne's University Hospital Brno, Czech Republic
ClinicalTrials.gov Identifier:
NCT01332591
First received: March 30, 2011
Last updated: December 31, 2014
Last verified: December 2014
  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
Coronary Artery Stenosis
Procedure: Percutaneous coronary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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


Enrollment: 213
Study Start Date: September 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Complete revascularization
Percutaneous coronary intervention of "non-infarct" coronary arteries
Procedure: Percutaneous coronary intervention
PCI of significant stenoses of "non-infarct" coronary arteries
No Intervention: Conservative management
standard guideline-based medical therapy

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.

  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

Locations
Czech Republic
Department of Cardioangiology, St. Anne University Hospital
Brno, Czech Republic, 65691
Sponsors and Collaborators
St. Anne's University Hospital Brno, Czech Republic
Bulgarian Cardiac Institute, Sofia, Bulgaria
Bata Hospital, Zlin, Czech Republic
Investigators
Principal Investigator: Ota Hlinomaz, MD, PhD +420604273627
  More Information

No publications provided

Responsible Party: Ota Hlinomaz, MD, PhD, St. Anne's University Hospital Brno, Czech Republic
ClinicalTrials.gov Identifier: NCT01332591     History of Changes
Other Study ID Numbers: NT11412
Study First Received: March 30, 2011
Last Updated: December 31, 2014
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 Stenosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on August 31, 2015