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Completed

NCT Number: NCT01332591

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardioangiology, St. Anne University Hospital

Brno, 65691, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

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

Primary outcomes

  1. composite endpoint of death, nonfatal acute myocardial infarction and stroke

    Time frame: 2 years

Secondary outcomes

  1. cardiovascular death

    Time frame: 2 years

  2. recurrent myocardial infarction

    Time frame: 2 years

  3. target vessel failure

    Time frame: 2 years

    progression of studied stenosis of non-culprit artery

  4. stroke

    Time frame: 2 years

  5. hospitalization for heart failure

    Time frame: 2 years

  6. changes of left ventricular ejection fraction

    Time frame: 2 years

  7. hospitalization for unstable angina pectoris

    Time frame: 2 years

  8. outcomes of questionnaire regarding angina pectoris

    Time frame: 2 years

  9. target vessel revascularization

    Time frame: 2 years

    non infarct artery

  10. target lesion revascularization

    Time frame: 2 years

    non infarct artery

Sponsors and collaborators

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Other

Collaborators

  • Bulgarian Cardiac Institute
  • Tomas Bata Hospital, Czech Republic

Registry information

Official study title

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

Acronym: Prague-13

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2011
Registry last updated
Jan 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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