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

Coronary Artery Stenosis Clinical Trial

— Prague-13  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332591
• Other study ID #: NT11412
• Status: Completed
• Phase: N/A
• First received: March 30, 2011
• Last updated: December 31, 2014
• Start date: September 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: St. Anne's University Hospital Brno, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Procedure:
• Percutaneous coronary intervention
PCI of significant stenoses of "non-infarct" coronary arteries

Locations

Country	Name	City	State
Czech Republic	Department of Cardioangiology, St. Anne University Hospital	Brno

Sponsors (3)

Lead Sponsor	Collaborator
St. Anne's University Hospital Brno, Czech Republic	Bata Hospital, Zlin, Czech Republic, Bulgarian Cardiac Institute, Sofia, Bulgaria

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite endpoint of death, nonfatal acute myocardial infarction and stroke		2 years	No
Secondary	cardiovascular death		2 years	No
Secondary	recurrent myocardial infarction		2 years	No
Secondary	target vessel failure	progression of studied stenosis of non-culprit artery	2 years	No
Secondary	stroke		2 years	No
Secondary	hospitalization for heart failure		2 years	No
Secondary	changes of left ventricular ejection fraction		2 years	No
Secondary	hospitalization for unstable angina pectoris		2 years	No
Secondary	outcomes of questionnaire regarding angina pectoris		2 years	No
Secondary	target vessel revascularization	non infarct artery	2 years	No
Secondary	target lesion revascularization	non infarct artery	2 years	No