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

NCT01332591 | Completed DMC

• 1 other identifier: NT11412
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Stenosis

Keywords

STEMI, primary PCI, non-infarct, non-culprit lesion, CABG

Outcome Measures

Primary Outcomes (1)

• composite endpoint of death, nonfatal acute myocardial infarction and stroke

  2 years

Secondary Outcomes (10)

• cardiovascular death

  2 years

• recurrent myocardial infarction

  2 years

• target vessel failure

  2 years

• stroke

  2 years

• hospitalization for heart failure

  2 years

Study Arms (2)

Complete revascularization

ACTIVE COMPARATOR

Percutaneous coronary intervention of "non-infarct" coronary arteries

Procedure: Percutaneous coronary intervention

Conservative management

NO INTERVENTION

standard guideline-based medical therapy

Interventions

Percutaneous coronary intervention PROCEDURE

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

Complete revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Bulgarian Cardiac Institute: collaborator
• Tomas Bata Hospital, Czech Republic: collaborator

Study Sites (1)

Department of Cardioangiology, St. Anne University Hospital

Brno, 65691, Czechia

Location

MeSH Terms

Conditions

Coronary Stenosis; ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Ota Hlinomaz, MD, PhD

  +420604273627

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ota Hlinomaz, MD, PhD

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 11, 2011
• Study Start: September 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 1, 2015

Record last verified: 2014-12

Locations

CZ (1)