Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment (COAT)

May 13, 2015 updated by: Institute of Cardiology, Warsaw, Poland

Late Percutaneous Coronary Intervention of the Occluded Infarct-Related Artery in Patients With Preserved Infarct Zone Viability Determined With Magnetic Resonance Imaging

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients with preserved infarct zone viability improves left ventricular systolic function and volumes at 6 months follow-up. The secondary purpose is to assess the changes in myocardial tissue characteristics after late percutaneous coronary intervention (PCI).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Rapid restoration of blood flow in the infarct-related artery (IRA), one of the cornerstones of contemporary treatment of acute myocardial infarction (MI) prevents myocardial necrosis and its consequences. However, due to late presentation or failed fibrinolytic therapy up to one third of patients have persistently occluded IRA after MI.

Recently, the Occluded Artery Trial (OAT) has demonstrated that percutaneous coronary intervention (PCI) with optimal medical therapy does not reduce the frequency of major adverse events compared to optimal medical therapy alone when performed on days 3-28 post MI in stable patients. Assessment of infarct zone viability was not used as an inclusion/exclusion criterion in the main OAT trial.

Several studies confirm that patients with left ventricular systolic dysfunction and preserved myocardial viability (necrosis transmurality<50% in most segments of the infarct zone) assessed with magnetic resonance imaging benefit from revascularization.

Late opening of the occluded infarct-related artery only in patients with preserved myocardial tissue viability may lead to improvement of left ventricular volumes and function.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrollment 3-28 days after an acute myocardial infarction.
  • Infarct related artery occlusion (TIMI 0 or 1).
  • High risk: left ventricular ejection fraction (LVEF)<50% or LVEF>50% and proximal coronary occlusion.
  • Preserved infarct zone viability (necrosis transmurality <50% in at least 4 segments out of 17 according to AHA classification).

Exclusion Criteria:

  • Unstable clinical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Optimal medical therapy
Conventional medical management, including aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) and/or aldosterone antagonist and risk factor modification
Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Drug: Statins
Participants will receive statins.
Drug: ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
Experimental: PCI with optimal medical therapy
Conventional medical management, including aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) and/or aldosterone antagonist and risk factor modification plus percutaneous coronary intervention and coronary stenting
Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Drug: Statins
Participants will receive statins.
Drug: ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
Procedure: PCI with stenting
Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in systolic wall thickening (SWT)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in left ventricular ejection fraction (LVEF)
Time Frame: 6 months
6 months
change in wall motion score index (WMSI)
Time Frame: 6 months
6 months
change in left ventricular end-diastolic volume (LVEDV)
Time Frame: 6 months
6 months
change in left ventricular end-systolic volume (LVESV)
Time Frame: 6 months
6 months
myocardial tissue characteristics
Time Frame: 3-5 days
3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Investigators

  • Principal Investigator: Lukasz A Malek, M.D. PhD, Institute of Cardiology, Warsaw, Poland
  • Study Chair: Mariusz Kruk, M.D. PhD, Institute of Cardiology, Warsaw, Poland
  • Study Chair: Mariusz Klopotowski, M.D., Institute of Cardiology, Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.50/V/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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