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

N

National Institute of Cardiology, Warsaw, Poland

Status

Terminated

Conditions

Myocardial Infarction
Cardiovascular Diseases
Heart Failure
Heart Diseases

Treatments

Drug: ACE inhibitors and/or ARB and/or AA
Drug: Platelet inhibitors
Drug: Beta adrenergic blockers
Drug: Statins
Procedure: PCI with stenting

Study type

Interventional

Funder types

Other

Identifiers

NCT00968383
2.50/V/09

Details and patient eligibility

About

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).

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Optimal medical therapy
Active Comparator group
Description:
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
Treatment:
Drug: Statins
Drug: Beta adrenergic blockers
Drug: ACE inhibitors and/or ARB and/or AA
Drug: Platelet inhibitors
PCI with optimal medical therapy
Experimental group
Description:
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
Treatment:
Procedure: PCI with stenting
Drug: Statins
Drug: Beta adrenergic blockers
Drug: ACE inhibitors and/or ARB and/or AA
Drug: Platelet inhibitors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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