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

This study has been terminated.
(The study was prematurely terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00968383
First received: June 30, 2009
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Heart Failure
Drug: Beta adrenergic blockers
Drug: Platelet inhibitors
Drug: Statins
Drug: ACE inhibitors and/or ARB and/or AA
Procedure: PCI with stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Late Percutaneous Coronary Intervention of the Occluded Infarct-Related Artery in Patients With Preserved Infarct Zone Viability Determined With Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • change in systolic wall thickening (SWT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in left ventricular ejection fraction (LVEF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in wall motion score index (WMSI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in left ventricular end-diastolic volume (LVEDV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in left ventricular end-systolic volume (LVESV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • myocardial tissue characteristics [ Time Frame: 3-5 days ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968383

Locations
Poland
Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT00968383     History of Changes
Other Study ID Numbers: 2.50/V/09
Study First Received: June 30, 2009
Last Updated: November 5, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Acute Coronary Syndrome
Myocardial infarction
Infarct Related Artery
Percutaneous Coronary Intervention
Medical treatment
Tissue Viability
Magnetic Resonance

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Adrenergic Agents
Adrenergic beta-Antagonists
Aldosterone Antagonists
Angiotensin-Converting Enzyme Inhibitors
Platelet Aggregation Inhibitors
Adrenergic Antagonists
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Angiotensin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Hematologic Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents

ClinicalTrials.gov processed this record on April 16, 2014