Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment - Full Text View

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:

MedlinePlus related topics: Blood Thinners Heart Attack Heart Diseases Heart Failure MRI Scans Statins

U.S. FDA Resources

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.

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:

Hochman JS, Lamas GA, Knatterud GL, Buller CE, Dzavik V, Mark DB, Reynolds HR, White HD; Occluded Artery Trial Research Group. Design and methodology of the Occluded Artery Trial (OAT). Am Heart J. 2005 Oct;150(4):627-42.

Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. Epub 2006 Nov 14.

Malek LA, Reynolds HR, Forman SA, Vozzi C, Mancini GB, French JK, Dziarmaga M, Renkin JP, Kochman J, Lamas GA, Hochman JS. Late coronary intervention for totally occluded left anterior descending coronary arteries in stable patients after myocardial infarction: Results from the Occluded Artery Trial (OAT). Am Heart J. 2009 Apr;157(4):724-32.

Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53.

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 May 21, 2013

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