Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment

NCT00968383 | Terminated

• 1 other identifier: 2.50/V/09
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Heart Failure

Keywords

Acute Coronary Syndrome; Myocardial infarction; Infarct Related Artery; Percutaneous Coronary Intervention; Medical treatment; Tissue Viability; Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

• change in systolic wall thickening (SWT)

  6 months

Secondary Outcomes (5)

• change in left ventricular ejection fraction (LVEF)

  6 months

• change in wall motion score index (WMSI)

  6 months

• change in left ventricular end-diastolic volume (LVEDV)

  6 months

• change in left ventricular end-systolic volume (LVESV)

  6 months

• myocardial tissue characteristics

  3-5 days

Study Arms (2)

Optimal medical therapy

ACTIVE COMPARATOR

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; Drug: Platelet inhibitors; Drug: Statins; Drug: ACE inhibitors and/or ARB and/or AA

PCI with optimal medical therapy

EXPERIMENTAL

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; Drug: Platelet inhibitors; Drug: Statins; Drug: ACE inhibitors and/or ARB and/or AA; Procedure: PCI with stenting

Interventions

Beta adrenergic blockers DRUG

Participants will receive beta adrenergic blockers.

Optimal medical therapy; PCI with optimal medical therapy

Platelet inhibitors DRUG

Participants will receive platelet inhibitors.

Optimal medical therapy; PCI with optimal medical therapy

Statins DRUG

Participants will receive statins.

Optimal medical therapy; PCI with optimal medical therapy

ACE inhibitors and/or ARB and/or AA DRUG

Participants will receive ACE inhibitors and/or ARB and/or AA

Optimal medical therapy; PCI with optimal medical therapy

PCI with stenting PROCEDURE

Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.

PCI with optimal medical therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Unstable clinical condition

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (5)

• 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. doi: 10.1016/j.ahj.2005.07.002.

  PMID: 16209957 BACKGROUND

• 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. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.

  PMID: 17105759 BACKGROUND

• 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. doi: 10.1016/j.ahj.2008.12.008.

  PMID: 19332202 BACKGROUND

• 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. doi: 10.1056/NEJM200011163432003.

  PMID: 11078769 BACKGROUND

• Malek LA, Silva JC, Bellenger NG, Nicolau JC, Klopotowski M, Spiewak M, Rassi CH, Lewandowski Z, Kruk M, Rochitte CE, Ruzyllo W, Witkowski A. Late percutaneous coronary intervention for an occluded infarct-related artery in patients with preserved infarct zone viability: a pooled analysis of cardiovascular magnetic resonance studies. Cardiol J. 2013;20(5):552-9. doi: 10.5603/CJ.2013.0141.

  PMID: 24297771 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Heart Failure; Acute Coronary Syndrome

Interventions

Adrenergic beta-Antagonists; Platelet Aggregation Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Hematologic Agents; Therapeutic Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Enzyme Inhibitors; Lipid Regulating Agents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Lukasz A Malek, M.D. PhD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Mariusz Kruk, M.D. PhD

  National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

• Mariusz Klopotowski, M.D.

  National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: August 31, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

PL (1)