Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment

Heart Failure Clinical Trial

— COAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00968383
• Other study ID #: 2.50/V/09
• Status: Terminated
• Phase: N/A
• First received: June 30, 2009
• Last updated: May 13, 2015
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
• Platelet inhibitors
Participants will receive platelet inhibitors.
• Statins
Participants will receive statins.
• 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.

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in systolic wall thickening (SWT)		6 months	No
Secondary	change in left ventricular ejection fraction (LVEF)		6 months	No
Secondary	change in wall motion score index (WMSI)		6 months	No
Secondary	change in left ventricular end-diastolic volume (LVEDV)		6 months	No
Secondary	change in left ventricular end-systolic volume (LVESV)		6 months	No
Secondary	myocardial tissue characteristics		3-5 days	Yes