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

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Beta adrenergic blockers
Platelet inhibitors
Statins
ACE inhibitors and/or ARB and/or AA
PCI with stenting
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Acute Coronary Syndrome, Myocardial infarction, Infarct Related Artery, Percutaneous Coronary Intervention, Medical treatment, Tissue Viability, Magnetic Resonance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Optimal medical therapy

PCI with optimal medical therapy

Arm 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

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

Outcomes

Primary Outcome Measures

change in systolic wall thickening (SWT)

Secondary Outcome Measures

change in left ventricular ejection fraction (LVEF)
change in wall motion score index (WMSI)
change in left ventricular end-diastolic volume (LVEDV)
change in left ventricular end-systolic volume (LVESV)
myocardial tissue characteristics

Full Information

First Posted
June 30, 2009
Last Updated
May 13, 2015
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT00968383
Brief Title
Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated due to low enrollment.
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal medical therapy
Arm Type
Active Comparator
Arm 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
Arm Title
PCI with optimal medical therapy
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Beta adrenergic blockers
Intervention Description
Participants will receive beta adrenergic blockers.
Intervention Type
Drug
Intervention Name(s)
Platelet inhibitors
Intervention Description
Participants will receive platelet inhibitors.
Intervention Type
Drug
Intervention Name(s)
Statins
Intervention Description
Participants will receive statins.
Intervention Type
Drug
Intervention Name(s)
ACE inhibitors and/or ARB and/or AA
Intervention Description
Participants will receive ACE inhibitors and/or ARB and/or AA
Intervention Type
Procedure
Intervention Name(s)
PCI with stenting
Intervention Description
Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.
Primary Outcome Measure Information:
Title
change in systolic wall thickening (SWT)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in left ventricular ejection fraction (LVEF)
Time Frame
6 months
Title
change in wall motion score index (WMSI)
Time Frame
6 months
Title
change in left ventricular end-diastolic volume (LVEDV)
Time Frame
6 months
Title
change in left ventricular end-systolic volume (LVESV)
Time Frame
6 months
Title
myocardial tissue characteristics
Time Frame
3-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz A Malek, M.D. PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariusz Kruk, M.D. PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mariusz Klopotowski, M.D.
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16209957
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. doi: 10.1016/j.ahj.2005.07.002.
Results Reference
background
PubMed Identifier
17105759
Citation
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.
Results Reference
background
PubMed Identifier
19332202
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.
Results Reference
background
PubMed Identifier
11078769
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. doi: 10.1056/NEJM200011163432003.
Results Reference
background
PubMed Identifier
24297771
Citation
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.
Results Reference
derived

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Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment

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