Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack

Phase 4

Completed

• Conditions: Coronary Disease; Heart Diseases; Myocardial Infarction; Cardiovascular Diseases
• Interventions: Behavioral: Optimal Medical Therapy; Device: PCI with stenting

• Registration Number: NCT00025766
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to evaluate arterial patency and left ventricular ejection fraction by examining angiographic data one year following a heart attack and treatment with late revascularization.

Detailed Description

BACKGROUND:

The Occluded Artery Trial (OAT) is an international study with 3200 participants. Its goal is to determine if delayed mechanical reperfusion by means of percutaneous transluminal coronary angioplasty (PTCA) and stenting reduces death, heart attacks, and hospitalization in individuals with New York Heart Association (NYHA) Class IV heart failure and a persistently occluded infarct-related artery (IRA) 3 to 28 days following a heart attack. While left ventricular (LV) function improvement has been suggested as a benefit of late reperfusion, solid evidence to support this claim is lacking. Furthermore, while stenting has reduced reocclusion rates after total occlusion PTCA, the reocclusion rate after a recent heart attack is unknown.

DESIGN NARRATIVE:

This study is a substudy of OAT and will enroll 380 participants. The primary aims of the study include the following: 1) to compare long-term patency rates between the two treatment groups (conventional medical therapy or PTCA and stenting) by means of follow-up coronary angiography one year after enrollment; and 2) to compare the change in global LV ejection fraction between the two treatment groups utilizing baseline and follow-up contrast LV angiograms. Secondary aims include the following: 1) comparison of regional wall motion and LV volumes; 2) study of the effect of reocclusion and spontaneous recanalization on LV function; and 3) study of the effect of duration of occlusion on changes in LV function after Percutaneous Coronary Intervention (PCI). The substudy will be conducted at 21 OAT study sites. The Substudy Coordinating Center (SCC) is at the University of Alberta in Edmonton, Canada. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute, which is the DCC for the OAT study. The Angiographic Core Laboratory is at the University of British Columbia.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2001-10-22
• Study First Submitted QC: 2001-10-22
• Study First Posted: 2001-10-23
• Primary Completion: 2006-04
• Study Completion: 2011-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Has experienced a heart attack 3 to 28 days prior to study entry
• Has a persistently occluded IRA

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Optimal Medical Therapy	Optimal medical therapy alone without PCI of the occluded culprit artery
1	PCI with stenting	PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy
1	Optimal Medical Therapy	PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy

Primary Outcome Measures

Name	Time	Method
LV ejection fraction	1 year
Infarct-related artery patency (measured by contrast LV and coronary angiography)	1 year

Secondary Outcome Measures

Name	Time	Method
Effect of reocclusion and spontaneous recanalization on LV function	1 year
Comparison of regional wall motion and LV volumes	1 year
Effect of duration of occlusion on changes in LV function after PCI	1 year

Trial Locations

Locations (1)

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada