Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack (TOSCA-2)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction |
Device: PCI with stenting Behavioral: Optimal Medical Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TOSCA-2: An Angiographic Substudy (Ancillary) of the Occluded Artery Trial (OAT) |
- LV ejection fraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Infarct-related artery patency (measured by contrast LV and coronary angiography) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Comparison of regional wall motion and LV volumes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Effect of reocclusion and spontaneous recanalization on LV function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Effect of duration of occlusion on changes in LV function after PCI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 380 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy
|
Device: PCI with stenting
PCI with stenting of the occluded culprit infarct-related artery
Behavioral: Optimal Medical Therapy
Participants will receive optimal medical therapy.
|
|
Active Comparator: 2
Optimal medical therapy alone without PCI of the occluded culprit artery
|
Behavioral: Optimal Medical Therapy
Participants will receive optimal medical therapy.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Has experienced a heart attack 3 to 28 days prior to study entry
- Has a persistently occluded IRA
Contacts and Locations| Canada, Ontario | |
| University Health Network - Toronto General Hospital | |
| Toronto, Ontario, Canada | |
| Study Chair: | Vladimir Dzavik, MD | University Health Network - Toronto General Hospital |
More Information
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Vladimir Dzavik, University Health Network, Toronto, ON, Canada |
| ClinicalTrials.gov Identifier: | NCT00025766 History of Changes |
| Other Study ID Numbers: | 989, R01 HL67683 |
| Study First Received: | October 22, 2001 |
| Last Updated: | April 27, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Disease Coronary Artery Disease Heart Diseases Infarction Myocardial Infarction Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on June 17, 2013