Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack (TOSCA-2)
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PCI with stenting
Optimal Medical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria: Has experienced a heart attack 3 to 28 days prior to study entry Has a persistently occluded IRA
Sites / Locations
- University Health Network - Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy
Optimal medical therapy alone without PCI of the occluded culprit artery
Outcomes
Primary Outcome Measures
LV ejection fraction
Infarct-related artery patency (measured by contrast LV and coronary angiography)
Secondary Outcome Measures
Comparison of regional wall motion and LV volumes
Effect of reocclusion and spontaneous recanalization on LV function
Effect of duration of occlusion on changes in LV function after PCI
Full Information
NCT ID
NCT00025766
First Posted
October 22, 2001
Last Updated
November 25, 2013
Sponsor
University Health Network, Toronto
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00025766
Brief Title
Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack
Acronym
TOSCA-2
Official Title
TOSCA-2: An Angiographic Substudy (Ancillary) of the Occluded Artery Trial (OAT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Optimal medical therapy alone without PCI of the occluded culprit artery
Intervention Type
Device
Intervention Name(s)
PCI with stenting
Intervention Description
PCI with stenting of the occluded culprit infarct-related artery
Intervention Type
Behavioral
Intervention Name(s)
Optimal Medical Therapy
Intervention Description
Participants will receive optimal medical therapy.
Primary Outcome Measure Information:
Title
LV ejection fraction
Time Frame
1 year
Title
Infarct-related artery patency (measured by contrast LV and coronary angiography)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comparison of regional wall motion and LV volumes
Time Frame
1 year
Title
Effect of reocclusion and spontaneous recanalization on LV function
Time Frame
1 year
Title
Effect of duration of occlusion on changes in LV function after PCI
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has experienced a heart attack 3 to 28 days prior to study entry
Has a persistently occluded IRA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Dzavik, MD
Organizational Affiliation
University Health Network - Toronto General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17105848
Citation
Dzavik V, Buller CE, Lamas GA, Rankin JM, Mancini GB, Cantor WJ, Carere RJ, Ross JR, Atchison D, Forman S, Thomas B, Buszman P, Vozzi C, Glanz A, Cohen EA, Meciar P, Devlin G, Mascette A, Sopko G, Knatterud GL, Hochman JS; TOSCA-2 Investigators. Randomized trial of percutaneous coronary intervention for subacute infarct-related coronary artery occlusion to achieve long-term patency and improve ventricular function: the Total Occlusion Study of Canada (TOSCA)-2 trial. Circulation. 2006 Dec 5;114(23):2449-57. doi: 10.1161/CIRCULATIONAHA.106.669432. Epub 2006 Nov 14.
Results Reference
result
PubMed Identifier
21062997
Citation
Steigen TK, Buller CE, Mancini GB, Jorapur V, Cantor WJ, Rankin JM, Thomas B, Webb JG, Kronsberg SS, Atchison DJ, Lamas GA, Hochman JS, Dzavik V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2. Circ Cardiovasc Interv. 2010 Dec;3(6):549-55. doi: 10.1161/CIRCINTERVENTIONS.109.918722. Epub 2010 Nov 9.
Results Reference
result
PubMed Identifier
19309733
Citation
Dzavik V, Buller CE, Devlin G, Carere RG, Mancini GB, Cantor WJ, Buszman PE, Rankin JM, Vozzi C, Ross JR, Forman S, Barton BA, Lamas AG, Hochman JS. Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial. Catheter Cardiovasc Interv. 2009 May 1;73(6):771-9. doi: 10.1002/ccd.21930.
Results Reference
result
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Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack
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