Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack (TOSCA-2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00025766
First received: October 22, 2001
Last updated: November 25, 2013
Last verified: November 2013
  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)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
Criteria

Inclusion Criteria:

  • Has experienced a heart attack 3 to 28 days prior to study entry
  • Has a persistently occluded IRA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025766

Locations
Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Study Chair: Vladimir Dzavik, MD University Health Network - Toronto General Hospital
  More Information

Publications:
Responsible Party: Dr. Vladimir Dzavik, University Health Network, Toronto, ON, Canada
ClinicalTrials.gov Identifier: NCT00025766     History of Changes
Other Study ID Numbers: 989, R01HL067683, R01 HL67683
Study First Received: October 22, 2001
Last Updated: November 25, 2013
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 July 22, 2014