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Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack
This study is ongoing, but not recruiting participants.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00025766
  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
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Procedure: PTCA and Stenting

MedlinePlus related topics: Angioplasty Coronary Artery Disease Heart Attack Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Parallel Assignment, Efficacy Study
Official Title: TOSCA-2: An Angiographic Substudy (Ancillary) of the Occluded Artery Trial (OAT)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • LV ejection fraction
  • Infarct-related artery patency (measured by contrast LV and coronary angiography at Year 1)

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 (measured at Year 1)

Estimated Enrollment: 380
Study Start Date: September 2001
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
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
Investigators
Study Chair: Vladimir Dzavik, MD University Health Network - Toronto General Hospital
  More Information

Study ID Numbers: 989, R01 HL67683
Study First Received: October 22, 2001
Last Updated: November 6, 2006
ClinicalTrials.gov Identifier: NCT00025766  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009