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

Cardiovascular Diseases Clinical Trial

— TOSCA-2  

Official title:

TOSCA-2: An Angiographic Substudy (Ancillary) of the Occluded Artery Trial (OAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025766
• Other study ID #: 989
• Secondary ID: R01HL067683
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2001
• Last updated: November 25, 2013
• Start date: September 2001
• Est. completion date: December 2011

Study information

• Verified date: November 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2011
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Has a persistently occluded IRA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Infarction

Intervention

Device:
• PCI with stenting
PCI with stenting of the occluded culprit infarct-related artery

Behavioral:
• Optimal Medical Therapy
Participants will receive optimal medical therapy.

Locations

Country	Name	City	State
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Dzavík 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 Arte — View Citation

Dzavík 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. Randomize — View 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, Džavík V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional le — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV ejection fraction		1 year	No
Primary	Infarct-related artery patency (measured by contrast LV and coronary angiography)		1 year	No
Secondary	Comparison of regional wall motion and LV volumes		1 year	No
Secondary	Effect of reocclusion and spontaneous recanalization on LV function		1 year	No
Secondary	Effect of duration of occlusion on changes in LV function after PCI		1 year	No