Cardiovascular Diseases Clinical Trial
Official title:
TOSCA-2: An Angiographic Substudy (Ancillary) of the Occluded Artery Trial (OAT)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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