Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025766
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2001-10-22
Brief Title:
Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
TOSCA-2 An Angiographic Substudy Ancillary of the Occluded Artery Trial OAT
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOSCA-2
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL067683 | NIH | None | httpsreporternihgovquickSearchR01HL067683 |