Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000605
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
1999-10-27
Brief Title:
Estrogen and Graft Atherosclerosis Research Trial EAGER
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-04
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:
None
Brief Summary:
To determine if postmenopausal hormone replacement therapy in women following coronary bypass surgery would reduce the occurrence of graft occlusion and delay the development of graft atherosclerosis
Detailed Description:
BACKGROUND
Coronary atherosclerosis is a major cause of death in women in the United States Although coronary artery bypass surgery decreases symptomatic and clinical evidence of ischemia it does not alter the underlying process Patients may present several years later with recurrent symptoms that may be a result of occlusion of saphenous vein grafts development of atherosclerotic disease in vein grafts or progression of underlying disease Any intervention that can reduce the rate of progression of coronary atherosclerosis following bypass surgery would provide significant benefit for women following bypass surgery and possibly for other women with atherosclerotic disease Observational studies suggest that postmenopausal estrogen replacement therapy is associated with a reduction in cardiac morbidity
DESIGN NARRATIVE
The study was a randomized double-blind controlled trial Subjects were randomized to conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass surgery Graft occlusion and development of vein graft atherosclerosis were measured by comparing quantitative coronary angiographic and vascular ultrasonic assessment of disease severity and extent performed at six months and three and a half years after randomization The primary outcome variables included the occurrence of graft occlusion at six months and the change in severity and extent of atherosclerosis in the saphenous vein grafts over three years The trial determined the influence of hormone replacement therapy on the primary outcome variables
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Coronary atherosclerosis is a major cause of death in women in the United States Although coronary artery bypass surgery decreases symptomatic and clinical evidence of ischemia it does not alter the underlying process Patients may present several years later with recurrent symptoms that may be a result of occlusion of saphenous vein grafts development of atherosclerotic disease in vein grafts or progression of underlying disease Any intervention that can reduce the rate of progression of coronary atherosclerosis following bypass surgery would provide significant benefit for women following bypass surgery and possibly for other women with atherosclerotic disease Observational studies suggest that postmenopausal estrogen replacement therapy is associated with a reduction in cardiac morbidity
DESIGN NARRATIVE
The study was a randomized double-blind controlled trial Subjects were randomized to conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass surgery Graft occlusion and development of vein graft atherosclerosis were measured by comparing quantitative coronary angiographic and vascular ultrasonic assessment of disease severity and extent performed at six months and three and a half years after randomization The primary outcome variables included the occurrence of graft occlusion at six months and the change in severity and extent of atherosclerosis in the saphenous vein grafts over three years The trial determined the influence of hormone replacement therapy on the primary outcome variables
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01HL050840 | NIH | None | httpsreporternihgovquickSearch5U01HL050840 |