Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000508
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
1999-10-27
Brief Title:
Stanford Coronary Risk Intervention Project SCRIP
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1993-03
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 whether modification of risk factors altered the rate of progression of coronary artery disease in arteries with mild atherosclerosis and no mechanical intervention in patients who had coronary bypass surgery or percutaneous transluminal coronary angioplasty PTCA
Detailed Description:
BACKGROUND
Because of difficulties with quantitative measurement and with feasibility of follow-up few controlled studies prior to SCRIP had been completed to determine the impact of risk factor modification directly on the progression of coronary atherosclerosis in humans Suggestive evidence existed from animal studies especially in primates that diet and exercise altered atherosclerosis as a result of risk modification But these animal models did not accurately represent the potential for modifying the coronary atherosclerotic process in humans Some indirect evidence had been developed in humans by studying arteries more accessible than the coronaries In the several preliminary studies reported using coronary arteriography to study the impact of risk modification on atherosclerosis the results had been encouraging but far from definitive One angiographic follow-up study of vein bypass grafts and severely atherosclerotic coronary arteries reported improvement with lipid lowering therapy None of these studies had included randomization of patients to systematic intense long-term risk reduction versus usual care with prospectively identified coronary artery segments with mild disease
DESIGN NARRATIVE
Randomized fixed-sample A total of 300 patients were randomized 155 to usual care UC in the community and 145 to special intervention SI The SI group received intensive efforts directed at reducing or eliminating risk factors including lowering LDL-cholesterol and increasing HDL-cholesterol reducing blood pressure eliminating cigarette smoking and obesity increasing exercise and decreasing stressful life experience The major endpoint was the rate of coronary artery disease progression as measured by angiography at baseline and at forty-eight months Follow-up was for four years
Because of difficulties with quantitative measurement and with feasibility of follow-up few controlled studies prior to SCRIP had been completed to determine the impact of risk factor modification directly on the progression of coronary atherosclerosis in humans Suggestive evidence existed from animal studies especially in primates that diet and exercise altered atherosclerosis as a result of risk modification But these animal models did not accurately represent the potential for modifying the coronary atherosclerotic process in humans Some indirect evidence had been developed in humans by studying arteries more accessible than the coronaries In the several preliminary studies reported using coronary arteriography to study the impact of risk modification on atherosclerosis the results had been encouraging but far from definitive One angiographic follow-up study of vein bypass grafts and severely atherosclerotic coronary arteries reported improvement with lipid lowering therapy None of these studies had included randomization of patients to systematic intense long-term risk reduction versus usual care with prospectively identified coronary artery segments with mild disease
DESIGN NARRATIVE
Randomized fixed-sample A total of 300 patients were randomized 155 to usual care UC in the community and 145 to special intervention SI The SI group received intensive efforts directed at reducing or eliminating risk factors including lowering LDL-cholesterol and increasing HDL-cholesterol reducing blood pressure eliminating cigarette smoking and obesity increasing exercise and decreasing stressful life experience The major endpoint was the rate of coronary artery disease progression as measured by angiography at baseline and at forty-eight months Follow-up was for four years
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 |
|---|---|---|---|
| R01HL028292 | NIH | None | httpsreporternihgovquickSearchR01HL028292 |