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Stanford Coronary Risk Intervention Project (SCRIP)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000508
Enrollment
Unknown
Registered
1999-10-28
Start date
1983-09-30
Completion date
1993-03-31
Last updated
2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Myocardial Ischemia

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.

Interventions

BEHAVIORALsmoking cessation
BEHAVIORALdiet, reducing
BEHAVIORALexercise

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Men and women, up to 75 years of age. Patients with coronary artery disease but no mechanical intervention on all major vessels.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026