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Stanford Coronary Risk Intervention Project (SCRIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000508
First Posted: October 28, 1999
Last Update Posted: January 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Stanford University
  Purpose
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).

Condition Intervention Phase
Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Behavioral: smoking cessation Behavioral: diet, reducing Behavioral: exercise Behavioral: diet, fat-restricted Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Further study details as provided by Stanford University:

Study Start Date: September 1983
Estimated Study Completion Date: March 1993
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, up to 75 years of age. Patients with coronary artery disease but no mechanical intervention on all major vessels.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000508


Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Edwin Alderman Stanford University
OverallOfficial: Ronald Krauss University of California
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00000508     History of Changes
Other Study ID Numbers: 27
R01HL028292 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: January 12, 2016
Last Verified: March 1993

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases