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Trial NCT00000508

Resource URI: http://static.linkedct.org/resource/trials/NCT00000508
linkedct:brief_title Stanford Coronary Risk Intervention Project (SCRIP)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3361>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women, up to 75 years of age. Patients with coronary artery disease but no mechanical intervention on all major vessels.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 1993
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000508
rdfs:label Trial NCT00000508
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000508
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 27
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15628>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/51847>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000508>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/37398>
linkedct:reference <http://static.linkedct.org/resource/reference/37825>
linkedct:reference <http://static.linkedct.org/resource/reference/38529>
linkedct:reference <http://static.linkedct.org/resource/reference/46778>
linkedct:reference <http://static.linkedct.org/resource/reference/47594>
linkedct:reference <http://static.linkedct.org/resource/reference/50997>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1983
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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).
rdf:type linkedct:trials
linkedct:verification_date March 1993