The Stanford Coronary Risk Intervention Project (SCRIP) is a randomized trial to determine if aggressive multiple risk factor reduction by patients with coronary atherosclerosis can significantly alter the rate of progression or produce regression of their atherosclerosis as determined by computer-assisted coronary arteriographic quantitation. Following baseline arteriography, 300 patients were randomized to either the usual care (UC) of their own physician or to a special intervention (SI) group. All patients completed a comprehensive baseline clinical/risk factor evaluation and are completing a similar evaluation annually for four years including a four year repeat arteriogram. SI patients receive an aggressive program of risk reduction from SCRIP staff including a low fat and cholesterol diet, exercise promotion, smoking cessation, weight loss when indicated, and lipid lowering medication if needed. The scientific and logistical integrity of the project has been excellent. All patients have completed at least three years in the study and 170 have completed four years, including their follow-up arteriogram. The participation rate at each annual evaluation has exceeded 93% and it is projected that 270 patients (90%) will complete the trial with follow-up arteriograms (by February 1991). Minimal risk factor change has occurred in the UC group, while significant changes have been made by the SI group in plasma lipoprotein concentrations, dietary intake of fat and cholesterol, body weight, exercise capacity and risk score. The computer-based angiographic measurement system has been upgraded and provides accurate and reproducible measurements of changes in coronary artery diameter. The major objectives of this continuation proposal are twofold. First, to support data analysis and preparation of reports using data collected during the randomized trial. This request is due, in part, to a 6-month reduction in the duration of the funded grant period due to truncation of grant year-5 from 12 to 6 months. SCRIP analysis will focus on the primary aims of the project as well as a variety of additional aims that take advantage of the large amount of high quality and unique data collected during the project. The second objective is to support clinical and risk factor follow-up of all patients at one year and three years after completion of the 4-year randomized trial. This follow-up is to determine if the lower rate of myocardial infarction and CABG surgery recently observed for the SI patients vs. UC patients continues, and to document the effects of the 4-year intervention on other medical events and major cardiac risk factors during the next three years. These data will increase our understanding of the longer term clinical benefits and potential side effects of aggressive multifactor risk reduction.
Showing the most recent 10 out of 12 publications
