We propose to determine whether major modification of the known risk factors for atherogenesis alters the rate of progression of coronary arterial disease. In order to avoid the problems of clinical end points and large patient groups plaguing other clinical trials, we directly quantitate coronary arterial lesions using angiography and a computer graphics system which provides direct objective end points and small patient requirement. Patients who have had preoperative coronary arteriography and cornoary bypass surgery, but who have not had bypass of all major vessels will be enrolled. They will be randomly assigned to two groups: one to receive an aggressive multiple risk factor reduction program and the other to follow the usual care of their physicians. Those coronary vessels which had noncritical vascular lesions and were therefore not bypassed, provide the substrate for assessing the effectiveness of risk factor modification. Coronary angiography will be carried out prior to surgery and three years later. Computer quantitation of coronary luminal dimensions will provide a sensitive test of changes in coronary atherosclerosis. Two hundred forty patients will be randomized during the initial two years of the project. Clinical status and risk factors will be monitored at baseline and after one, two and three years in all participants. Those patients randomized to aggressive risk factor management will have close followup by study physicians and a """"""""special intervention team."""""""" The resources of the Stanford Heart Disease Prevention will provide specialists in counseling, education programs and instructional materials for self-directed behavior change in the special intervention group. This study's major unique features are: 1) a randomized trial design, 2) the rate of change of coronary atherosclerosis as an end point rather than clinical variables, 3) highly reproducible computer quantitation of coronary atherosclerosis, 4) investigators experienced in long-term clinical intervention trials, 5) availability of the expertise and facilities for aggressive risk factor management, and 6) the use of a subset of patients for serial arteriography in whom restudy is clinically (and ethically) acceptable.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL028292-03
Application #
3339708
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1983-09-30
Project End
1988-09-29
Budget Start
1985-09-30
Budget End
1986-09-29
Support Year
3
Fiscal Year
1985
Total Cost
Indirect Cost
Name
Stanford University
Department
Type
Schools of Medicine
DUNS #
800771545
City
Stanford
State
CA
Country
United States
Zip Code
94305
Williams, P T; Haskell, W L; Vranizan, K M et al. (1995) The associations of high-density lipoprotein subclasses with insulin and glucose levels, physical activity, resting heart rate, and regional adiposity in men with coronary artery disease: the Stanford Coronary Risk Intervention Project baseline survey. Metabolism 44:106-14
Leung, W H; Alderman, E L; Lee, T C et al. (1995) Quantitative arteriography of apparently normal coronary segments with nearby or distant disease suggests presence of occult, nonvisualized atherosclerosis. J Am Coll Cardiol 25:311-7
Haskell, W L; Alderman, E L; Fair, J M et al. (1994) Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). Circulation 89:975-90
Quinn, T G; Alderman, E L; McMillan, A et al. (1994) Development of new coronary atherosclerotic lesions during a 4-year multifactor risk reduction program: the Stanford Coronary Risk Intervention Project (SCRIP). J Am Coll Cardiol 24:900-8
Superko, H R; Haskell, W L; Krauss, R M (1993) Association of lipoprotein subclass distribution with use of selective and non-selective beta-blocker medications in patients with coronary heart disease. Atherosclerosis 101:1-8
Haskell, W L; Sims, C; Myll, J et al. (1993) Coronary artery size and dilating capacity in ultradistance runners. Circulation 87:1076-82
Burge, C; Sanders, W; Alderman, E L (1991) Anatomic and machine projection angles of various radiographic imaging systems used for cardiac angiography. Cathet Cardiovasc Diagn 22:64-74
Leung, W H; Sanders, W; Alderman, E L (1991) Coronary artery quantitation and data management system for paired cineangiograms. Cathet Cardiovasc Diagn 24:121-34
Maron, D J; Fair, J M; Haskell, W L (1991) Saturated fat intake and insulin resistance in men with coronary artery disease. The Stanford Coronary Risk Intervention Project Investigators and Staff. Circulation 84:2020-7
Gao, S Z; Alderman, E L; Schroeder, J S et al. (1990) Progressive coronary luminal narrowing after cardiac transplantation. Circulation 82:IV269-75

Showing the most recent 10 out of 12 publications