Tobacco Documents Online

y{KL!0631034 HEW NEWS U.S. DEI+ARTAiENT OF HEALTH, E+)UCATION, AND WELFARE - National Institutes of Health Bethesda, Maryland 20014 NATIONAL HEART AND LUNG INSTITUTE BILL SANDERS Office (301) 496-42~6 Home (301) 649-4294 NEWS RELEASE Mailed 1/31/72 for use u pon receipt The National Heart and Lung Institute will soon undertake a large- scale clinical trial to determine to what extent illness and death from coro- nary heart disease can be reduced through measures to modify or eliminate three common risk factors, Dr. Theodore Cooper, NHLI Director, announced today. The NHLI Clinical Applications Program is currently inviting contract proposals for the development and conduct of a.-'ultiple Risk Factor Controlled Clinical Trial to determine whether a prt-rentive program diractej at the red,,<- tion uf elevate.S serim lipids, blczd p-essure, ead cigarette smoking among high-risk males aged 40-59 can achieve a significant reduction in the incidence of heart attacks and death from coronary heart disease over a six-year period of medical management. According to present estimates, approximately 800 of death and disability from cardiovascuiar diseases occurs among persons having one or more of these risk factors working against them. Two or more risk factors are commonly present in the same individual, and persons with all three risk factors are at especially high risk from arteriosclerosi~ and its complications, such as acute heart attacks. For example, data gathered from the NHI.I-sponsored Framingham Heart Disease Study show that men with one risk factor had a clinical incidence of coronary heart disease of 1.9 times the rate of men with none of these risk factors. With two risk factots present, the incidence was 3.4 times higher, and with all three factors the incidence was 10.6 times that found among men with none. (mpre)

NKE0631U3F) I I Contracts in support of the Clinical Trial will be awarded qri the basis of national competition to medical investigators juaged best qualified to establish necessary cooperative arrangements; to undertake the screening, evaluation, and enrollment of participants; and to maintain medicel-management regimens for the six-year follotiv-up period. Adequate clinical facilities must be available at each potential partici- pating center to recruit at least 600 men at high risk because of high blood lipids, elevated blood pressure, or cigarette smoking, and to mahege at least 300 high risk men in the study group. Each study participant mustt be seen at least 4-6 times per year (more initially) and each member of the control group once per year. Contract recipients will use a common protocol with standarklfization of measurements and clinical procedures. These will be developed by the principal investigators of each clinic in conjunction with the NHLI program office staff and with a Steering Committee and Policy Board for this collaborative project. Mer recruited by each center will receive medical and laboratory evalua- tion at the startt o' the program and periodically over a planned six years of follow-up. A special program relating to diet, blood pressure reduction, and reduction or discontinuation of cigarette smoking will be undertaken for one half of the participants while the remainder would be referred back to their personal physicians or usual medical care centers. It is anticipated that the combined intervention involved in this trial would undertake procedures for reduction of these factors which could be ap- plied by a physician in his treatment of a patient, and thet this trial could serve to expedite the development and application of new knowledge essential for improved diagnosis, treatment, and prevention of coronary heart disease. An announcement of this contract program appeared in Commerce Business Daily, 12/17/71. A mailing of invitations to potentially interested in- vestigators has been made.