The multiple risk factor intervention trial (MRFIT): I. Historical perspectives

Abstract

The beginnings of the Multiple Risk Factor Intervention Trial (MRFIT) for the primary prevention of coronary heart disease (CHD) are chronicled. Over the period 1960–1970, various scientific panels had urged the undertaking of primary CHD prevention trials but with limited consensus on the specific type of study needed. The Task Force on Arteriosclerosis convened by the National Heart and Lung Institute (NHLI) in 1971 recommended that a national diet-heart trial not be supported but, instead, that the NHLI undertake multiple risk factor intervention trials in individuals at high risk of CHD due to combinations of elevated serum lipids, hypertension, and cigarette smoking. Late in 1971, the NHLI invited proposals for MRFIT. Its primary purpose was to determine whether a special risk factor intervention program directed at the reduction of elevated serum cholesterol, elevated diastolic blood pressure, and cigarette smoking in men at high risk of death from CHD (but still free of clinical evidence of CHD) would result in a significant reduction in CHD mortality; nonfatal myocardial infarction or CHD mortality; cardiovascular mortality; and mortality from all causes—over a 6-year period. In 1972–1973, funds to conduct such a study among 12,000 randomized men were awarded to 22 clinical centers, a coordinating center, central laboratory, standardization laboratory, ECG centers, and a drug distribution center. The evolution of the organization of this research undertaking is described.