This proposal is a resubmission that preserves that aspects considered """"""""strengths"""""""" by the majority reviewers and addresses those points raised by the minority. The Birmingham Center of the Multiple Risk Factor Intervention Trial (MRFIT) screened 22,235 men in 1974-75, to identify and recruit 606 informed randomized volunteers; each of whom was in the highest 15 percent (later changed to 10 percent) at risk for developing coronary artery disease, but had no disease manifestations as yet. One half of the randomized cohort (SPECIAL INTERVENTION) had intensive intervention to lower cholesterol (diet; later, weight loss and diet); stop cigarette smoking (group sessions for behavior modification); and control hypertension (salt restriction, weight loss, and then anti-hypertensive stepped care routine, as needed). The other random half (USUAL CARE) has been treated by their regular physicians in the community, whose option it has been to intervene or not intervene in these risk factors. Both SI and UC participants have been examined annually, to record health status and risk factor levels. Results of intensive intervention (SI) have been gratifying. Preset goals for stopping cigarette smoking, and for blood pressure control have been achieved. Cholesterol has dropped significantly also, although not to the present goal levels. These excellent changes are offset in part by a totally unanticipated drop in these risk factors in the referred group (UC). This study proposes to recruit 1124 of those originally screened but not randomized, and to recheck the risk factor levels and medical histories in all; plus, in half of them, to do a more detailed assessment for atherosclerosis-related abnormalities. In addition, deaths and morbid events in the group will be corroborated by death certificates and interviews with physician, workers, and/or family; as appropriate. The secular changes in risk factors from initial screening (1974-1975) will be correlated with the change in calculated risk status in the six year interval. The changes will be documented not only for the highest risk group part of whom have been MRFIT participants; but also for each 1974-1975 stratum or risk; from below 10 percent all the way up to 90 percent plus. Thus, the data becomes a check against MRFIT Usual Care participants' risk factor changes, plus a method of assessing more objectively the role of risk factor change in the recently decreasing cardiovascular morbidity and mortality.
