Trial Information

BACKGROUND:

MRFIT was initiated in 1972 as a randomized, multicenter primary prevention trial designed
to determine whether a special intervention consisting of smoking cessation, cholesterol
reduction and control of high blood pressure, would result in a significant reduction in
coronary heart disease (CHD) mortality, compared to usual care. Follow-up and analysis has
continued on the 361,662 men screened and the 12,866 men randomized.

DESIGN NARRATIVE:

The National Death Index (NDI) will be used for continued follow-up of the MRFIT cohorts.
An additional assay to establish IGF-1 and IGF binding protein will be added to the data set
as a potential prognostic factor. The effort will focus on three primary aims related to
long-term mortality. Aim 1 will relate nutritional-dietary data to twenty-five year
mortality from coronary heart disease (CHD), stroke, cardiovascular disease (CVD), colon
cancer, prostate cancer, and all causes for the 12,866 men randomized. Aim 2 will relate
age, ethnicity, socioeconomic position, geographic location, major risk factors, low risk
status, prior diabetes, and prior myocardial infarction to twenty-five year mortality for
the 361,662 men screened. Aim 3 will relate insulin-like growth factor 1 (IGF-1), IGF
binding protein, and fasting and one-hour glucose measurements from frozen baseline sera to
mortality for the 12,866 men randomized.