Mortality Follow-Up and Analyses of Men in the MRFIT
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Purpose
To extend mortality followup through 25 years for two cohorts of men in the Multiple Risk Factor intervention Trial (MRFIT): the 361,662 men screened and the 12,866 men randomized, and to pursue the general aim of elucidating unresolved research issues on the epidemiology, natural history, etiology, prevention, and control of major chronic diseases, particularly cardiovascular and neoplastic diseases and diabetes.
| Condition |
|---|
|
Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Ischemia Diabetes Mellitus Cerebrovascular Accident Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Study Start Date: | January 2001 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
No eligibility criteria
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00011206 History of Changes |
| Other Study ID Numbers: | 963 |
| Study First Received: | February 13, 2001 |
| Last Updated: | January 18, 2008 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Myocardial Ischemia Coronary Artery Disease Coronary Disease Diabetes Mellitus Heart Diseases Infarction Ischemia Myocardial Infarction Cerebral Infarction Stroke Vascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Necrosis Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013