Mortality Follow-Up and Analyses of Men in the MRFIT

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011206
• Other study ID #: 963
• Secondary ID: R01HL068140
• Status: Completed
• Phase: N/A
• First received: February 13, 2001
• Last updated: March 14, 2014
• Start date: January 2001
• Est. completion date: June 2006

Study information

• Verified date: March 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older
• Eligibility: No eligibility criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Diseases
• Myocardial Infarction
• Myocardial Ischemia
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (9)

Davey Smith G, Bracha Y, Svendsen KH, Neaton JD, Haffner SM, Kuller LH; Multiple Risk Factor Intervention Trial Research Group. Incidence of type 2 diabetes in the randomized multiple risk factor intervention trial. Ann Intern Med. 2005 Mar 1;142(5):313-22. — View Citation

Domanski M, Mitchell G, Pfeffer M, Neaton JD, Norman J, Svendsen K, Grimm R, Cohen J, Stamler J; MRFIT Research Group. Pulse pressure and cardiovascular disease-related mortality: follow-up study of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA. 2002 May 22-29;287(20):2677-83. — View Citation

Eberly LE, Cohen JD, Prineas R, Yang L; Intervention Trial Research group. Impact of incident diabetes and incident nonfatal cardiovascular disease on 18-year mortality: the multiple risk factor intervention trial experience. Diabetes Care. 2003 Mar;26(3):848-54. — View Citation

Eberly LE, Ockene J, Sherwin R, Yang L, Kuller L; Multiple Risk Factor Intervention Trial Research Group. Pulmonary function as a predictor of lung cancer mortality in continuing cigarette smokers and in quitters. Int J Epidemiol. 2003 Aug;32(4):592-9. — View Citation

Eberly LE, Stamler J, Neaton JD; Multiple Risk Factor Intervention Trial Research Group. Relation of triglyceride levels, fasting and nonfasting, to fatal and nonfatal coronary heart disease. Arch Intern Med. 2003 May 12;163(9):1077-83. — View Citation

Gump BB, Matthews KA, Eberly LE, Chang YF; MRFIT Research Group. Depressive symptoms and mortality in men: results from the Multiple Risk Factor Intervention Trial. Stroke. 2005 Jan;36(1):98-102. Epub 2004 Nov 29. — View Citation

Prineas RJ, Grandits G, Rautaharju PM, Cohen JD, Zhang ZM, Crow RS; MRFIT Research Group. Long-term prognostic significance of isolated minor electrocardiographic T-wave abnormalities in middle-aged men free of clinical cardiovascular disease (The Multiple Risk Factor Intervention Trial [MRFIT]). Am J Cardiol. 2002 Dec 15;90(12):1391-5. — View Citation

Thomas AJ, Eberly LE, Neaton JD, Smith GD; Multiple Risk Factor Intervention Trial Research Group. Latino risk-adjusted mortality in the men screened for the Multiple Risk Factor Intervention Trial. Am J Epidemiol. 2005 Sep 15;162(6):569-78. Epub 2005 Aug 2. — View Citation

Vaccaro O, Eberly LE, Neaton JD, Yang L, Riccardi G, Stamler J; Multiple Risk Factor Intervention Trial Research Group. Impact of diabetes and previous myocardial infarction on long-term survival: 25-year mortality follow-up of primary screenees of the Multiple Risk Factor Intervention Trial. Arch Intern Med. 2004 Jul 12;164(13):1438-43. — View Citation