Mortality Follow-Up and Analyses of Men in the MRFIT

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00011206
First received: February 13, 2001
Last updated: March 14, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Study Start Date: January 2001
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011206

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: James Neaton University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00011206     History of Changes
Other Study ID Numbers: 963, R01HL068140
Study First Received: February 13, 2001
Last Updated: March 14, 2014
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 April 17, 2014