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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005498 |
To test the hypothesis that high levels of hostility, depressive symptoms, and stressful life events would be associated with all cause and cardiovascular disease (CVD) mortality after 16 years of follow-up in the Multiple Risk Factor Intervention Trial (MRFIT).
Condition |
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Cardiovascular Diseases Coronary Disease Heart Diseases Depression |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | October 2001 |
BACKGROUND:
MRFIT was 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. The study presented a unique opportunity to test in a cost-efficient manner the association of psychosocial factors and mortality in a large, well characterized sample of middle-aged men.
DESIGN NARRATIVE:
The sample was composed of 12,866 men who at the time of study entry were in the top 15 percent of a risk score distribution based on the Framingham Heart Study data, but had no clinical evidence of CHD. During the trial, annual measurements were taken, which included some health behaviors, stressful life events, feelings of anger and hostility. A subset of 3,110 men also were administered once the Type A Structured Interview from which Potential for Hostility could be rated and all men who survived until the sixth year of the trial were administered the CES-Depression scale.
After approximately seven years of the active phase of the trial, the men were followed for an additional 9 years for mortality and cause of death. To test the major study hypotheses, the investigators coded all Type A Structured Interview tapes for Potential for Hostility, and components of hostility (Style, Intensity, Content) and constructed and validated a self-report measure of hostility from items administered to all participants. Cox proportional hazard regression techniques were used to test the association of hostility, depression, and stressful life events with all cause and CVD mortality. If the major study hypotheses were confirmed, then educational attainment, baseline risk factors, change in risk factors, and adherence indicators would be included in subsequent analyses.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5016 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005498 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Depression Heart Diseases Myocardial Ischemia Vascular Diseases |
Stress Arteriosclerosis Ischemia Depressive Disorder Coronary Artery Disease Behavioral Symptoms |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Depression Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease Behavioral Symptoms |