Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005498
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

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
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Depression

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1998
Estimated Study Completion Date: October 2001
Detailed Description:

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.

  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: NCT00005498

Sponsors and Collaborators
Investigators
Investigator: Karen Matthews University of Pittsburgh
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005498     History of Changes
Other Study ID Numbers: 5016
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Depression
Depressive Disorder
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014