Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005498
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005498
Brief Title
Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
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).
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Matthews
Organizational Affiliation
University of Pittsburgh
12. IPD Sharing Statement
Citations:
PubMed Identifier
11020089
Citation
Gump BB, Matthews KA. Are vacations good for your health? The 9-year mortality experience after the multiple risk factor intervention trial. Psychosom Med. 2000 Sep-Oct;62(5):608-12. doi: 10.1097/00006842-200009000-00003.
Results Reference
background
PubMed Identifier
14662707
Citation
Matthews KA, Gump BB, Harris KF, Haney TL, Barefoot JC. Hostile behaviors predict cardiovascular mortality among men enrolled in the Multiple Risk Factor Intervention Trial. Circulation. 2004 Jan 6;109(1):66-70. doi: 10.1161/01.CIR.0000105766.33142.13. Epub 2003 Dec 8.
Results Reference
background
PubMed Identifier
12867355
Citation
Gump BB, Matthews KA. Special intervention reduces CVD mortality for adherent participants in the multiple risk factor intervention trial. Ann Behav Med. 2003 Aug;26(1):61-8. doi: 10.1207/S15324796ABM2601_08.
Results Reference
background
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Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?
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