Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005498
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12866 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 3110 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
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 12866 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 3110 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL058867 | NIH | None | httpsreporternihgovquickSearchR01HL058867 |