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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | August 1978 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005144 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Coronary-Prone Behavior and Cardiovascular Reactivity |
| Official Title ICMJE | |
| Brief Summary | To further clarify the concept of coronary-prone behavior and to develop methods of assessing coronary-prone behavior. Specifically, to revise the component scoring system for Potential for Hostility in the Structured Interviews measure of Type A behavior. |
| Detailed Description | BACKGROUND: In 1978, a select Review Panel of biomedical and behavioral scientists met under the auspices of the NIH to evaluate the data linking the Type A behavior pattern to coronary heart disease. Based on the scientific evidence available to them in December, 1978, the members of the Panel issued a report in which they concluded that the Type A behavior pattern was an independent risk factor for coronary heart disease, of a magnitude similar to that of other established risk factors, such as cigarette smoking and serum cholesterol. At the time the Panel met, the most impressive evidence linking the Type A behavior pattern to coronary heart disease was the prospective Western Collaborative Group Study (WCGS), which established a significant risk ratio for Structured Interview-assessed Type A behavior pattern for all clinical manifestations of coronary heart disease; and three angiographic studies which reported significant associations between Structured Interview-defined Type A behavior pattern and severity of coronary artery disease. Supporting evidence was provided by prevalence studies employing the Jenkins Activity Survey (JAS) measure of Type A behavior pattern, and by incidence and prevalence data from the Framingham study, using a six-item scale thought to assess aspects of Type A behavior. Subsequent to the conference, studies had begun to emerge which called into question the robustness of the association between the Type A behavior pattern and various manifestations of coronary heart disease. The most damaging of these was the prospective Type A study included in MRFIT. In this study, 3,110 men were given the Structured Interview and Jenkins Activity Survey, and followed for an average period of seven years, while receiving annual medical examinations. Analysis of the results at the end of the seven years revealed that Type A behavior pattern, however assessed, was completely unrelated to either coronary death or documented myocardial infarction. A major tool was the component scoring system for the Structured Interview to determine which of the many attributes comprising the multidimensional Type A behavior pattern were actually associated with coronary heart disease. Component scoring had demonstrated that some components had consistent associations with coronary heart disease, even when the global Type A behavior pattern showed no relationship. Component analysis of the Type A behavior pattern in MRFIT revealed that of all the attributes assessed, only Potential for Hostility was significantly related to incidence of coronary heart disease. Several other studies were conducted under this project. Tape-recorded Structured Interviews from the Western Collaborative Group Study were reanalyzed to assess the relationship between components of Type A behavior and incidence of coronary heart disease. Rescoring was completed on Structured Interviews of over 1,000 subjects who had undergone stress testing while blood pressure and heart rate were recorded. An analysis was also conducted on the influence of cigarette smoking and situational stress on cardiovascular response in young male subjects. DESIGN NARRATIVE: In Study I, tape-recorded Structured Interviews from MRFIT were re-scored for Potential for Hostility. In Study II, Structured Interviews were obtained from a new sample of participants in the BLSA. In the BLSA the Structured Interview were expanded to include questions that dealt more directly and sampled more fully antagonistic self-descriptions, attitudes, and behaviors. Alternative measures of Agreeableness-Antagonism were already available from the BLSA sample that were used to validate scores from the expanded Structured Interview, and biomedical information on BLSA participants was used to further test the predictive utility of Antagonistic Hostility as a risk factor for coronary heart disease. Previous research had scored Potential for Hostility from the Structured Interview by examining Content, Intensity, and Style as well as a clinical judgement of Total Potential for Hostility. In the present study, Antagonistic Hostility was measured in terms of Antagonistic Style and Self-Descriptions. A total score was defined as the sum of these two components. Antagonistic Style was scored using a 5-point scale when rudeness, condescension, and disagreeableness were expressed toward the interviewer. Matched and unmatched logistic regressions were used to evaluate Antagonistic Hostility as a risk factor for morbidity and mortality outcomes. Multivariate analyses were used to control for other standard risk factors. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | December 1990 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005144 |
| Responsible Party | |
| Study ID Numbers ICMJE | 1015 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | April 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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