University of North Carolina Alumni Heart Study
| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | January 25, 2008 | ||||
| Start Date ICMJE | May 1996 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00005398 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | University of North Carolina Alumni Heart Study | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To continue surveillance of the participants in the University of North Carolina Alumni Heart Study, which tests the hypothesis that hostility and related psychosocial factors are involved in the pathogenesis of coronary heart disease. |
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| Detailed Description | BACKGROUND: Prevention of coronary heart disease (CHD) will be enhanced by controlling hypertension, reducing blood cholesterol, maintaining normal weight, increasing physical activity, reducing smoking, and having a healthy diet. Understanding how to achieve these important public health aims requires an understanding of the behavioral factors involved in prevention. Behavioral risk factors remain the single most preventable cause of human illness and suffering. The University of North Carolina Alumni Heart Study is ideally suited to explore the associations between and among these important behavioral risk factors, and to understand how personality, in particular individual differences in hostility and depression act to determine individuals' risk factor behaviors, and to answer important questions about the role of hostility and psychosocial factors in CHD risk during the middle years. The University of North Carolina Alumni Heart Study (UNCAHS) is a prospective study of the role of psychosocial factors, in particular hostility, in the development of coronary heart disease. The target population is composed of persons who completed the Minnesota Multiphasic Personality Inventory while attending the University of North Carolina in the mid-1960s. DESIGN NARRATIVE: Surveillance of the members of the UNC Alumni Heart Study continues for an additional five-year period . Studies continue on how hostility and other psychosocial factors are related to each other and how they contribute to coronary heart disease risk. Data are analyzed in order to test hypotheses about the role of psychosocial factors in weight parameters, dietary practices and the contribution of spouse hostility to coronary risk. To better understand the dynamic interrelationships of psychosocial and behavioral risk factors of the adult life span, the trajectories of hostility, depression, smoking, body mass, exercise patterns, and alcohol consumption will be mapped using multiple assessments from age 19 to age 60. It is predicted that a significant proportion of the change in risk behavior will be due to trajectories of hostility and depression, operating singly and in combination over time. Tests will be made of the prospective associations of hostility, depression, and other psychosocial variables (e.g., social support and job strain) with coronary events and mortality observed while the cohort is middle-aged. The scope of the psychosocial variables will be broadened to examine individual differences in personality over the life course and dietary practices at midlife in addition to the indicators noted above. The effect of gender on the natural history of coronary disease and coronary risk profiles in women will be examined by monitoring changes in menopausal status, and patterns of hormone replacement therapy use among women during midlife and the associations of these factors with the other risk indicators. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00005398 | ||||
| Other Study ID Numbers ICMJE | 4311 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2008 | ||||
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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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