Cardiovascular DiseasesNCT00005398
University of North Carolina Alumni Heart Study
An observational study of Cardiovascular Diseases and Heart Diseases, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- 6,340 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: participants in the University of North Carolina Alumni Heart Study
No eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University, Behavioral Medicine Research Center
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Depression
- Being tested
- There is no intervention
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
No applicable
| Study group | Role | What they receive |
|---|---|---|
| 1; no experimental groups in this study | Observational cohort study Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Heart Disease
This is a descriptive cohort study
Measured: approximately 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startMay 1996
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ilene C. Siegler, PhD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005398
- Sponsor's protocol ID
- Pro00013233
- Other IDs
- R01HL055356, P01HL036587, R01MH066079, 4311
- Status last verified
- Jul 2026
- First submitted
- 25 May 2000
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brummett BH, Barefoot JC, Feaganes JR, Yen S, Bosworth HB, Williams RB, Siegler IC. Hostility in marital dyads: associations with depressive symptoms. J Behav Med. 2000 Feb;23(1):95-105. doi: 10.1023/a:1005424405056.
PubMed 10749013Barefoot JC, Heitmann BL, Helms MJ, Williams RB, Surwit RS, Siegler IC. Symptoms of depression and changes in body weight from adolescence to mid-life. Int J Obes Relat Metab Disord. 1998 Jul;22(7):688-94. doi: 10.1038/sj.ijo.0800647.
PubMed 9705031Bastian LA, Couchman GM, Rimer BK, McBride CM, Feaganes JR, Siegler IC. Perceptions of menopausal stage and patterns of hormone replacement therapy use. J Womens Health. 1997 Aug;6(4):467-75. doi: 10.1089/jwh.1997.6.467.
PubMed 9279835Luecken LJ, Suarez EC, Kuhn CM, Barefoot JC, Blumenthal JA, Siegler IC, Williams RB. Stress in employed women: impact of marital status and children at home on neurohormone output and home strain. Psychosom Med. 1997 Jul-Aug;59(4):352-9. doi: 10.1097/00006842-199707000-00003.
PubMed 9251153Herbst JH, McCrae RR, Costa PT Jr, Feaganes JR, Siegler IC. Self-perceptions of stability and change in personality at midlife: the UNC Alumni Heart Study. Assessment. 2000 Dec;7(4):379-88. doi: 10.1177/107319110000700406.
PubMed 11151963Costa PT Jr, Herbst JH, McCrae RR, Siegler IC. Personality at midlife: stability, intrinsic maturation, and response to life events. Assessment. 2000 Dec;7(4):365-78. doi: 10.1177/107319110000700405.
PubMed 11151962Siegler IC, Brummett BH. Associations among NEO personality assessments and well-being at midlife: facet-level analyses. Psychol Aging. 2000 Dec;15(4):710-4. doi: 10.1037//0882-7974.15.4.710.
PubMed 11144330Brummett BH, Maynard KE, Haney TL, Siegler IC, Barefoot JC. Reliability of interview-assessed hostility ratings across mode of assessment and time. J Pers Assess. 2000 Oct;75(2):225-36. doi: 10.1207/S15327752JPA7502_4.
PubMed 11020141McPherson RS, Feaganes JR, Siegler IC. Measurement of dietary intake in the UNC Alumni Heart Study. University of North Carolina. Prev Med. 2000 Jul;31(1):56-67. doi: 10.1006/pmed.2000.0679.
PubMed 10896844Barefoot JC, Gronbaek M, Feaganes JR, McPherson RS, Williams RB, Siegler IC. Alcoholic beverage preference, diet, and health habits in the UNC Alumni Heart Study. Am J Clin Nutr. 2002 Aug;76(2):466-72. doi: 10.1093/ajcn/76.2.466.
PubMed 12145024Siegler IC, Bastian LA, Steffens DC, Bosworth HB, Costa PT. Behavioral medicine and aging. J Consult Clin Psychol. 2002 Jun;70(3):843-51. doi: 10.1037//0022-006x.70.3.843.
PubMed 12090387Bosworth HB, Siegler IC. Terminal change in cognitive function: an updated review of longitudinal studies. Exp Aging Res. 2002 Jul-Sep;28(3):299-315. doi: 10.1080/03610730290080344.
PubMed 12079580Vitaliano PP, Scanlan JM, Zhang J, Savage MV, Hirsch IB, Siegler IC. A path model of chronic stress, the metabolic syndrome, and coronary heart disease. Psychosom Med. 2002 May-Jun;64(3):418-35. doi: 10.1097/00006842-200205000-00006.
PubMed 12021416Surwit RS, Williams RB, Siegler IC, Lane JD, Helms M, Applegate KL, Zucker N, Feinglos MN, McCaskill CM, Barefoot JC. Hostility, race, and glucose metabolism in nondiabetic individuals. Diabetes Care. 2002 May;25(5):835-9. doi: 10.2337/diacare.25.5.835.
PubMed 11978677Brummett BH, Barefoot JC, Vitaliano PP, Siegler IC. Associations among social support, income, and symptoms of depression in an educated sample: the UNC Alumni Heart Study. Int J Behav Med. 2003;10(3):239-50. doi: 10.1207/s15327558ijbm1003_04.
PubMed 14525719
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of North Carolina Alumni Heart Study
- ClinicalTrials.gov ID
- NCT00005398
- Acronym / sponsor ID
- Pro00013233
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,340 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH)
- Study start
- May 1996
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1; no experimental groups in this study | – | Other: There is no interventionObservational cohort study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participants in the University of North Carolina Alumni Heart Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionNo applicable | Other | 1; no experimental groups in this study |
Primary outcome
Coronary Heart Disease
Time frame: approximately 30 years
This is a descriptive cohort study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 10749013Brummett BH, Barefoot JC, Feaganes JR, Yen S, Bosworth HB, Williams RB, Siegler IC. Hostility in marital dyads: associations with depressive symptoms. J Behav Med. 2000 Feb;23(1):95-105. doi: 10.1023/a:1005424405056.
- Background: PubMed 9705031Barefoot JC, Heitmann BL, Helms MJ, Williams RB, Surwit RS, Siegler IC. Symptoms of depression and changes in body weight from adolescence to mid-life. Int J Obes Relat Metab Disord. 1998 Jul;22(7):688-94. doi: 10.1038/sj.ijo.0800647.
- Background: PubMed 9279835Bastian LA, Couchman GM, Rimer BK, McBride CM, Feaganes JR, Siegler IC. Perceptions of menopausal stage and patterns of hormone replacement therapy use. J Womens Health. 1997 Aug;6(4):467-75. doi: 10.1089/jwh.1997.6.467.
- Background: PubMed 9251153Luecken LJ, Suarez EC, Kuhn CM, Barefoot JC, Blumenthal JA, Siegler IC, Williams RB. Stress in employed women: impact of marital status and children at home on neurohormone output and home strain. Psychosom Med. 1997 Jul-Aug;59(4):352-9. doi: 10.1097/00006842-199707000-00003.
- Background: PubMed 11151963Herbst JH, McCrae RR, Costa PT Jr, Feaganes JR, Siegler IC. Self-perceptions of stability and change in personality at midlife: the UNC Alumni Heart Study. Assessment. 2000 Dec;7(4):379-88. doi: 10.1177/107319110000700406.
- Background: PubMed 11151962Costa PT Jr, Herbst JH, McCrae RR, Siegler IC. Personality at midlife: stability, intrinsic maturation, and response to life events. Assessment. 2000 Dec;7(4):365-78. doi: 10.1177/107319110000700405.
- Background: PubMed 11144330Siegler IC, Brummett BH. Associations among NEO personality assessments and well-being at midlife: facet-level analyses. Psychol Aging. 2000 Dec;15(4):710-4. doi: 10.1037//0882-7974.15.4.710.
- Background: PubMed 11020141Brummett BH, Maynard KE, Haney TL, Siegler IC, Barefoot JC. Reliability of interview-assessed hostility ratings across mode of assessment and time. J Pers Assess. 2000 Oct;75(2):225-36. doi: 10.1207/S15327752JPA7502_4.
- Background: PubMed 10896844McPherson RS, Feaganes JR, Siegler IC. Measurement of dietary intake in the UNC Alumni Heart Study. University of North Carolina. Prev Med. 2000 Jul;31(1):56-67. doi: 10.1006/pmed.2000.0679.
- Background: PubMed 12145024Barefoot JC, Gronbaek M, Feaganes JR, McPherson RS, Williams RB, Siegler IC. Alcoholic beverage preference, diet, and health habits in the UNC Alumni Heart Study. Am J Clin Nutr. 2002 Aug;76(2):466-72. doi: 10.1093/ajcn/76.2.466.
- Background: PubMed 12090387Siegler IC, Bastian LA, Steffens DC, Bosworth HB, Costa PT. Behavioral medicine and aging. J Consult Clin Psychol. 2002 Jun;70(3):843-51. doi: 10.1037//0022-006x.70.3.843.
- Background: PubMed 12079580Bosworth HB, Siegler IC. Terminal change in cognitive function: an updated review of longitudinal studies. Exp Aging Res. 2002 Jul-Sep;28(3):299-315. doi: 10.1080/03610730290080344.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilene C. Siegler, PhD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Heart Disease (time frame: approximately 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005398, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.