Cardiovascular DiseasesNCT00005314
Behavioral Factors in Coronary Heart Disease
An observational study of Cardiovascular Diseases and Heart Diseases, run by Duke University.
Trial summary
To elucidate the role of biobehavioral factors in the etiology, pathogenesis and course of coronary heart disease (CHD) and to use this knowledge to devise more effective prevention, treatment and rehabilitation approaches. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- 694 participants
- Where
- No sites listed yet
- Study dates
- Jul 1986to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy normal volunteers
We will recruit 500 probands (half African American and half Caucasian, half men and half women, and half scoring in the top and half in the bottom 20% on an established hostility scale), at least one sibling from each proband and as many parents as possible.
About this study
To elucidate the role of biobehavioral factors in the etiology, pathogenesis and course of coronary heart disease (CHD) and to use this knowledge to devise more effective prevention, treatment and rehabilitation approaches.
Read the detailed description
BACKGROUND:
The integrating theme of the study is that hostility affects both behaviors and biologic functions in ways that increase the risks of developing coronary atherosclerosis or suffering an acute CHD event. Disciplines involved include psychology, internal medicine, cardiology, psychiatry, pharmacology, biostatistics, epidemiology, and molecular biology.
DESIGN NARRATIVE:
There were five subprojects in the original program project grant. Subproject 1 examined the social, behavioral and biologic concommitants of both natural and experimental interpersonal conflicts as a function of multimodal hostility assessments. Subproject 2 examined the role of hostility and social support in survival among CHD patients and attempted to identify the behavioral mediators of survival effects. Subproject 4 evaluated the effects of hostility, both alone and jointly with risk factors and social factors, on CHD incidence in over 5,000 participants in the University of North Carolina Alumni Heart Study. Subproject 5 evaluated the effects of age, smoking, lipids, and adrenergic receptors on physiologic reactivity of hostile and nonhostile men to anger induced by interpersonal challenges in the lab as well as the events of daily life. Subproject 7 extended the evaluation of anger-associated biologic reactivity in hostile and nonhostile persons by studying biobehavioral responses of 200 women employed in a real world high stress work situation; it also evaluated the impact of a stress management intervention designed to reduce anger on biobehavioral reactivity in these same employees.
The study was renewed in fiscal year (FY) 1997 to expand the primary focus on hostility to include a set of psychosocial, behavioral, and biological characteristics that increased coronary heart disease risk and appeared to cluster in certain individuals and groups, especially those low in socioeconomic status (SES). Subproject 1 examined in approximately 360 subjects the synergistic effects of SES and psychosocial risk factors such as depression, hostility, and social isolation on biological and behavioral factors suspected or known to contribute to atherogenesis. Subproject 2 evaluated the role of the central nervous system serotonin function as a potential mediator of the clustering of health-damaging psychosocial and biobehavioral characteristics in the same individuals and low SES groups. Subproject 3, the Psychosocial Risk for Cardiovascular Disease in Youth Project (PRCVDYP), used three ongoing general population studies of youth as a basis for examining the development of psychosocial risk for cardiovascular disease. The investigators hypothesized that low SES youth would exhibit, in addition to increased levels of the psychosocial and behavioral risk factors under study, increased sympathetic nervous system tone and reactivity to mental challenge, as well as decreased peripheral nervous system tone. They also hypothesized that depression, social isolation, and harsh parenting will interact with low SES to increase cardiovascular disease risk. Subproject 4 used a rat model to investigate early experience, serotonin and adult function.
The study was renewed in FY 2004 and includes three subprojects. Subproject 1 will determine the role of gene-environment interactions in the expression of psychosocial and biobehavioral risk factors for cardiovascular disease. Variants will be identified in candidate genes and chromosomal loci that are associated with the endophenotypes of hostility, personality, other psychosocial risk factors, health behaviors, and the following responses to rest and stress -- cardiovascular and neuroendocrine function, platelet activation and serotonin transporter function, circulatory inflammatory markers and the tendency of all of these characteristics to cluster in the same individuals and low socioeconomic groups. A total of 400 probands (half African American, half Caucasian, half women) and at least one sibling for each proband will be recruited for a total of 800 to 1200 subjects. Subproject 2 will explore in 400 subjects the genetics of glucose metabolism, hostility, and cardiovascular disease risk factors. Subproject 3 will examine the genetics, hostility and biology of stress in daily life in 400 probands and one sibling for every proband.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Manifestations of the metabolic syndrome
Measured: 6 weeks
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 startJul 1986
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (77)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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Redford B Williams, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005314
- Sponsor's protocol ID
- Pro00008338
- Other IDs
- P01HL036587
- Status last verified
- Feb 2015
- First submitted
- 25 May 2000
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Suarez EC, Shiller AD, Kuhn CM, Schanberg S, Williams RB Jr, Zimmermann EA. The relationship between hostility and beta-adrenergic receptor physiology in health young males. Psychosom Med. 1997 Sep-Oct;59(5):481-7. doi: 10.1097/00006842-199709000-00004.
PubMed 9316180Williams RB. The role of psychosocial factors in human disease: lessons from animal models. Acta Physiol Scand Suppl. 1997;640:100-2.
PubMed 9401617Suarez EC, Kuhn CM, Schanberg SM, Williams RB Jr, Zimmermann EA. Neuroendocrine, cardiovascular, and emotional responses of hostile men: the role of interpersonal challenge. Psychosom Med. 1998 Jan-Feb;60(1):78-88. doi: 10.1097/00006842-199801000-00017.
PubMed 9492244Muranaka M, Monou H, Suzuki J, Lane JD, Anderson NB, Kuhn CM, Schanberg SM, McCown N, Williams RB Jr. Physiological responses to catecholamine infusions in type A and type B men. Health Psychol. 1988;7 Suppl:145-63.
PubMed 2854049Barefoot JC, Peterson BL, Harrell FE Jr, Hlatky MA, Pryor DB, Haney TL, Blumenthal JA, Siegler IC, Williams RB Jr. Type A behavior and survival: a follow-up study of 1,467 patients with coronary artery disease. Am J Cardiol. 1989 Sep 1;64(8):427-32. doi: 10.1016/0002-9149(89)90416-5.
PubMed 2773785Barefoot JC, Dodge KA, Peterson BL, Dahlstrom WG, Williams RB Jr. The Cook-Medley hostility scale: item content and ability to predict survival. Psychosom Med. 1989 Jan-Feb;51(1):46-57. doi: 10.1097/00006842-198901000-00005.
PubMed 2928460Williams RB Jr. Refining the type A hypothesis: emergence of the hostility complex. Am J Cardiol. 1987 Dec 28;60(18):27J-32J. doi: 10.1016/0002-9149(87)90680-1.
PubMed 3321966Barefoot JC, Siegler IC, Nowlin JB, Peterson BL, Haney TL, Williams RB Jr. Suspiciousness, health, and mortality: a follow-up study of 500 older adults. Psychosom Med. 1987 Sep-Oct;49(5):450-7. doi: 10.1097/00006842-198709000-00002.
PubMed 3671634Suarez EC, Williams RB Jr. Situational determinants of cardiovascular and emotional reactivity in high and low hostile men. Psychosom Med. 1989 Jul-Aug;51(4):404-18. doi: 10.1097/00006842-198907000-00004.
PubMed 2772105Williams RB Jr, Barefoot JC, Haney TL, Harrell FE Jr, Blumenthal JA, Pryor DB, Peterson B. Type A behavior and angiographically documented coronary atherosclerosis in a sample of 2,289 patients. Psychosom Med. 1988 Mar-Apr;50(2):139-52. doi: 10.1097/00006842-198803000-00004.
PubMed 3375404Barefoot JC, Beckham JC, Haney TL, Siegler IC, Lipkus IM. Age differences in hostility among middle-aged and older adults. Psychol Aging. 1993 Mar;8(1):3-9. doi: 10.1037//0882-7974.8.1.3.
PubMed 8461112Barefoot JC. Keeping conflicting findings in perspective: the case of hostility and health. Mayo Clin Proc. 1993 Feb;68(2):192-3. doi: 10.1016/s0025-6196(12)60170-0. No abstract available.
PubMed 8423701Mark DB, Lam LC, Lee KL, Clapp-Channing NE, Williams RB, Pryor DB, Califf RM, Hlatky MA. Identification of patients with coronary disease at high risk for loss of employment. A prospective validation study. Circulation. 1992 Nov;86(5):1485-94. doi: 10.1161/01.cir.86.5.1485.
PubMed 1423962Barefoot JC, Beckham JC, Peterson BL, Haney TL, Williams RB Jr. Measures of neuroticism and disease status in coronary angiography patients. J Consult Clin Psychol. 1992 Feb;60(1):127-32. doi: 10.1037//0022-006x.60.1.127.
PubMed 1556275Barefoot JC, Peterson BL, Dahlstrom WG, Siegler IC, Anderson NB, Williams RB Jr. Hostility patterns and health implications: correlates of Cook-Medley Hostility Scale scores in a national survey. Health Psychol. 1991;10(1):18-24. doi: 10.1037//0278-6133.10.1.18.
PubMed 2026126
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Factors in Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00005314
- Acronym / sponsor ID
- Pro00008338
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1986
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- 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 elucidate the role of biobehavioral factors in the etiology, pathogenesis and course of coronary heart disease (CHD) and to use this knowledge to devise more effective prevention, treatment and rehabilitation approaches.
Detailed description
BACKGROUND:
The integrating theme of the study is that hostility affects both behaviors and biologic functions in ways that increase the risks of developing coronary atherosclerosis or suffering an acute CHD event. Disciplines involved include psychology, internal medicine, cardiology, psychiatry, pharmacology, biostatistics, epidemiology, and molecular biology.
DESIGN NARRATIVE:
There were five subprojects in the original program project grant. Subproject 1 examined the social, behavioral and biologic concommitants of both natural and experimental interpersonal conflicts as a function of multimodal hostility assessments. Subproject 2 examined the role of hostility and social support in survival among CHD patients and attempted to identify the behavioral mediators of survival effects. Subproject 4 evaluated the effects of hostility, both alone and jointly with risk factors and social factors, on CHD incidence in over 5,000 participants in the University of North Carolina Alumni Heart Study. Subproject 5 evaluated the effects of age, smoking, lipids, and adrenergic receptors on physiologic reactivity of hostile and nonhostile men to anger induced by interpersonal challenges in the lab as well as the events of daily life. Subproject 7 extended the evaluation of anger-associated biologic reactivity in hostile and nonhostile persons by studying biobehavioral responses of 200 women employed in a real world high stress work situation; it also evaluated the impact of a stress management intervention designed to reduce anger on biobehavioral reactivity in these same employees.
The study was renewed in fiscal year (FY) 1997 to expand the primary focus on hostility to include a set of psychosocial, behavioral, and biological characteristics that increased coronary heart disease risk and appeared to cluster in certain individuals and groups, especially those low in socioeconomic status (SES). Subproject 1 examined in approximately 360 subjects the synergistic effects of SES and psychosocial risk factors such as depression, hostility, and social isolation on biological and behavioral factors suspected or known to contribute to atherogenesis. Subproject 2 evaluated the role of the central nervous system serotonin function as a potential mediator of the clustering of health-damaging psychosocial and biobehavioral characteristics in the same individuals and low SES groups. Subproject 3, the Psychosocial Risk for Cardiovascular Disease in Youth Project (PRCVDYP), used three ongoing general population studies of youth as a basis for examining the development of psychosocial risk for cardiovascular disease. The investigators hypothesized that low SES youth would exhibit, in addition to increased levels of the psychosocial and behavioral risk factors under study, increased sympathetic nervous system tone and reactivity to mental challenge, as well as decreased peripheral nervous system tone. They also hypothesized that depression, social isolation, and harsh parenting will interact with low SES to increase cardiovascular disease risk. Subproject 4 used a rat model to investigate early experience, serotonin and adult function.
The study was renewed in FY 2004 and includes three subprojects. Subproject 1 will determine the role of gene-environment interactions in the expression of psychosocial and biobehavioral risk factors for cardiovascular disease. Variants will be identified in candidate genes and chromosomal loci that are associated with the endophenotypes of hostility, personality, other psychosocial risk factors, health behaviors, and the following responses to rest and stress -- cardiovascular and neuroendocrine function, platelet activation and serotonin transporter function, circulatory inflammatory markers and the tendency of all of these characteristics to cluster in the same individuals and low socioeconomic groups. A total of 400 probands (half African American, half Caucasian, half women) and at least one sibling for each proband will be recruited for a total of 800 to 1200 subjects. Subproject 2 will explore in 400 subjects the genetics of glucose metabolism, hostility, and cardiovascular disease risk factors. Subproject 3 will examine the genetics, hostility and biology of stress in daily life in 400 probands and one sibling for every proband.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy normal volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Manifestations of the metabolic syndrome
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Background: PubMed 9316180Suarez EC, Shiller AD, Kuhn CM, Schanberg S, Williams RB Jr, Zimmermann EA. The relationship between hostility and beta-adrenergic receptor physiology in health young males. Psychosom Med. 1997 Sep-Oct;59(5):481-7. doi: 10.1097/00006842-199709000-00004.
- Background: PubMed 9401617Williams RB. The role of psychosocial factors in human disease: lessons from animal models. Acta Physiol Scand Suppl. 1997;640:100-2.
- Background: PubMed 9492244Suarez EC, Kuhn CM, Schanberg SM, Williams RB Jr, Zimmermann EA. Neuroendocrine, cardiovascular, and emotional responses of hostile men: the role of interpersonal challenge. Psychosom Med. 1998 Jan-Feb;60(1):78-88. doi: 10.1097/00006842-199801000-00017.
- Background: PubMed 2854049Muranaka M, Monou H, Suzuki J, Lane JD, Anderson NB, Kuhn CM, Schanberg SM, McCown N, Williams RB Jr. Physiological responses to catecholamine infusions in type A and type B men. Health Psychol. 1988;7 Suppl:145-63.
- Background: PubMed 2773785Barefoot JC, Peterson BL, Harrell FE Jr, Hlatky MA, Pryor DB, Haney TL, Blumenthal JA, Siegler IC, Williams RB Jr. Type A behavior and survival: a follow-up study of 1,467 patients with coronary artery disease. Am J Cardiol. 1989 Sep 1;64(8):427-32. doi: 10.1016/0002-9149(89)90416-5.
- Background: PubMed 2928460Barefoot JC, Dodge KA, Peterson BL, Dahlstrom WG, Williams RB Jr. The Cook-Medley hostility scale: item content and ability to predict survival. Psychosom Med. 1989 Jan-Feb;51(1):46-57. doi: 10.1097/00006842-198901000-00005.
- Background: PubMed 3321966Williams RB Jr. Refining the type A hypothesis: emergence of the hostility complex. Am J Cardiol. 1987 Dec 28;60(18):27J-32J. doi: 10.1016/0002-9149(87)90680-1.
- Background: PubMed 3671634Barefoot JC, Siegler IC, Nowlin JB, Peterson BL, Haney TL, Williams RB Jr. Suspiciousness, health, and mortality: a follow-up study of 500 older adults. Psychosom Med. 1987 Sep-Oct;49(5):450-7. doi: 10.1097/00006842-198709000-00002.
- Background: PubMed 2772105Suarez EC, Williams RB Jr. Situational determinants of cardiovascular and emotional reactivity in high and low hostile men. Psychosom Med. 1989 Jul-Aug;51(4):404-18. doi: 10.1097/00006842-198907000-00004.
- Background: PubMed 3375404Williams RB Jr, Barefoot JC, Haney TL, Harrell FE Jr, Blumenthal JA, Pryor DB, Peterson B. Type A behavior and angiographically documented coronary atherosclerosis in a sample of 2,289 patients. Psychosom Med. 1988 Mar-Apr;50(2):139-52. doi: 10.1097/00006842-198803000-00004.
- Background: PubMed 8461112Barefoot JC, Beckham JC, Haney TL, Siegler IC, Lipkus IM. Age differences in hostility among middle-aged and older adults. Psychol Aging. 1993 Mar;8(1):3-9. doi: 10.1037//0882-7974.8.1.3.
- Background: PubMed 8423701Barefoot JC. Keeping conflicting findings in perspective: the case of hostility and health. Mayo Clin Proc. 1993 Feb;68(2):192-3. doi: 10.1016/s0025-6196(12)60170-0. No abstract available.
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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.
Redford B Williams, M.D. principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Manifestations of the metabolic syndrome (time frame: 6 weeks). 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 NCT00005314, which also lists 77 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 13 Mar 2015.