Cardiovascular DiseasesNCT00005538
CHD Risk, Behavioral Stress and Reproductive Hormones
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the effects of behavioral stress and reproductive hormones on coronary heart disease (CHD) risk. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1987to Jun 2000
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the effects of behavioral stress and reproductive hormones on coronary heart disease (CHD) risk.
Read the detailed description
DESIGN NARRATIVE:
The behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in CHD. The ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status. Building on these findings, but also departing from previous efforts in strategy and design, five studies are conducted. Study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge. Using longitudinal designs, Study 2 compares women's stress responses prior to and three months after surgical menopause, whereas Study 3 compares healthy women's stress responses prior to and three months after a "temporary menopause" due to the administration of a GnRH agonist. In both studies, some women after the second testing are administered estrogen replacement therapy and stress responses are again measured. Thus, Studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses. These studies gain significance from the fact that surgical menopause is associated with heightened risk for CHD, whereas estrogen replacement therapy is associated with protection from CHD. Study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class. Social class is included in the design because it is a risk factor for psychological stress and for CHD. The final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Menopause
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
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 1987
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Karen Matthews, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005538
- Sponsor's protocol ID
- 5075
- Other IDs
- R37HL038712
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Raikkonen K, Matthews KA, Flory JD, Owens JF, Gump BB. Effects of optimism, pessimism, and trait anxiety on ambulatory blood pressure and mood during everyday life. J Pers Soc Psychol. 1999 Jan;76(1):104-13. doi: 10.1037//0022-3514.76.1.104.
PubMed 9972556Raikkonen K, Matthews KA, Flory JD, Owens JF. Effects of hostility on ambulatory blood pressure and mood during daily living in healthy adults. Health Psychol. 1999 Jan;18(1):44-53. doi: 10.1037//0278-6133.18.1.44.
PubMed 9925045Matthews KA, Berga SL, Owens JF, Flory JD. Effects of short-term suppression of ovarian hormones on cardiovascular and neuroendocrine reactivity to stress in women. Psychoneuroendocrinology. 1998 May;23(4):307-22. doi: 10.1016/s0306-4530(98)00013-4.
PubMed 9695133Davis MC, Matthews KA. Do gender-relevant characteristics determine cardiovascular reactivity? Match versus mismatch of traits and situation. J Pers Soc Psychol. 1996 Sep;71(3):527-35. doi: 10.1037//0022-3514.71.3.527.
PubMed 8831160Matthews KA, Caggiula AR, McAllister CG, Berga SL, Owens JF, Flory JD, Miller AL. Sympathetic reactivity to acute stress and immune response in women. Psychosom Med. 1995 Nov-Dec;57(6):564-71. doi: 10.1097/00006842-199511000-00009.
PubMed 8600483Stoney CM, Owens JF, Guzick DS, Matthews KA. A natural experiment on the effects of ovarian hormones on cardiovascular risk factors and stress reactivity: bilateral salpingo oophorectomy versus hysterectomy only. Health Psychol. 1997 Jul;16(4):349-58. doi: 10.1037//0278-6133.16.4.349.
PubMed 9237087Patterson SM, Matthews KA, Allen MT, Owens JF. Stress-induced hemoconcentration of blood cells and lipids in healthy women during acute psychological stress. Health Psychol. 1995 Jul;14(4):319-24. doi: 10.1037//0278-6133.14.4.319.
PubMed 7556035Caggiula AR, McAllister CG, Matthews KA, Berga SL, Owens JF, Miller AL. Psychological stress and immunological responsiveness in normally cycling, follicular-stage women. J Neuroimmunol. 1995 Jun;59(1-2):103-11. doi: 10.1016/0165-5728(95)00031-v.
PubMed 7797611Adler N, Matthews K. Health psychology: why do some people get sick and some stay well? Annu Rev Psychol. 1994;45:229-59. doi: 10.1146/annurev.ps.45.020194.001305. No abstract available.
PubMed 8135503Owens JF, Stoney CM, Matthews KA. Menopausal status influences ambulatory blood pressure levels and blood pressure changes during mental stress. Circulation. 1993 Dec;88(6):2794-802. doi: 10.1161/01.cir.88.6.2794.
PubMed 8252693Allen MT, Stoney CM, Owens JF, Matthews KA. Hemodynamic adjustments to laboratory stress: the influence of gender and personality. Psychosom Med. 1993 Nov-Dec;55(6):505-17. doi: 10.1097/00006842-199311000-00006.
PubMed 8310111Matthews KA, Owens JF, Allen MT, Stoney CM. Do cardiovascular responses to laboratory stress relate to ambulatory blood pressure levels?: Yes, in some of the people, some of the time. Psychosom Med. 1992 Nov-Dec;54(6):686-97. doi: 10.1097/00006842-199211000-00009.
PubMed 1454963Matthews KA, Rodin J. Pregnancy alters blood pressure responses to psychological and physical challenge. Psychophysiology. 1992 Mar;29(2):232-40. doi: 10.1111/j.1469-8986.1992.tb01691.x.
PubMed 1635966Matthews KA. Myths and realities of the menopause. Psychosom Med. 1992 Jan-Feb;54(1):1-9. doi: 10.1097/00006842-199201000-00001.
PubMed 1553395Matthews KA, Davis MC, Stoney CM, Owens JF, Caggiula AR. Does the gender relevance of the stressor influence sex differences in psychophysiological responses? Health Psychol. 1991;10(2):112-20. doi: 10.1037//0278-6133.10.2.112.
PubMed 2055209
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHD Risk, Behavioral Stress and Reproductive Hormones
- ClinicalTrials.gov ID
- NCT00005538
- Acronym / sponsor ID
- 5075
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1987
- Study completion
- Jun 2000 (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 determine the effects of behavioral stress and reproductive hormones on coronary heart disease (CHD) risk.
Detailed description
DESIGN NARRATIVE:
The behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in CHD. The ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status. Building on these findings, but also departing from previous efforts in strategy and design, five studies are conducted. Study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge. Using longitudinal designs, Study 2 compares women's stress responses prior to and three months after surgical menopause, whereas Study 3 compares healthy women's stress responses prior to and three months after a "temporary menopause" due to the administration of a GnRH agonist. In both studies, some women after the second testing are administered estrogen replacement therapy and stress responses are again measured. Thus, Studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses. These studies gain significance from the fact that surgical menopause is associated with heightened risk for CHD, whereas estrogen replacement therapy is associated with protection from CHD. Study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class. Social class is included in the design because it is a risk factor for psychological stress and for CHD. The final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency.
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 design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 May 2016.
- Background: PubMed 9972556Raikkonen K, Matthews KA, Flory JD, Owens JF, Gump BB. Effects of optimism, pessimism, and trait anxiety on ambulatory blood pressure and mood during everyday life. J Pers Soc Psychol. 1999 Jan;76(1):104-13. doi: 10.1037//0022-3514.76.1.104.
- Background: PubMed 9925045Raikkonen K, Matthews KA, Flory JD, Owens JF. Effects of hostility on ambulatory blood pressure and mood during daily living in healthy adults. Health Psychol. 1999 Jan;18(1):44-53. doi: 10.1037//0278-6133.18.1.44.
- Background: PubMed 9695133Matthews KA, Berga SL, Owens JF, Flory JD. Effects of short-term suppression of ovarian hormones on cardiovascular and neuroendocrine reactivity to stress in women. Psychoneuroendocrinology. 1998 May;23(4):307-22. doi: 10.1016/s0306-4530(98)00013-4.
- Background: PubMed 8831160Davis MC, Matthews KA. Do gender-relevant characteristics determine cardiovascular reactivity? Match versus mismatch of traits and situation. J Pers Soc Psychol. 1996 Sep;71(3):527-35. doi: 10.1037//0022-3514.71.3.527.
- Background: PubMed 8600483Matthews KA, Caggiula AR, McAllister CG, Berga SL, Owens JF, Flory JD, Miller AL. Sympathetic reactivity to acute stress and immune response in women. Psychosom Med. 1995 Nov-Dec;57(6):564-71. doi: 10.1097/00006842-199511000-00009.
- Background: PubMed 9237087Stoney CM, Owens JF, Guzick DS, Matthews KA. A natural experiment on the effects of ovarian hormones on cardiovascular risk factors and stress reactivity: bilateral salpingo oophorectomy versus hysterectomy only. Health Psychol. 1997 Jul;16(4):349-58. doi: 10.1037//0278-6133.16.4.349.
- Background: PubMed 7556035Patterson SM, Matthews KA, Allen MT, Owens JF. Stress-induced hemoconcentration of blood cells and lipids in healthy women during acute psychological stress. Health Psychol. 1995 Jul;14(4):319-24. doi: 10.1037//0278-6133.14.4.319.
- Background: PubMed 7797611Caggiula AR, McAllister CG, Matthews KA, Berga SL, Owens JF, Miller AL. Psychological stress and immunological responsiveness in normally cycling, follicular-stage women. J Neuroimmunol. 1995 Jun;59(1-2):103-11. doi: 10.1016/0165-5728(95)00031-v.
- Background: PubMed 8135503Adler N, Matthews K. Health psychology: why do some people get sick and some stay well? Annu Rev Psychol. 1994;45:229-59. doi: 10.1146/annurev.ps.45.020194.001305. No abstract available.
- Background: PubMed 8252693Owens JF, Stoney CM, Matthews KA. Menopausal status influences ambulatory blood pressure levels and blood pressure changes during mental stress. Circulation. 1993 Dec;88(6):2794-802. doi: 10.1161/01.cir.88.6.2794.
- Background: PubMed 8310111Allen MT, Stoney CM, Owens JF, Matthews KA. Hemodynamic adjustments to laboratory stress: the influence of gender and personality. Psychosom Med. 1993 Nov-Dec;55(6):505-17. doi: 10.1097/00006842-199311000-00006.
- Background: PubMed 1454963Matthews KA, Owens JF, Allen MT, Stoney CM. Do cardiovascular responses to laboratory stress relate to ambulatory blood pressure levels?: Yes, in some of the people, some of the time. Psychosom Med. 1992 Nov-Dec;54(6):686-97. doi: 10.1097/00006842-199211000-00009.
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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.
Karen Matthews
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
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 May 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005538, which also lists 24 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 May 2016.