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CHD Risk, Behavioral Stress and Reproductive Hormones

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005538
    Brief Title
    CHD Risk, Behavioral Stress and Reproductive Hormones
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    August 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1987 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2000 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Disease, Heart Diseases, Menopause

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen Matthews
    Organizational Affiliation
    University of Pittsburgh

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9972556
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9925045
    Citation
    Raikkonen 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. Erratum In: Health Psychol 1999 May;18(3):228.
    Results Reference
    background
    PubMed Identifier
    9695133
    Citation
    Matthews 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.
    Results Reference
    background
    PubMed Identifier
    8831160
    Citation
    Davis 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.
    Results Reference
    background
    PubMed Identifier
    8600483
    Citation
    Matthews 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.
    Results Reference
    background
    PubMed Identifier
    9237087
    Citation
    Stoney 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.
    Results Reference
    background
    PubMed Identifier
    7556035
    Citation
    Patterson 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.
    Results Reference
    background
    PubMed Identifier
    7797611
    Citation
    Caggiula 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.
    Results Reference
    background
    PubMed Identifier
    8135503
    Citation
    Adler 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.
    Results Reference
    background
    PubMed Identifier
    8252693
    Citation
    Owens 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.
    Results Reference
    background
    PubMed Identifier
    8310111
    Citation
    Allen 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.
    Results Reference
    background
    PubMed Identifier
    1454963
    Citation
    Matthews 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.
    Results Reference
    background
    PubMed Identifier
    1635966
    Citation
    Matthews 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.
    Results Reference
    background
    PubMed Identifier
    1553395
    Citation
    Matthews KA. Myths and realities of the menopause. Psychosom Med. 1992 Jan-Feb;54(1):1-9. doi: 10.1097/00006842-199201000-00001.
    Results Reference
    background
    PubMed Identifier
    2055209
    Citation
    Matthews 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.
    Results Reference
    background
    PubMed Identifier
    2113445
    Citation
    Caggiula AR, Stoney CM, Matthews KA, Owens JF, Davis MC, Rabin BS. T-lymphocyte reactivity during the menstrual cycle in women. Clin Immunol Immunopathol. 1990 Jul;56(1):130-4. doi: 10.1016/0090-1229(90)90177-r.
    Results Reference
    background
    PubMed Identifier
    2247544
    Citation
    Stoney CM, Owens JF, Matthews KA, Davis MC, Caggiula A. Influences of the normal menstrual cycle on physiologic functioning during behavioral stress. Psychophysiology. 1990 Mar;27(2):125-35. doi: 10.1111/j.1469-8986.1990.tb00364.x.
    Results Reference
    background
    PubMed Identifier
    2286182
    Citation
    Davis MC, Matthews KA. Cigarette smoking and oral contraceptive use influence women's lipid, lipoprotein, and cardiovascular responses during stress. Health Psychol. 1990;9(6):717-36. doi: 10.1037//0278-6133.9.6.717.
    Results Reference
    background
    PubMed Identifier
    2756076
    Citation
    Saab PG, Matthews KA, Stoney CM, McDonald RH. Premenopausal and postmenopausal women differ in their cardiovascular and neuroendocrine responses to behavioral stressors. Psychophysiology. 1989 May;26(3):270-80. doi: 10.1111/j.1469-8986.1989.tb01917.x.
    Results Reference
    background
    PubMed Identifier
    10845348
    Citation
    Matthews KA, Raikkonen K, Everson SA, Flory JD, Marco CA, Owens JF, Lloyd CE. Do the daily experiences of healthy men and women vary according to occupational prestige and work strain? Psychosom Med. 2000 May-Jun;62(3):346-53. doi: 10.1097/00006842-200005000-00008.
    Results Reference
    background
    PubMed Identifier
    11714181
    Citation
    Matthews KA, Gump BB, Owens JF. Chronic stress influences cardiovascular and neuroendocrine responses during acute stress and recovery, especially in men. Health Psychol. 2001 Nov;20(6):403-10.
    Results Reference
    background
    PubMed Identifier
    12404194
    Citation
    Powers RW, Majors AK, Lykins DL, Sims CJ, Lain KY, Roberts JM. Plasma homocysteine and malondialdehyde are correlated in an age- and gender-specific manner. Metabolism. 2002 Nov;51(11):1433-8. doi: 10.1053/meta.2002.35587.
    Results Reference
    background
    PubMed Identifier
    12084666
    Citation
    Flory JD, Matthews KA, Sistilli CG, Caggiula AR, Berga SL, Owens JF. Short-term suppression of ovarian function and immune measures in healthy women. Psychoneuroendocrinology. 2002 Aug;27(6):749-68. doi: 10.1016/s0306-4530(01)00078-6.
    Results Reference
    background
    PubMed Identifier
    12082358
    Citation
    Owens JF, Matthews KA, Everson SA. Cognitive function effects of suppressing ovarian hormones in young women. Menopause. 2002 Jul-Aug;9(4):227-35. doi: 10.1097/00042192-200207000-00003.
    Results Reference
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