Cardiovascular DiseasesNCT00005435
Hostility and Pathogenic Mechanisms of Coronary Heart Disease in Women
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the combined effects of hostility, harassment, lipids, and oral contraceptive (0C) use on physiological responses in young and middle-aged premenopausal women. 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 1991to Jun 1997
- 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 combined effects of hostility, harassment, lipids, and oral contraceptive (0C) use on physiological responses in young and middle-aged premenopausal women.
Read the detailed description
BACKGROUND:
Preliminary findings already have shown that, in contrast to women with low scores on the Cook and Medley Hostility (Ho) scale, women with high Ho scores exhibit greater cardiovascular changes to harassment. Additional findings have suggested that oral contraceptive (0C) use may also be associated with increased behaviorally-induced physiological changes, especially in low Ho women. Similarly, higher levels of total serum cholesterol (TSC) have been positively associated with greater stress-induced neurohormonal changes in middle-aged men with high Ho scores.
DESIGN NARRATIVE:
Assessment of autonomic activity took place in the laboratory and during a 24 hour ambulatory measurement period. Hostility was measured with the Cook and Medley Hostility scale. The laboratory assessment helped to determine if high hostility women responded to harassment with greater cardiovascular and neurohormonal changes than low hostility women, and if this relationship was altered by 0C use, lipids, and age. The ambulatory assessment of autonomic activity allowed an exploration of the responses of high and low hostility subjects to daily-life stressors. Several hypothesis were explored: 1) Did harassment produce neuroendocrine as well as cardiovascular hyperreactivity in young women, and did this hyperreactivity generalize from laboratory to real-life? 2) Were the harassment-induced cardiovascular and neuroendocrine changes in young women also present in middle-aged women? 3) To what extent did 0C use modulate the cardiovascular and neuroendocrine responses to harassment in young women, and was 0C use also altering the hostility--related associations between lipids and reactivity? 4) Were the differential lipid-reactivity associations observed in middle-aged men as a function of high and low hostility scores present in women, and, if so, were they modulated by age?
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
- 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 1991
- Study completionJun 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005435
- Sponsor's protocol ID
- 4362
- Other IDs
- R29HL046283
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Harralson TL, Suarez EC, Lawler KA. Cardiovascular reactivity among hostile men and women: the effects of sex and anger suppression. Womens Health. 1997 Summer;3(2):151-64.
PubMed 9332156Suarez EC, Harlan E, Peoples MC, Williams RB Jr. Cardiovascular and emotional responses in women: the role of hostility and harassment. Health Psychol. 1993 Nov;12(6):459-68. doi: 10.1037//0278-6133.12.6.459.
PubMed 8293729Suarez EC. Relations of trait depression and anxiety to low lipid and lipoprotein concentrations in healthy young adult women. Psychosom Med. 1999 May-Jun;61(3):273-9. doi: 10.1097/00006842-199905000-00004.
PubMed 10367605Suarez EC, Bates MP, Harralson TL. The relation of hostility to lipids and lipoproteins in women: evidence for the role of antagonistic hostility. Ann Behav Med. 1998 Spring;20(2):59-63. doi: 10.1007/BF02884449.
PubMed 9989309
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hostility and Pathogenic Mechanisms of Coronary Heart Disease in Women
- ClinicalTrials.gov ID
- NCT00005435
- Acronym / sponsor ID
- 4362
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1991
- Study completion
- Jun 1997 (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 combined effects of hostility, harassment, lipids, and oral contraceptive (0C) use on physiological responses in young and middle-aged premenopausal women.
Detailed description
BACKGROUND:
Preliminary findings already have shown that, in contrast to women with low scores on the Cook and Medley Hostility (Ho) scale, women with high Ho scores exhibit greater cardiovascular changes to harassment. Additional findings have suggested that oral contraceptive (0C) use may also be associated with increased behaviorally-induced physiological changes, especially in low Ho women. Similarly, higher levels of total serum cholesterol (TSC) have been positively associated with greater stress-induced neurohormonal changes in middle-aged men with high Ho scores.
DESIGN NARRATIVE:
Assessment of autonomic activity took place in the laboratory and during a 24 hour ambulatory measurement period. Hostility was measured with the Cook and Medley Hostility scale. The laboratory assessment helped to determine if high hostility women responded to harassment with greater cardiovascular and neurohormonal changes than low hostility women, and if this relationship was altered by 0C use, lipids, and age. The ambulatory assessment of autonomic activity allowed an exploration of the responses of high and low hostility subjects to daily-life stressors. Several hypothesis were explored: 1) Did harassment produce neuroendocrine as well as cardiovascular hyperreactivity in young women, and did this hyperreactivity generalize from laboratory to real-life? 2) Were the harassment-induced cardiovascular and neuroendocrine changes in young women also present in middle-aged women? 3) To what extent did 0C use modulate the cardiovascular and neuroendocrine responses to harassment in young women, and was 0C use also altering the hostility--related associations between lipids and reactivity? 4) Were the differential lipid-reactivity associations observed in middle-aged men as a function of high and low hostility scores present in women, and, if so, were they modulated by age?
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 18 Feb 2016.
- Background: PubMed 9332156Harralson TL, Suarez EC, Lawler KA. Cardiovascular reactivity among hostile men and women: the effects of sex and anger suppression. Womens Health. 1997 Summer;3(2):151-64.
- Background: PubMed 8293729Suarez EC, Harlan E, Peoples MC, Williams RB Jr. Cardiovascular and emotional responses in women: the role of hostility and harassment. Health Psychol. 1993 Nov;12(6):459-68. doi: 10.1037//0278-6133.12.6.459.
- Background: PubMed 10367605Suarez EC. Relations of trait depression and anxiety to low lipid and lipoprotein concentrations in healthy young adult women. Psychosom Med. 1999 May-Jun;61(3):273-9. doi: 10.1097/00006842-199905000-00004.
- Background: PubMed 9989309Suarez EC, Bates MP, Harralson TL. The relation of hostility to lipids and lipoproteins in women: evidence for the role of antagonistic hostility. Ann Behav Med. 1998 Spring;20(2):59-63. doi: 10.1007/BF02884449.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 18 Feb 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 NCT00005435, which also lists 4 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 18 Feb 2016.