Cardiovascular DiseasesNCT00005224
Gender Response To Coronary Risk
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine sex differences in behavioral and psychosocial variables such as occupation, Type A behavior, and hostility as they related to primary coronary risk factors. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1988to Mar 1990
- 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 examine sex differences in behavioral and psychosocial variables such as occupation, Type A behavior, and hostility as they related to primary coronary risk factors.
Read the detailed description
BACKGROUND:
Although coronary heart disease is a major factor in morbidity and mortality in both sexes, most studies prior to 1988 when the study was initiated focused on men and overlooked the magnitude of the problem in women. Coronary heart disease mortality and morbidity rates are higher in men than in women, accounting for 41 percent of the sex difference in overall mortality in the United States. Women's advantage, however, does not seem to be stable over time nor universal. For example, in 1920, the age adjusted ratio of male to female coronary heart disease deaths was approximately equal, but between 1975 and 1978, it has increased to a level of 2.47 in the United States. Also, sex mortality ratios for heart disease differ widely across countries ranging from 5/1 in Finland to 1.87/1 in Yugoslavia. Thus, relying on biological differences alone when explaining this sex differential is not convincing.
Based on Framingham data, among the most important risk factors predicting coronary heart disease in both women and men are--aside from age--cholesterol, cigarette smoking, and blood pressure. Consistent with the observation that men are more likely to fall victim to coronary heart disease than women is the fact that they also exhibit higher levels of these risk factors when compared to women, at least up to the age of 45. Standardization of risk factor levels and controlling for both levels of risk factors on coronary heart disease probabilities eliminated the sex differential in 45 to 54 year olds of the Framingham Study. However, among the 55 to 74 year olds, the sex differential was not due to differences in levels or impact of the risk factors. It was conceivable that the sex mortality differential at the older ages was due to the sex differential in primary coronary risk factors at the younger ages.
Of particular interest was the fact that the primary risk factors appeared to be influenced by behavior. It was possible that gender differences in behavior might explain gender differences in primary coronary risk factors. Alternatively, there was some evidence that the primary coronary risk factors were not solely responsible for the etiology of coronary heart disease. Gender differences in psychosocial variables, such as Type A behavior, hostility, and occupational stress that might play independent roles in the etiology of coronary heart disease had not been systematically investigated.
DESIGN NARRATIVE:
Gender differences in primary risk factors were determined, with all analyses being controlled for body mass since men score higher on body mass index than women and body mass is related to levels of primary coronary risk factors. One-way analyses of covariance were performed for plasma lipids and lipoproteins, blood pressure, and heart rate. Gender differences in psychosocial variables associated with coronary risk were investigated. Analyses were performed on primary coronary risk factors at baseline in order to investigate the relationships of occupational characteristics such as demand and control with age and body mass index. Covariance analyses were performed for Type A/Type B by high and low occupational control and by high and low demand for each sex. The role of parental history of heart disease, Type A behavior and smoking in elevated primary coronary risk factors among oral contraceptive users were also investigated.
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, Heart Diseases, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
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 startApr 1988
- Study completionMar 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Gerdi Weidner, State University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005224
- Sponsor's protocol ID
- 1103
- Other IDs
- R01HL040368
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Weidner G, Friend R, Ficarrotto TJ, Mendell NR. Hostility and cardiovascular reactivity to stress in women and men. Psychosom Med. 1989 Jan-Feb;51(1):36-45. doi: 10.1097/00006842-198901000-00004.
PubMed 2928459Emmons KM, Weidner G, Collins RL. Smoking cessation and cardiovascular reactivity to stress. J Behav Med. 1989 Dec;12(6):587-98. doi: 10.1007/BF00844827.
PubMed 2634111Weidner G, Helmig L. Cardiovascular stress reactivity and mood during the menstrual cycle. Women Health. 1990;16(3-4):5-21. doi: 10.1300/J013v16n03_02.
PubMed 2267809Weidner G, Connor SL, Chesney MA, Burns JW, Connor WE, Matarazzo JD, Mendell NR. Sex differences in high density lipoprotein cholesterol among low-level alcohol consumers. Circulation. 1991 Jan;83(1):176-80. doi: 10.1161/01.cir.83.1.176.
PubMed 1984880Hutt J, Weidner G. The effects of task demand and decision latitude on cardiovascular reactivity to stress. Behav Med. 1993 Winter;18(4):181-8. doi: 10.1080/08964289.1993.9939113.
PubMed 8461490Weidner G, Connor SL, Hollis JF, Connor WE. Improvements in hostility and depression in relation to dietary change and cholesterol lowering. The Family Heart Study. Ann Intern Med. 1992 Nov 15;117(10):820-3. doi: 10.7326/0003-4819-117-10-820.
PubMed 1416556Emmons KM, Weidner G, Foster WM, Collins RL. Improvement in pulmonary function following smoking cessation. Addict Behav. 1992;17(4):301-6. doi: 10.1016/0306-4603(92)90036-u.
PubMed 1502964Weidner G, Hutt J, Connor SL, Mendell NR. Family stress and coronary risk in children. Psychosom Med. 1992 Jul-Aug;54(4):471-9. doi: 10.1097/00006842-199207000-00009.
PubMed 1502288
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
- Gender Response To Coronary Risk
- ClinicalTrials.gov ID
- NCT00005224
- Acronym / sponsor ID
- 1103
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1988
- Study completion
- Mar 1990 (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 examine sex differences in behavioral and psychosocial variables such as occupation, Type A behavior, and hostility as they related to primary coronary risk factors.
Detailed description
BACKGROUND:
Although coronary heart disease is a major factor in morbidity and mortality in both sexes, most studies prior to 1988 when the study was initiated focused on men and overlooked the magnitude of the problem in women. Coronary heart disease mortality and morbidity rates are higher in men than in women, accounting for 41 percent of the sex difference in overall mortality in the United States. Women's advantage, however, does not seem to be stable over time nor universal. For example, in 1920, the age adjusted ratio of male to female coronary heart disease deaths was approximately equal, but between 1975 and 1978, it has increased to a level of 2.47 in the United States. Also, sex mortality ratios for heart disease differ widely across countries ranging from 5/1 in Finland to 1.87/1 in Yugoslavia. Thus, relying on biological differences alone when explaining this sex differential is not convincing.
Based on Framingham data, among the most important risk factors predicting coronary heart disease in both women and men are--aside from age--cholesterol, cigarette smoking, and blood pressure. Consistent with the observation that men are more likely to fall victim to coronary heart disease than women is the fact that they also exhibit higher levels of these risk factors when compared to women, at least up to the age of 45. Standardization of risk factor levels and controlling for both levels of risk factors on coronary heart disease probabilities eliminated the sex differential in 45 to 54 year olds of the Framingham Study. However, among the 55 to 74 year olds, the sex differential was not due to differences in levels or impact of the risk factors. It was conceivable that the sex mortality differential at the older ages was due to the sex differential in primary coronary risk factors at the younger ages.
Of particular interest was the fact that the primary risk factors appeared to be influenced by behavior. It was possible that gender differences in behavior might explain gender differences in primary coronary risk factors. Alternatively, there was some evidence that the primary coronary risk factors were not solely responsible for the etiology of coronary heart disease. Gender differences in psychosocial variables, such as Type A behavior, hostility, and occupational stress that might play independent roles in the etiology of coronary heart disease had not been systematically investigated.
DESIGN NARRATIVE:
Gender differences in primary risk factors were determined, with all analyses being controlled for body mass since men score higher on body mass index than women and body mass is related to levels of primary coronary risk factors. One-way analyses of covariance were performed for plasma lipids and lipoproteins, blood pressure, and heart rate. Gender differences in psychosocial variables associated with coronary risk were investigated. Analyses were performed on primary coronary risk factors at baseline in order to investigate the relationships of occupational characteristics such as demand and control with age and body mass index. Covariance analyses were performed for Type A/Type B by high and low occupational control and by high and low demand for each sex. The role of parental history of heart disease, Type A behavior and smoking in elevated primary coronary risk factors among oral contraceptive users were also investigated.
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 2928459Weidner G, Friend R, Ficarrotto TJ, Mendell NR. Hostility and cardiovascular reactivity to stress in women and men. Psychosom Med. 1989 Jan-Feb;51(1):36-45. doi: 10.1097/00006842-198901000-00004.
- Background: PubMed 2634111Emmons KM, Weidner G, Collins RL. Smoking cessation and cardiovascular reactivity to stress. J Behav Med. 1989 Dec;12(6):587-98. doi: 10.1007/BF00844827.
- Background: PubMed 2267809Weidner G, Helmig L. Cardiovascular stress reactivity and mood during the menstrual cycle. Women Health. 1990;16(3-4):5-21. doi: 10.1300/J013v16n03_02.
- Background: PubMed 1984880Weidner G, Connor SL, Chesney MA, Burns JW, Connor WE, Matarazzo JD, Mendell NR. Sex differences in high density lipoprotein cholesterol among low-level alcohol consumers. Circulation. 1991 Jan;83(1):176-80. doi: 10.1161/01.cir.83.1.176.
- Background: PubMed 8461490Hutt J, Weidner G. The effects of task demand and decision latitude on cardiovascular reactivity to stress. Behav Med. 1993 Winter;18(4):181-8. doi: 10.1080/08964289.1993.9939113.
- Background: PubMed 1416556Weidner G, Connor SL, Hollis JF, Connor WE. Improvements in hostility and depression in relation to dietary change and cholesterol lowering. The Family Heart Study. Ann Intern Med. 1992 Nov 15;117(10):820-3. doi: 10.7326/0003-4819-117-10-820.
- Background: PubMed 1502964Emmons KM, Weidner G, Foster WM, Collins RL. Improvement in pulmonary function following smoking cessation. Addict Behav. 1992;17(4):301-6. doi: 10.1016/0306-4603(92)90036-u.
- Background: PubMed 1502288Weidner G, Hutt J, Connor SL, Mendell NR. Family stress and coronary risk in children. Psychosom Med. 1992 Jul-Aug;54(4):471-9. doi: 10.1097/00006842-199207000-00009.
Related trials for Cardiovascular Diseases
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
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.
Gerdi Weidner
State University of New York
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, 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 NCT00005224, which also lists 8 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.