Cardiovascular DiseasesNCT00005428
Familial Aggregation of Stress Response
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To perform data analyses on the familial aggregation of the stress response as it relates to hypertension. 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, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1993to Jul 1995
- 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 perform data analyses on the familial aggregation of the stress response as it relates to hypertension.
Read the detailed description
BACKGROUND:
Given recent advances in the analyses of genetic epidemiologic data, the database presented a unique opportunity to address timely issues pertinent to the contribution of genetic and environmental factors to individual differences in cardiovascular reactivity.
DESIGN NARRATIVE:
Secondary data analyses were performed on family data obtained in an ongoing hypertension genetic study conducted at the University of Utah with Roger R. Williams as principal investigator. The available data represented one of the largest studies of cardiovascular reactivity among genetically related individuals. During 1981-83, a total of 2,548 subjects, members of 98 extended families (multiple generations and multiple nuclear families) participated in an extensive cardiovascular examination and were assessed on a comprehensive battery of cardiovascular tests. Annual follow-up questionnaires obtained information about the onset of hypertension and new medication prescribed. In 1991-92, a follow-up exam was conducted on 1,500 subjects.
The data analysis attempted to confirm or refute hypotheses postulating a reactivity-hypertension association; investigated whether there was a sex limitation in the genetic and environmental determinants of reactivity; explored genotype-by-age interactions in the control of reactivity;and determined whether there was shared genetic and/or environmental variance between reactivity and other recognized cardiovascular risk factors such as obesity or lipids.
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, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
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 startAug 1993
- Study completionJul 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- NCT00005428
- Sponsor's protocol ID
- 4346
- Other IDs
- R03HL050679
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Cheng LS, Carmelli D, Hunt SC, Williams RR. Segregation analysis of cardiovascular reactivity to laboratory stressors. Genet Epidemiol. 1997;14(1):35-49. doi: 10.1002/(SICI)1098-2272(1997)14:13.0.CO;2-4.
PubMed 9055060Cheng LS, Carmelli D, Hunt SC, Williams RR. Evidence for a major gene influencing 7-year increases in diastolic blood pressure with age. Am J Hum Genet. 1995 Nov;57(5):1169-77.
PubMed 7485169
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Aggregation of Stress Response
- ClinicalTrials.gov ID
- NCT00005428
- Acronym / sponsor ID
- 4346
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1993
- Study completion
- Jul 1995 (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 perform data analyses on the familial aggregation of the stress response as it relates to hypertension.
Detailed description
BACKGROUND:
Given recent advances in the analyses of genetic epidemiologic data, the database presented a unique opportunity to address timely issues pertinent to the contribution of genetic and environmental factors to individual differences in cardiovascular reactivity.
DESIGN NARRATIVE:
Secondary data analyses were performed on family data obtained in an ongoing hypertension genetic study conducted at the University of Utah with Roger R. Williams as principal investigator. The available data represented one of the largest studies of cardiovascular reactivity among genetically related individuals. During 1981-83, a total of 2,548 subjects, members of 98 extended families (multiple generations and multiple nuclear families) participated in an extensive cardiovascular examination and were assessed on a comprehensive battery of cardiovascular tests. Annual follow-up questionnaires obtained information about the onset of hypertension and new medication prescribed. In 1991-92, a follow-up exam was conducted on 1,500 subjects.
The data analysis attempted to confirm or refute hypotheses postulating a reactivity-hypertension association; investigated whether there was a sex limitation in the genetic and environmental determinants of reactivity; explored genotype-by-age interactions in the control of reactivity;and determined whether there was shared genetic and/or environmental variance between reactivity and other recognized cardiovascular risk factors such as obesity or lipids.
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 16 Mar 2016.
- Background: PubMed 9055060Cheng LS, Carmelli D, Hunt SC, Williams RR. Segregation analysis of cardiovascular reactivity to laboratory stressors. Genet Epidemiol. 1997;14(1):35-49. doi: 10.1002/(SICI)1098-2272(1997)14:13.0.CO;2-4.
- Background: PubMed 7485169Cheng LS, Carmelli D, Hunt SC, Williams RR. Evidence for a major gene influencing 7-year increases in diastolic blood pressure with age. Am J Hum Genet. 1995 Nov;57(5):1169-77.
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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 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 16 Mar 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 NCT00005428, which also lists 2 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 16 Mar 2016.