Heart DiseasesNCT00037232
Failure Time Methods for Family Disease Studies
An observational study of Heart Diseases and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To develop statistical methodologies to study genetic and environmental factors in cardiovascular disease, using age at onset data from population-based family studies of disease incidence. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2001to Mar 2005
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To develop statistical methodologies to study genetic and environmental factors in cardiovascular disease, using age at onset data from population-based family studies of disease incidence.
Read the detailed description
BACKGROUND:
In the study of chronic diseases, both environmental and genetic factors can be influential. In highly common diseases, such as coronary heart disease, genetic effects may be more influential in determining the age of onset of the disease than in determining whether or not one gets the disease. When sufficient information is available, family studies can help localize possible disease genes on the human chromosome through genetic linkage analysis, and familial aggregation of disease can help separate the effects of inheritance, environment and lifestyle on the risk of disease.
DESIGN NARRATIVE:
The study developed: (1) a general strategy for evaluating the fit of parametric dependence models for familial clustering of ages at disease-onset; (2) a computationally simple method for genetic linkage analysis of age at onset data; (3) application and illustration of recently developed additive frailty models for complex familial dependence structures. Method (1) was applied to a family study of cardiovascular disease and a twin study of appendectomy. Method (2) was applied to ongoing genetic studies conducted at the University of California at San Francisco. Method (3) was applied to a family study of coronary heart disease in Western Australia. Well-documented, user-friendly programs were developed and made publicly available.
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
- Heart Diseases, Cardiovascular Diseases, Coronary Disease
- Medical subject headings
- Heart Diseases, Cardiovascular 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 posted17 May 2002 (estimated)
- Study startApr 2001
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart 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
- David Glidden, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037232
- Sponsor's protocol ID
- 1140
- Other IDs
- R01HL065411
- Status last verified
- May 2005
- First submitted
- 16 May 2002
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Glidden DV. Robust inference for event probabilities with non-Markov event data. Biometrics. 2002 Jun;58(2):361-8. doi: 10.1111/j.0006-341x.2002.00361.x.
PubMed 12071409St Jeor ST, Perumean-Chaney S, Sigman-Grant M, Williams C, Foreyt J. Family-based interventions for the treatment of childhood obesity. J Am Diet Assoc. 2002 May;102(5):640-4. doi: 10.1016/s0002-8223(02)90146-x. No abstract available.
PubMed 12008987Glidden DV, Liang KY, Chiu YF, Pulver AE. Multipoint affected sibpair linkage methods for localizing susceptibility genes of complex diseases. Genet Epidemiol. 2003 Feb;24(2):107-17. doi: 10.1002/gepi.10215.
PubMed 12548672Glidden DV, Liang KY. Ascertainment adjustment in complex diseases. Genet Epidemiol. 2002 Oct;23(3):201-8. doi: 10.1002/gepi.10204.
PubMed 12384971Glidden DV, Vittinghoff E. Modelling clustered survival data from multicentre clinical trials. Stat Med. 2004 Feb 15;23(3):369-88. doi: 10.1002/sim.1599.
PubMed 14748034
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
- Failure Time Methods for Family Disease Studies
- ClinicalTrials.gov ID
- NCT00037232
- Acronym / sponsor ID
- 1140
- Conditions
- Heart Diseases, Cardiovascular 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 2001
- Study completion
- Mar 2005 (actual)
- First posted
- 17 May 2002 (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 develop statistical methodologies to study genetic and environmental factors in cardiovascular disease, using age at onset data from population-based family studies of disease incidence.
Detailed description
BACKGROUND:
In the study of chronic diseases, both environmental and genetic factors can be influential. In highly common diseases, such as coronary heart disease, genetic effects may be more influential in determining the age of onset of the disease than in determining whether or not one gets the disease. When sufficient information is available, family studies can help localize possible disease genes on the human chromosome through genetic linkage analysis, and familial aggregation of disease can help separate the effects of inheritance, environment and lifestyle on the risk of disease.
DESIGN NARRATIVE:
The study developed: (1) a general strategy for evaluating the fit of parametric dependence models for familial clustering of ages at disease-onset; (2) a computationally simple method for genetic linkage analysis of age at onset data; (3) application and illustration of recently developed additive frailty models for complex familial dependence structures. Method (1) was applied to a family study of cardiovascular disease and a twin study of appendectomy. Method (2) was applied to ongoing genetic studies conducted at the University of California at San Francisco. Method (3) was applied to a family study of coronary heart disease in Western Australia. Well-documented, user-friendly programs were developed and made publicly available.
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
- All
- 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 12071409Glidden DV. Robust inference for event probabilities with non-Markov event data. Biometrics. 2002 Jun;58(2):361-8. doi: 10.1111/j.0006-341x.2002.00361.x.
- Background: PubMed 12008987St Jeor ST, Perumean-Chaney S, Sigman-Grant M, Williams C, Foreyt J. Family-based interventions for the treatment of childhood obesity. J Am Diet Assoc. 2002 May;102(5):640-4. doi: 10.1016/s0002-8223(02)90146-x. No abstract available.
- Background: PubMed 12548672Glidden DV, Liang KY, Chiu YF, Pulver AE. Multipoint affected sibpair linkage methods for localizing susceptibility genes of complex diseases. Genet Epidemiol. 2003 Feb;24(2):107-17. doi: 10.1002/gepi.10215.
- Background: PubMed 12384971Glidden DV, Liang KY. Ascertainment adjustment in complex diseases. Genet Epidemiol. 2002 Oct;23(3):201-8. doi: 10.1002/gepi.10204.
- Background: PubMed 14748034Glidden DV, Vittinghoff E. Modelling clustered survival data from multicentre clinical trials. Stat Med. 2004 Feb 15;23(3):369-88. doi: 10.1002/sim.1599.
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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.
David Glidden
University of California at San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Cardiovascular 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 NCT00037232, which also lists 5 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.