Cardiovascular DiseasesNCT00005413
Stroke Risk in the NAS-NRC Twin Registry
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate stroke risk using the National Academy of Sciences Twin Registry. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Accident, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Sep 1993
- 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 investigate stroke risk using the National Academy of Sciences Twin Registry.
Read the detailed description
BACKGROUND:
The epidemiology and common risk factors for cerebrovascular disease have been well documented by cross-sectional and longitudinal population surveys. These studies have generally involved unrelated individuals with little information on family history. Despite a significant role in cardiovascular risk, few studies have investigated familial contributions to stroke risk, and its importance was unknown. Recognition of the importance of hereditary influences on vascular disease of the heart has contributed, in large part, to the current emphasis on the molecular biology of vascular disease and a more balanced view that recognized both genetic and environmental influences on coronary artery disease. Twin studies represented a simple and uniquely powerful tool for analyzing genetic and environmental contributions to complex human phenotypes. Studies of cardiovascular risk have shown the importance of heritable factors, and it was hypothesized that similar genetic factors played a role in development of stroke.
With improved understanding of stroke risk factors (both genetic and environmental), early prevention measures can begin in high risk groups as early as childhood, an approach already applied to cardiovascular disease. Demonstration of a significant heritable risk for stroke should also prompt and help direct, further investigation into the molecular mechanisms of the genetic influences on stroke and may identify new approaches for stroke prevention and treatment, as it has for cardiovascular disease.
DESIGN NARRATIVE:
The twins have been surveyed periodically over the past two decades, most recently in 1985. Information obtained included questions on vascular risk factors, myocardial disease, and stroke. An analysis was made on an estimation of heritable risk. A comparison was made between monozygotic (MZ) and dizygotic (DZ) twins. If genes influenced the prevalence of stroke, there should have been more MZ twin pairs with stroke. Measures of concordance and heritability were used to estimate the size of the genetic contribution. Secondary analyses focussed on compound risk factors (e.g. hypertension and diabetes), less well documented risk factors (e.g. diet and personality), and the heritability of individual stroke risk factors.
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, Cerebrovascular Accident, Myocardial Infarction, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Stroke, Myocardial Infarction, 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 startSep 1991
- Study completionSep 1993
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
- Investigators
- Lawrence Brass, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005413
- Sponsor's protocol ID
- 4331
- Other IDs
- R03HL047451
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Brass LM, Hartigan PM, Page WF, Concato J. Importance of cerebrovascular disease in studies of myocardial infarction. Stroke. 1996 Jul;27(7):1173-6.
PubMed 8685923Brass LM. The design and appraisal of randomized clinical trials in cerebrovascular disease and CNS trauma. Res Publ Assoc Res Nerv Ment Dis. 1993;71:239-63. No abstract available.
PubMed 8417468
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Risk in the NAS-NRC Twin Registry
- ClinicalTrials.gov ID
- NCT00005413
- Acronym / sponsor ID
- 4331
- Conditions
- Cardiovascular Diseases, Cerebrovascular Accident, Myocardial Infarction, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1991
- Study completion
- Sep 1993 (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 investigate stroke risk using the National Academy of Sciences Twin Registry.
Detailed description
BACKGROUND:
The epidemiology and common risk factors for cerebrovascular disease have been well documented by cross-sectional and longitudinal population surveys. These studies have generally involved unrelated individuals with little information on family history. Despite a significant role in cardiovascular risk, few studies have investigated familial contributions to stroke risk, and its importance was unknown. Recognition of the importance of hereditary influences on vascular disease of the heart has contributed, in large part, to the current emphasis on the molecular biology of vascular disease and a more balanced view that recognized both genetic and environmental influences on coronary artery disease. Twin studies represented a simple and uniquely powerful tool for analyzing genetic and environmental contributions to complex human phenotypes. Studies of cardiovascular risk have shown the importance of heritable factors, and it was hypothesized that similar genetic factors played a role in development of stroke.
With improved understanding of stroke risk factors (both genetic and environmental), early prevention measures can begin in high risk groups as early as childhood, an approach already applied to cardiovascular disease. Demonstration of a significant heritable risk for stroke should also prompt and help direct, further investigation into the molecular mechanisms of the genetic influences on stroke and may identify new approaches for stroke prevention and treatment, as it has for cardiovascular disease.
DESIGN NARRATIVE:
The twins have been surveyed periodically over the past two decades, most recently in 1985. Information obtained included questions on vascular risk factors, myocardial disease, and stroke. An analysis was made on an estimation of heritable risk. A comparison was made between monozygotic (MZ) and dizygotic (DZ) twins. If genes influenced the prevalence of stroke, there should have been more MZ twin pairs with stroke. Measures of concordance and heritability were used to estimate the size of the genetic contribution. Secondary analyses focussed on compound risk factors (e.g. hypertension and diabetes), less well documented risk factors (e.g. diet and personality), and the heritability of individual stroke risk factors.
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 13 May 2016.
- Background: PubMed 8685923Brass LM, Hartigan PM, Page WF, Concato J. Importance of cerebrovascular disease in studies of myocardial infarction. Stroke. 1996 Jul;27(7):1173-6.
- Background: PubMed 8417468Brass LM. The design and appraisal of randomized clinical trials in cerebrovascular disease and CNS trauma. Res Publ Assoc Res Nerv Ment Dis. 1993;71:239-63. No abstract available.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Lawrence Brass
Yale University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, 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 13 May 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 NCT00005413, 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 13 May 2016.