Vascular DiseasesNCT00062777
The Framingham Study: Examining DNA Markers and Links to Diseases
An observational study of Vascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research. The purpose of this study is to support this national resource by aiding in its research capacity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Diseases
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2003to 16 Jun 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study population will include the members of the 330 Framingham Study families with genome scan.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Genome-Wide Scan for Quantitative Trait Loci of Hematocrit - A Framingham Study
Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research.
The purpose of this study is to support this national resource by aiding in its research capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine DNA and its relationship to risk of developing these disease and health conditions.
Approximately 330 families have participated in the Framingham Study. Participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. During the exam, the Framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. Participants will also be asked to complete a questionnaire at home regarding dietary and health habits.
Read the detailed description
Many studies have shown that hematocrit (HCT) levels are associated with cerebrovascular disease, cardiovascular disease (CVD), peripheral vascular disease, as well as all-cause mortality. Twin studies have shown that HCT variation is largely determined by genetic factors with heritability estimated as 40% - 65%. So far, no linkage analysis in humans between HCT and DNA markers have been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in controlling HCT levels. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in 330 families. HCT was measured in the original cohort and Framingham offspring. These data provide us the opportunity to undertake linkage analyses using variance component method to map quantitative trait loci (QTL) of HCT.
- Conditions
- Vascular Diseases
- Keywords
- Genetics, Populations, CVD Risk, Gene Mapping, Epidemiology, Framingham Study, Vascular Diseases
- Medical subject headings
- Vascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2003 (estimated)
- Study start12 Jun 2003
- Study completion16 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular 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
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062777
- Sponsor's protocol ID
- 030219
- Other IDs
- 03-H-0219
- Status last verified
- 16 Jun 2011
- First submitted
- 13 Jun 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genome-Wide Scan for Quantitative Trait Loci of Hematocrit - A Framingham Study
- ClinicalTrials.gov ID
- NCT00062777
- Acronym / sponsor ID
- 030219
- Conditions
- Vascular Diseases
- Keywords
- Genetics, Populations, CVD Risk, Gene Mapping, Epidemiology, Framingham Study, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 12 Jun 2003
- Study completion
- 16 Jun 2011
- First posted
- 16 Jun 2003 (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.
Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research.
The purpose of this study is to support this national resource by aiding in its research capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine DNA and its relationship to risk of developing these disease and health conditions.
Approximately 330 families have participated in the Framingham Study. Participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. During the exam, the Framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. Participants will also be asked to complete a questionnaire at home regarding dietary and health habits.
Detailed description
Many studies have shown that hematocrit (HCT) levels are associated with cerebrovascular disease, cardiovascular disease (CVD), peripheral vascular disease, as well as all-cause mortality. Twin studies have shown that HCT variation is largely determined by genetic factors with heritability estimated as 40% - 65%. So far, no linkage analysis in humans between HCT and DNA markers have been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in controlling HCT levels. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in 330 families. HCT was measured in the original cohort and Framingham offspring. These data provide us the opportunity to undertake linkage analyses using variance component method to map quantitative trait loci (QTL) of HCT.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study population will include the members of the 330 Framingham Study families with genome scan.
Key exclusion criteria (0 listed)
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 2 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 2 Jul 2017.