Cardiovascular DiseasesNCT00007397
Age, Risk Factors for CVD and Cognitive Functioning
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To relate cardiovascular disease (CHD) risk factors to cognitive performance among middle-aged and elderly men and women over a 10 year longitudinal study period. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Neurologic Manifestations
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2000to Jan 2004
- 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 relate cardiovascular disease (CHD) risk factors to cognitive performance among middle-aged and elderly men and women over a 10 year longitudinal study period.
Read the detailed description
BACKGROUND:
The Framingham Heart Study is a major epidemiological investigation of prospective relationships between risk factors for the development of cardiovascular disease (CVD risk factors) and CVD risk factor outcomes. The Framingham Study and other large, prospective studies have resulted in an extensive literature on the impact of CVD risk factors (including age) and CVD outcomes. Comparatively, there have been many fewer studies of the impact of CVD risk factors on cognitive functioning, and possibly no studies of the effect of objectively measured, competing risk factors on cognitive functioning.
DESIGN NARRATIVE:
Dr. Elias and colleagues used cardiovascular risk factor data from the Framingham Heart Study (N= 2,123) in a prospective design allowing them to relate CVD risk factors (including age and gender) to two outcome measures: (1) level of cognitive performance and (2) change in cognitive performance over a 10 year longitudinal study period. The overall goals were to determine the best multivariate combination of biological and psychosocial risk factors for the prediction of lowered cognitive ability in middle-aged and elderly men and women, and to evaluate the relative impact of age, gender, and other biological and psychosocial risk factors on cognitive functioning.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Neurologic Manifestations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2000 (estimated)
- Study startFeb 2000
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Merrill Elias, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007397
- Sponsor's protocol ID
- 958
- Other IDs
- R43HL065117
- Status last verified
- Dec 2005
- First submitted
- 19 Dec 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Elias MF, Elias PK, Sullivan LM, Wolf PA, D'Agostino RB. Lower cognitive function in the presence of obesity and hypertension: the Framingham heart study. Int J Obes Relat Metab Disord. 2003 Feb;27(2):260-8. doi: 10.1038/sj.ijo.802225.
PubMed 12587008Elias MF, Sullivan LM, D'Agostino RB, Elias PK, Beiser A, Au R, Seshadri S, DeCarli C, Wolf PA. Framingham stroke risk profile and lowered cognitive performance. Stroke. 2004 Feb;35(2):404-9. doi: 10.1161/01.STR.0000103141.82869.77. Epub 2004 Jan 15.
PubMed 14726556Elias PK, Elias MF, D'Agostino RB, Sullivan LM, Wolf PA. Serum cholesterol and cognitive performance in the Framingham Heart Study. Psychosom Med. 2005 Jan-Feb;67(1):24-30. doi: 10.1097/01.psy.0000151745.67285.c2.
PubMed 15673620
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
- Age, Risk Factors for CVD and Cognitive Functioning
- ClinicalTrials.gov ID
- NCT00007397
- Acronym / sponsor ID
- 958
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Feb 2000
- Study completion
- Jan 2004 (actual)
- First posted
- 19 Dec 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 relate cardiovascular disease (CHD) risk factors to cognitive performance among middle-aged and elderly men and women over a 10 year longitudinal study period.
Detailed description
BACKGROUND:
The Framingham Heart Study is a major epidemiological investigation of prospective relationships between risk factors for the development of cardiovascular disease (CVD risk factors) and CVD risk factor outcomes. The Framingham Study and other large, prospective studies have resulted in an extensive literature on the impact of CVD risk factors (including age) and CVD outcomes. Comparatively, there have been many fewer studies of the impact of CVD risk factors on cognitive functioning, and possibly no studies of the effect of objectively measured, competing risk factors on cognitive functioning.
DESIGN NARRATIVE:
Dr. Elias and colleagues used cardiovascular risk factor data from the Framingham Heart Study (N= 2,123) in a prospective design allowing them to relate CVD risk factors (including age and gender) to two outcome measures: (1) level of cognitive performance and (2) change in cognitive performance over a 10 year longitudinal study period. The overall goals were to determine the best multivariate combination of biological and psychosocial risk factors for the prediction of lowered cognitive ability in middle-aged and elderly men and women, and to evaluate the relative impact of age, gender, and other biological and psychosocial risk factors on cognitive functioning.
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 13 May 2016.
- Background: PubMed 12587008Elias MF, Elias PK, Sullivan LM, Wolf PA, D'Agostino RB. Lower cognitive function in the presence of obesity and hypertension: the Framingham heart study. Int J Obes Relat Metab Disord. 2003 Feb;27(2):260-8. doi: 10.1038/sj.ijo.802225.
- Background: PubMed 14726556Elias MF, Sullivan LM, D'Agostino RB, Elias PK, Beiser A, Au R, Seshadri S, DeCarli C, Wolf PA. Framingham stroke risk profile and lowered cognitive performance. Stroke. 2004 Feb;35(2):404-9. doi: 10.1161/01.STR.0000103141.82869.77. Epub 2004 Jan 15.
- Background: PubMed 15673620Elias PK, Elias MF, D'Agostino RB, Sullivan LM, Wolf PA. Serum cholesterol and cognitive performance in the Framingham Heart Study. Psychosom Med. 2005 Jan-Feb;67(1):24-30. doi: 10.1097/01.psy.0000151745.67285.c2.
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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.
Merrill Elias
Boston University
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 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 NCT00007397, which also lists 3 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; AzTrials last refreshed its copy on 28 Oct 2026.