Cardiovascular DiseasesNCT00049920
The ARIC MRI Study
An observational study of Cardiovascular Diseases and Cerebrovascular Disorders, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in Communities (ARIC) magnetic resonance imaging subcohort. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Disorders, Cerebrovascular Accident
- How many people
- 1,134 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Sep 2008
- 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
Study population: Participants in the ARIC Neurocognitive Longitudinal Study were recruited for a follow-up brain MR scan and cognitive testing from the subset of the (parent) ARIC cohort that had an initial MR scan at the third (Visit 3) ARIC examination. Participants included black and white men and women.
Participated in the baseline ARIC MRI study.
About this study
Official title: The ARIC Neurocognitive Longitudinal Study
To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in Communities (ARIC) magnetic resonance imaging subcohort.
Read the detailed description
BACKGROUND:
Although the clinical manifestations of cerebrovascular disease (CVD) typically appear acutely, the deleterious effects of CVD on brain structure and function likely begin in a presymptomatic fashion at a younger age than clinical strokes. In an effort to characterize the prevalence, risk factors, and cognitive correlates of subclinical CVD, the Atherosclerosis Risk in Communities (ARIC) Study funded by the National Heart, Lung, and Blood Institute performed cerebral magnetic resonance imaging (MRI) and cognitive assessments on a large, bi-racial sample of middle-aged and young-elderly adults. Results from the ARIC MRI baseline study revealed a remarkably high prevalence of subclinical CVD including silent cerebral infarctions, white matter hyperintensities, and brain atrophy. Moreover, these subclinical abnormalities were found to be associated with reduced cognitive functioning and with clinical CVD outcomes such as incident stroke. Surprisingly little is known about risk factors related to the incidence or progression of subclinical CVD or how progression of these markers may relate to clinical outcomes such as stroke or neurocognitive decline.
DESIGN NARRATIVE:
This is a follow-up study of the ARIC MRI cohort, with repeated semiquantitative MR imaging and cognitive assessments. The study will also take advantage of recent advances in MR imaging and obtain volumetric measurements of selected brain regions and expand upon the baseline cognitive assessment to further characterize neurocognitive functioning. The longitudinal design of the proposed study will fill salient gaps in current understanding of subclinical CVD. Moreover, conducting this study within ARIC takes advantage of ARIC's baseline MRI data, unique African American population, and extensive vascular risk factor data (including new genetic and biochemical factors as well as subclinical markers of both large and small vessel disease), making an efficient study to provide new insights into the incidence, progression, and outcomes associated with subclinical CVD.
- Medical subject headings
- Cardiovascular Diseases, Cerebrovascular Disorders, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2002 (estimated)
- Study startSep 2002
- Primary completionMay 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,134 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas H Mosley, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049920
- Sponsor's protocol ID
- 1194
- Other IDs
- R01HL070825
- Status last verified
- Oct 2008
- First submitted
- 14 Nov 2002
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Knopman DS, Mosley TH, Catellier DJ, Sharrett AR; Atherosclerosis Risk in Communities (ARIC) Study. Cardiovascular risk factors and cerebral atrophy in a middle-aged cohort. Neurology. 2005 Sep 27;65(6):876-81. doi: 10.1212/01.wnl.0000176074.09733.a8.
PubMed 16186527
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ARIC Neurocognitive Longitudinal Study
- ClinicalTrials.gov ID
- NCT00049920
- Acronym / sponsor ID
- 1194
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,134 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2002
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Nov 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 perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in Communities (ARIC) magnetic resonance imaging subcohort.
Detailed description
BACKGROUND:
Although the clinical manifestations of cerebrovascular disease (CVD) typically appear acutely, the deleterious effects of CVD on brain structure and function likely begin in a presymptomatic fashion at a younger age than clinical strokes. In an effort to characterize the prevalence, risk factors, and cognitive correlates of subclinical CVD, the Atherosclerosis Risk in Communities (ARIC) Study funded by the National Heart, Lung, and Blood Institute performed cerebral magnetic resonance imaging (MRI) and cognitive assessments on a large, bi-racial sample of middle-aged and young-elderly adults. Results from the ARIC MRI baseline study revealed a remarkably high prevalence of subclinical CVD including silent cerebral infarctions, white matter hyperintensities, and brain atrophy. Moreover, these subclinical abnormalities were found to be associated with reduced cognitive functioning and with clinical CVD outcomes such as incident stroke. Surprisingly little is known about risk factors related to the incidence or progression of subclinical CVD or how progression of these markers may relate to clinical outcomes such as stroke or neurocognitive decline.
DESIGN NARRATIVE:
This is a follow-up study of the ARIC MRI cohort, with repeated semiquantitative MR imaging and cognitive assessments. The study will also take advantage of recent advances in MR imaging and obtain volumetric measurements of selected brain regions and expand upon the baseline cognitive assessment to further characterize neurocognitive functioning. The longitudinal design of the proposed study will fill salient gaps in current understanding of subclinical CVD. Moreover, conducting this study within ARIC takes advantage of ARIC's baseline MRI data, unique African American population, and extensive vascular risk factor data (including new genetic and biochemical factors as well as subclinical markers of both large and small vessel disease), making an efficient study to provide new insights into the incidence, progression, and outcomes associated with subclinical CVD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in the ARIC Neurocognitive Longitudinal Study were recruited for a follow-up brain MR scan and cognitive testing from the subset of the (parent) ARIC cohort that had an initial MR scan at the third (Visit 3) ARIC examination. Participants included black and white men and women.
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 29 Jul 2016.
- Background: PubMed 16186527Knopman DS, Mosley TH, Catellier DJ, Sharrett AR; Atherosclerosis Risk in Communities (ARIC) Study. Cardiovascular risk factors and cerebral atrophy in a middle-aged cohort. Neurology. 2005 Sep 27;65(6):876-81. doi: 10.1212/01.wnl.0000176074.09733.a8.
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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.
Thomas H Mosley, PhD principal investigator
University of Mississippi Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cerebrovascular Disorders, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 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 NCT00049920, which also lists 1 linked publication.
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 29 Jul 2016.