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The ARIC MRI Study
This study has been completed.
First Received: November 14, 2002   Last Updated: October 7, 2008   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00049920
  Purpose

To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in Communities (ARIC) magnetic resonance imaging subcohort.


Condition Phase
Cardiovascular Diseases
Cerebrovascular Disorders
Cerebrovascular Accident
N/A

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: The ARIC Neurocognitive Longitudinal Study

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Plasma and DNA


Enrollment: 1134
Study Start Date: September 2002
Study Completion Date: September 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Participated in the baseline ARIC MRI study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049920

Sponsors and Collaborators
Investigators
Principal Investigator: Thomas H Mosley, PhD University of Mississippi Medical Center
  More Information

Publications:
Responsible Party: University of Mississippi Medical center ( Thomas H. Mosley/Principal Investigator )
Study ID Numbers: 1194
Study First Received: November 14, 2002
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00049920     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009