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The ARIC MRI Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00049920
First Posted: November 15, 2002
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in Communities (ARIC) magnetic resonance imaging subcohort.

Condition
Cardiovascular Diseases Cerebrovascular Disorders Cerebrovascular Accident

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049920


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Thomas H Mosley, PhD University of Mississippi Medical Center
  More Information

Publications:
Responsible Party: Thomas H. Mosley/Principal Investigator, University of Mississippi Medical center
ClinicalTrials.gov Identifier: NCT00049920     History of Changes
Other Study ID Numbers: 1194
R01HL070825 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2002
First Posted: November 15, 2002
Last Update Posted: July 29, 2016
Last Verified: October 2008

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