CARDIA Brain MRI Substudy

April 4, 2018 updated by: National Institute on Aging (NIA)

Contribution of Diabetes and Its Causes to Signs of Brain Aging in a Young-to-Middle Age Cohort

Background:

- The Coronary Artery Risk Development in Young Adults (CARDIA) study is an investigation of cardiovascular risk factors among African-American and white young adults between 18 and 30 years of age, first recruited in 1985 86 from Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA. The study has examined a wide variety of risk factors, including insulin resistance, obesity, and diabetes. Based on 20 years of followup, the data provide evidence of an increase in the prevalence of many cardiovascular risk factors, as well as other factors that may lead to brain disease. To further evaluate these changes, the CARDIA Year 25 Exam will include a brain imaging component to study brain structure and function in a subset of CARDIA participants.

Objectives:

- To conduct brain magnetic resonance imaging as part of a 25-year followup study on participants in the original CARDIA study of heart disease risk factors in young adults.

Eligibility:

- Existing CARDIA study participants in the Minneapolis, MN, and Oakland, CA regions.

Design:

  • Participants will be screened with a full medical history and physical examination. - Participants will have an MRI scan at the 25-year followup examination for the CARDIA study.
  • No additional testing or treatment will be required for this protocol.

Study Overview

Status

Completed

Conditions

Detailed Description

The Coronary Artery Risk Development in Young Adults (CARDIA) Study is a prospective, epidemiologic investigation of the determinants and evolution of cardiovascular risk factors among 5,115 African American and white young to middle age adults 18-30 years of age at baseline in 1985-86. Participants were recruited from the populations of four geographic locations (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA). The study population was approximately balanced according to sex (54% women), ethnicity (52% African American), and education (40% with less than equal to 12 years of education) at each center (Friedman). After the 1984 baseline, additional examinations were undertaken at years 2 (1987-88), 5 (1990-91), 7 (1992-93), 10 (1995-96), 15 (2000-01) and 20 (2005-06). To date, 72% of the total baseline cohort is still active in the study.

Based on 20 years of follow-up, the longitudinal data on this cohort provide clear evidence of an increase in the prevalence of many cardiovascular risk factors, including obesity and diabetes. Therefore, the study presents an ideal and unique opportunity to study change in cardiovascular risk factors beginning at an age we hypothesize may be critical in determining future trajectories of brain disease. Furthermore, the trends in CV-RF reflect general trends in the US population. Thus, CARDIA participants are ideal to study now because the cohort reflects the characteristics of the next generation of older persons.

This is an ancillary study of MRI-evident neurodegenerative and vascular brain changes in a subset of 719 CARDIA participants who participate in the Year 25 Exam. Specifically, we will study the relations of timing length of exposure and levels of cardiovascular risk factors to presence of sub-clinical brain lesions and cognitive impairments. Participants were recruited from the CARDIA field sites at Birmingham, AL (PI: Cora E. Lewis, MD, MSPH- University of Lalbama, Nirmingham), Minneapolis, MN (PI: Pamela Schreiner, PhD, MS- University of Minnesota) and Oakland, CA (PI: Steve Sidney, MD, mPH- Kaiser Permanente).

Study Type

Observational

Enrollment (Actual)

719

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • National Institute of Aging, Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

A qualified participant from the CARDIA trial that does not have any of the below MRI contraindications.

EXCLUSION CRITERIA:

Participants with a known contraindication to an MRI examination will be excluded from the study (severe claustrophobia, pacemaker, defibrillator, neuro-stimulator, ferro-magnetic aneurysm clip or an unknown, 3T MR incompatible metal implant of any kind or any foreign metal objects in the body such as bullets, shrapnel, metal slivers, etc).

Any female participant of childbearing age who has not tested negative on a pregnancy test prior to the scheduled MRI exam will also be excluded from participation in the Brain MRI Substudy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Lenore J Launer, Ph.D., National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 22, 2010

Study Completion

February 18, 2014

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

February 18, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999911071
  • 11-AG-N071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe