CARDIA Brain MRI Substudy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT01273311
First received: January 7, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.

Condition
Brain Aging
Obesity
Diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Contribution of Diabetes and Its Causes to Signs of Brain Aging in a Young-to-Middle Age Cohort

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 725
Study Start Date: December 2010
Estimated Study Completion Date: February 2014
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).

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273311

Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Lenore J Launer, Ph.D. National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01273311     History of Changes
Other Study ID Numbers: 999911071, 11-AG-N071
Study First Received: January 7, 2011
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Brain Aging
Diabetes
Aging
Obesity
CARDIA

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 02, 2014