NCT01273311

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
719

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2014

Completed
Last Updated

April 5, 2018

Status Verified

February 18, 2014

First QC Date

January 7, 2011

Last Update Submit

April 4, 2018

Conditions

Keywords

Brain AgingDiabetesAgingObesityCARDIA

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

    PMID: 12365955BACKGROUND
  • Friedman GD, Cutter GR, Donahue RP, Hughes GH, Hulley SB, Jacobs DR Jr, Liu K, Savage PJ. CARDIA: study design, recruitment, and some characteristics of the examined subjects. J Clin Epidemiol. 1988;41(11):1105-16. doi: 10.1016/0895-4356(88)90080-7.

    PMID: 3204420BACKGROUND
  • Mainous AG 3rd, Baker R, Koopman RJ, Saxena S, Diaz VA, Everett CJ, Majeed A. Impact of the population at risk of diabetes on projections of diabetes burden in the United States: an epidemic on the way. Diabetologia. 2007 May;50(5):934-40. doi: 10.1007/s00125-006-0528-5. Epub 2006 Nov 21.

    PMID: 17119914BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Lenore J Launer, Ph.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

December 22, 2010

Study Completion

February 18, 2014

Last Updated

April 5, 2018

Record last verified: 2014-02-18

Locations