NCT00063440

Brief Summary

To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

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

June 1, 2003

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

4.9 years

First QC Date

June 26, 2003

Last Update Submit

February 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Common carotid artery intima-media thickness

    randomly selected at 2 years or 4 years in 1/2 of the cohort

Secondary Outcomes (1)

  • Common carotid artery diameter

    randomly selected at 2 or 4 years for each 1/2 of the cohort

Eligibility Criteria

Age45 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants of the Multi-Ethnic Study of Atherosclerosis, a cross-sectional NIH population cohort originating from 6 regions in the United States

Members of MESA study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (5)

  • Polak JF, Herrington D, O'Leary DH. Associations of edge-detected and manual-traced common carotid artery intima-media thickness with incident peripheral artery disease: The Multi-Ethnic Study of Atherosclerosis. Vasc Med. 2019 Aug;24(4):306-312. doi: 10.1177/1358863X19835925. Epub 2019 Apr 26.

  • Polak JF, O'Leary DH. Edge-detected common carotid artery intima-media thickness and incident coronary heart disease in the multi-ethnic study of atherosclerosis. J Am Heart Assoc. 2015 Jun 15;4(6):e001492. doi: 10.1161/JAHA.114.001492.

  • Polak JF, Sacco RL, Post WS, Vaidya D, Arnan MK, O'Leary DH. Incident stroke is associated with common carotid artery diameter and not common carotid artery intima-media thickness. Stroke. 2014 May;45(5):1442-6. doi: 10.1161/STROKEAHA.114.004850. Epub 2014 Mar 18.

  • Polak JF, Johnson C, Harrington A, Wong Q, O'Leary DH, Burke G, Yanez ND. Changes in carotid intima-media thickness during the cardiac cycle: the multi-ethnic study of atherosclerosis. J Am Heart Assoc. 2012 Aug;1(4):e001420. doi: 10.1161/JAHA.112.001420. Epub 2012 Aug 24.

  • Polak JF, Wong Q, Johnson WC, Bluemke DA, Harrington A, O'Leary DH, Yanez ND. Associations of cardiovascular risk factors, carotid intima-media thickness and left ventricular mass with inter-adventitial diameters of the common carotid artery: the Multi-Ethnic Study of Atherosclerosis (MESA). Atherosclerosis. 2011 Oct;218(2):344-9. doi: 10.1016/j.atherosclerosis.2011.05.033. Epub 2011 Jun 14.

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesCarotid Artery DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCoronary DiseaseMyocardial Ischemia

Study Officials

  • Joseph F Polak, MD, MPH

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2003

First Posted

June 30, 2003

Study Start

June 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 8, 2013

Record last verified: 2013-02