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CompletedNCT00063440Updated Feb 8, 2013

Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

An observational study in Atherosclerosis, Cardiovascular Diseases and Heart Diseases, sponsored by Tufts Medical Center. Completed. Open to participants aged 45 Years to 84 Years. Per ClinicalTrials.gov, last updated 2013-02-08.

Sponsored by Tufts Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,610
Ages
45 Years to 84 Years
Sex
All
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Study 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.

Read the detailed description

BACKGROUND:

Cardiovascular disease remains the leading cause of death in the United States and one of the leading causes of morbidity. New technology recently has allowed the non-invasive investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the clinical implications and significance of this new technology have not yet been fully examined nor has the interrelationship between these various measurements of clinical and sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in several ethnic groups.

DESIGN NARRATIVE:

A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the scheduled follow-up visits in MESA subjects in order to study the relationship between carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies will be conducted on how these two non-invasive markers of atherosclerosis relate to cardiovascular disease risk factors and clinical events.The study will utilize the MESA cohort involving 6500 subjects who will have baseline and four follow-up examinations. coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC determinations also scheduled at follow-up. IMT determinations will be added in conjunction with the CAC studies in the second and third exams and detailed analyses will be carried out on these two measures of atherosclerotic burden that may reflect different biologic processes.

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Conditions studied

  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Carotid Artery Diseases
  • Coronary Arteriosclerosis
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In context

Carotid Artery Diseases

248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.

This study's enrollment of 5,610 is above the median of 224 across 108 observational studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Eligibility criteria

Members of MESA study

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,610 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Common carotid artery intima-media thickness

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

Secondary outcomes

  1. Common carotid artery diameter

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 31023166 ↗
  • 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. PubMed 26077584 ↗
  • 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. PubMed 24643408 ↗
  • 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. PubMed 23130162 ↗
  • 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. PubMed 21726862 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00063440
Lead sponsor
Tufts Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Jun 30, 2003
Start date
Jun 2003
Primary completion
May 2008
Completion
May 2008
Last update
Feb 8, 2013

Study contacts

Joseph F Polak, MD, MPH
principal investigator · Tufts Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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