Clinical trial NCT00063440: Epidemiology of Carotid IMT Progression in MESA - Ancillary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Carotid Artery Diseases
Coronary Arteriosclerosis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2003-06-30
Enrollment: 5610
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Members of MESA study

Primary outcomes:
measure: Common carotid artery intima-media thickness
timeFrame: randomly selected at 2 years or 4 years in 1/2 of the cohort
Secondary outcomes:
measure: Common carotid artery diameter
timeFrame: randomly selected at 2 or 4 years for each 1/2 of the cohort
Other outcomes:
Locations:
Study officials:
affiliation: Tufts Medical Center
name: Joseph F Polak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.