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Multi-Ethnic Study of Atherosclerosis (MESA) - Ancillary Eye Study (MESA-Eye)

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Coronary Arteriosclerosis
Diabetes Mellitus, Non-insulin Dependent
Diabetes Mellitus
Myocardial Infarction
Cardiovascular Diseases
Cerebrovascular Disorders
Atherosclerosis
Hypertension
Macular Degeneration
Heart Failure, Congestive
Heart Diseases
Coronary Disease
Diabetic Retinopathy

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00041444
R01HL069979 (U.S. NIH Grant/Contract)
1182 (Other Identifier)
2001-409

Details and patient eligibility

About

To evaluate the relation of retinal microvascular characteristics to subclinical cardiovascular disease, clinical disease, and their risk factors in the Multi-Ethnic Study of Atherosclerosis (MESA) cohort.

Full description

BACKGROUND:

The study further expands and enlarges the findings of the NHLBI-supported Atherosclerosis Risk in Communities (ARIC) study on the relationship of retinal microvascular disease to the presence of subclinical and clinical cardiovascular disease among Multi-Ethnic Study of Atherosclerosis (MESA) participants. ARIC data showed that retinal microvascular changes were associated with the following findings: markers of persistent hypertensive damage, markers of inflammation and endothelial dysfunction, magnetic resonance imaging (MRI)-detected cerebral infarct independent of hypertension, predictive of 3-year incident stroke independent of hypertension, and predictive of 3-year incident coronary heart disease in women but not men.

DESIGN NARRATIVE:

The MESA-EYE study is a separate add-on to the Multi-Ethnic Study of Atherosclerosis, a six regional center 10 year program begun in July 2000. The overall goals of the parent study are the identification of risk factors for subclinical cardiovascular disease, for progression of subclinical disease, and for transition of subclinical to clinical cardiovascular disease. The eye component will tie in with Exam 2 of the main study which begins August 2002 and runs through January 2004. Retinal photography to document microvascular changes will be performed on the approximately 6,500 MESA participants at Exam 2. Retinal photography will follow a standardized written protocol similar to that used in ARIC. Focal arterial narrowing and AV nicking will be classified as definite, questionable, or none. Data handling will be based on protocols previously used in several other NIH sponsored clinical trials where eye retinal studies were performed.

The six specific aims of the study are to: (1) determine the relationship of retinal microvascular characteristics to measures of subclinical CVD through (a) magnetic resonance imaging of left ventricular function (b) brachial artery ultrasound for flow mediated endothelial vasodilatation (c) radial artery tonometry measurement of peripheral artery function (d) magnetic resonance imaging for myocardial perfusion; (2) determine relationship of retinal microvascular characteristics to clinical CVD, specifically: (a) coronary heart disease (b) congestive cardiac failure (c) stroke; (3) determine relationship of retinal microvascular characteristics to CVD risk factors, specifically:(a) development of type 2 diabetes (b) development of hypertension (c) markers of: (I) inflammation (II) hemostasis (III) fibrinolysis; (4) determine the relation of retinal microvascular changes to structural and functional disorders of the brain; (5) describe the prevalence of retinal microvascular abnormalities in different racial/ethnic groups; (6) describe the prevalence and risk factors of (a) diabetic retinopathy (b) age-related maculopathy.

Enrollment

6,176 patients

Sex

All

Ages

45 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

No eligibility criteria

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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