Cardiovascular Diseases And Disorders |
Cardiovascular Diseases |
Clinical Trial: Multi-Ethnic Study of Atherosclerosis (MESA) - Ancillary Eye Study
This study is no longer recruiting patients.
Purpose
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.
| Condition |
|---|
| Atherosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Cerebrovascular Disorders Heart Failure, Congestive Myocardial Infarction Heart Diseases Diabetes Mellitus, non-insulin dependent Hypertension Diabetic Retinopathy Macular Degeneration Diabetes Mellitus |
MedlinePlus related topics: Coronary Disease; Diabetes; Diabetic Eye Problems; Heart Attack; Heart Diseases; Heart Diseases--Prevention; Heart Failure; High Blood Pressure; Macular Degeneration; Stroke; Vascular Diseases
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population
Study start: June 2002; Study completion: May 2006
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.
Eligibility
Ages Eligible for Study: 45 Years - 84 Years, Genders Eligible for Study: Both
Criteria
Location Information
Ronald Klein, University of Wisconsin
More Information
Publications
Klein R, Meuer SM, Moss SE, Klein BE, Neider MW, Reinke J. Detection of age-related macular degeneration using a nonmydriatic digital camera and a standard film fundus camera. Arch Ophthalmol. 2004 Nov;122(11):1642-6.
Record last reviewed: February 2005
Last Updated: February 15, 2005
Record first received: July 8, 2002
ClinicalTrials.gov Identifier: NCT00041444
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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