Hypertension Clinical Trial
Official title:
Multi-Ethnic Study of Atherosclerosis-Eye Study
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.
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.
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