Multi-Ethnic Study of Atherosclerosis (MESA) - Ancillary Eye Study (MESA-Eye)
|ClinicalTrials.gov Identifier: NCT00041444|
Recruitment Status : Completed
First Posted : July 9, 2002
Last Update Posted : February 8, 2016
|Condition or disease|
|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|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||6176 participants|
|Official Title:||Multi-Ethnic Study of Atherosclerosis-Eye Study|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041444
|Principal Investigator:||Ronald Klein, MD, MPH||University of Wisconsin, Madison|