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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00041444
First received: July 8, 2002
Last updated: March 12, 2014
Last verified: March 2014
  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

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Study Start Date: June 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00041444

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Investigator: Ronald Klein University of Wisconsin, Madison
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00041444     History of Changes
Other Study ID Numbers: 1182, R01HL069979
Study First Received: July 8, 2002
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Cerebrovascular Disorders
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Retinopathy
Heart Diseases
Heart Failure
Hypertension
Infarction
Macular Degeneration
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Brain Diseases
Central Nervous System Diseases
Diabetes Complications
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Ischemia
Metabolic Diseases
Necrosis
Nervous System Diseases
Pathologic Processes
Retinal Degeneration

ClinicalTrials.gov processed this record on October 30, 2014