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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041444
First Posted: July 9, 2002
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Ethnic Study of Atherosclerosis-Eye Study

Resource links provided by NLM:


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

Enrollment: 6176
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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041444


Sponsors and Collaborators
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ronald Klein, MD, MPH University of Wisconsin, Madison
  More Information

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00041444     History of Changes
Other Study ID Numbers: 2001-409
R01HL069979 ( U.S. NIH Grant/Contract )
1182 ( Other Identifier: Study Team )
First Submitted: July 8, 2002
First Posted: July 9, 2002
Last Update Posted: February 8, 2016
Last Verified: February 2016

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