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

Hypertension Clinical Trial

— MESA-Eye  

Official title:

Multi-Ethnic Study of Atherosclerosis-Eye Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041444
• Other study ID #: 2001-409
• Secondary ID: R01HL0699791182
• Status: Completed
• Phase: N/A
• First received: July 8, 2002
• Last updated: February 5, 2016
• Start date: June 2002
• Est. completion date: November 2006

Study information

• Verified date: February 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6176
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 84 Years
• Eligibility: No eligibility criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Cardiovascular Diseases
• Cerebrovascular Disorders
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Non-insulin Dependent
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Heart Diseases
• Heart Failure
• Heart Failure, Congestive
• Hypertension
• Macular Degeneration
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (30)

Adar SD, Klein R, Klein BE, Szpiro AA, Cotch MF, Wong TY, O'Neill MS, Shrager S, Barr RG, Siscovick DS, Daviglus ML, Sampson PD, Kaufman JD. Air Pollution and the microvasculature: a cross-sectional assessment of in vivo retinal images in the population-b — View Citation

Anuradha S, Healy GN, Dunstan DW, Klein R, Klein BE, Cotch MF, Wong TY, Owen N. Physical activity, television viewing time, and retinal microvascular caliber: the multi-ethnic study of atherosclerosis. Am J Epidemiol. 2011 Mar 1;173(5):518-25. doi: 10.109 — View Citation

Cheung N, Bluemke DA, Klein R, Sharrett AR, Islam FM, Cotch MF, Klein BE, Criqui MH, Wong TY. Retinal arteriolar narrowing and left ventricular remodeling: the multi-ethnic study of atherosclerosis. J Am Coll Cardiol. 2007 Jul 3;50(1):48-55. Epub 2007 Jun — View Citation

Cheung N, Islam FM, Jacobs DR Jr, Sharrett AR, Klein R, Polak JF, Cotch MF, Klein BE, Ouyang P, Wong TY. Arterial compliance and retinal vascular caliber in cerebrovascular disease. Ann Neurol. 2007 Dec;62(6):618-24. — View Citation

Cheung N, Klein R, Wang JJ, Cotch MF, Islam AF, Klein BE, Cushman M, Wong TY. Traditional and novel cardiovascular risk factors for retinal vein occlusion: the multiethnic study of atherosclerosis. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4297-302. doi: — View Citation

Cheung N, Sharrett AR, Klein R, Criqui MH, Islam FM, Macura KJ, Cotch MF, Klein BE, Wong TY. Aortic distensibility and retinal arteriolar narrowing: the multi-ethnic study of atherosclerosis. Hypertension. 2007 Oct;50(4):617-22. Epub 2007 Aug 13. — View Citation

Colagiuri S, Lee CM, Wong TY, Balkau B, Shaw JE, Borch-Johnsen K; DETECT-2 Collaboration Writing Group. Glycemic thresholds for diabetes-specific retinopathy: implications for diagnostic criteria for diabetes. Diabetes Care. 2011 Jan;34(1):145-50. doi: 10 — View Citation

Fernandez AB, Wong TY, Klein R, Collins D, Burke G, Cotch MF, Klein B, Sadeghi MM, Chen J. Age-related macular degeneration and incident cardiovascular disease: the Multi-Ethnic Study of Atherosclerosis. Ophthalmology. 2012 Apr;119(4):765-70. doi: 10.1016 — View Citation

Fisher DE, Shrager S, Shea SJ, Burke GL, Klein R, Wong TY, Klein BE, Cotch MF. Visual Impairment in White, Chinese, Black, and Hispanic Participants from the Multi-Ethnic Study of Atherosclerosis Cohort. Ophthalmic Epidemiol. 2015;22(5):321-32. doi: 10.31 — View Citation

Greenstein MB, Myers CE, Meuer SM, Klein BE, Cotch MF, Wong TY, Klein R. Prevalence and characteristics of choroidal nevi: the multi-ethnic study of atherosclerosis. Ophthalmology. 2011 Dec;118(12):2468-73. doi: 10.1016/j.ophtha.2011.05.007. Epub 2011 Aug — View Citation

Kawasaki R, Cheung N, Islam FM, Klein R, Klein BE, Cotch MF, Sharrett AR, O'Leary D, Wong TY; Multi-Ethnic Study of Atherosclerosis. Is diabetic retinopathy related to subclinical cardiovascular disease? Ophthalmology. 2011 May;118(5):860-5. doi: 10.1016/ — View Citation

Kawasaki R, Cheung N, Wang JJ, Klein R, Klein BE, Cotch MF, Sharrett AR, Shea S, Islam FA, Wong TY. Retinal vessel diameters and risk of hypertension: the Multiethnic Study of Atherosclerosis. J Hypertens. 2009 Dec;27(12):2386-93. doi: 10.1097/HJH.0b013e3 — View Citation

Kawasaki R, Xie J, Cheung N, Lamoureux E, Klein R, Klein BE, Cotch MF, Sharrett AR, Shea S, Wong TY; MESA. Retinal microvascular signs and risk of stroke: the Multi-Ethnic Study of Atherosclerosis (MESA). Stroke. 2012 Dec;43(12):3245-51. doi: 10.1161/STRO — View Citation

Klein R, Klein BE, Knudtson MD, Cotch MF, Wong TY, Liu K, Burke GL, Saad MF, Jacobs DR Jr, Sharrett AR. Subclinical atherosclerotic cardiovascular disease and early age-related macular degeneration in a multiracial cohort: the Multiethnic Study of Atheros — View Citation

Klein R, Klein BE, Knudtson MD, Wong TY, Cotch MF, Liu K, Burke G, Saad MF, Jacobs DR Jr. Prevalence of age-related macular degeneration in 4 racial/ethnic groups in the multi-ethnic study of atherosclerosis. Ophthalmology. 2006 Mar;113(3):373-80. — View Citation

Klein R, Knudtson MD, Klein BE, Wong TY, Cotch MF, Barr G. Emphysema, airflow limitation, and early age-related macular degeneration. Arch Ophthalmol. 2010 Apr;128(4):472-7. doi: 10.1001/archophthalmol.2010.25. — View Citation

Klein R, Knudtson MD, Klein BE, Wong TY, Cotch MF, Liu K, Cheng CY, Burke GL, Saad MF, Jacobs DR Jr, Sharrett AR. Inflammation, complement factor h, and age-related macular degeneration: the Multi-ethnic Study of Atherosclerosis. Ophthalmology. 2008 Oct;1 — View Citation

Klein R, Li X, Kuo JZ, Klein BE, Cotch MF, Wong TY, Taylor KD, Rotter JI. Associations of candidate genes to age-related macular degeneration among racial/ethnic groups in the multi-ethnic study of atherosclerosis. Am J Ophthalmol. 2013 Nov;156(5):1010-10 — View Citation

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. — View Citation

Kreis AJ, Wong TY, Islam FM, Klein R, Klein BE, Cotch MF, Jenkins AJ, Shea S, Wang JJ. Is nuclear magnetic resonance lipoprotein subclass related to diabetic retinopathy? The multi-ethnic study of atherosclerosis (MESA). Diab Vasc Dis Res. 2009 Jan;6(1):4 — View Citation

Ng CH, Cheung N, Wang JJ, Islam AF, Kawasaki R, Meuer SM, Cotch MF, Klein BE, Klein R, Wong TY. Prevalence and risk factors for epiretinal membranes in a multi-ethnic United States population. Ophthalmology. 2011 Apr;118(4):694-9. doi: 10.1016/j.ophtha.20 — View Citation

Nguyen TT, Alibrahim E, Islam FM, Klein R, Klein BE, Cotch MF, Shea S, Wong TY. Inflammatory, hemostatic, and other novel biomarkers for diabetic retinopathy: the multi-ethnic study of atherosclerosis. Diabetes Care. 2009 Sep;32(9):1704-9. doi: 10.2337/dc — View Citation

Nguyen TT, Islam FM, Farouque HM, Klein R, Klein BE, Cotch MF, Herrington DM, Wong TY. Retinal vascular caliber and brachial flow-mediated dilation: the Multi-Ethnic Study of Atherosclerosis. Stroke. 2010 Jul;41(7):1343-8. doi: 10.1161/STROKEAHA.110.58101 — View Citation

Nguyen TT, Wang JJ, Sharrett AR, Islam FM, Klein R, Klein BE, Cotch MF, Wong TY. Relationship of retinal vascular caliber with diabetes and retinopathy: the Multi-Ethnic Study of Atherosclerosis (MESA). Diabetes Care. 2008 Mar;31(3):544-9. Epub 2007 Dec 1 — View Citation

Ojaimi E, Nguyen TT, Klein R, Islam FM, Cotch MF, Klein BE, Wang JJ, Wong TY. Retinopathy signs in people without diabetes: the multi-ethnic study of atherosclerosis. Ophthalmology. 2011 Apr;118(4):656-62. doi: 10.1016/j.ophtha.2010.08.007. Epub 2010 Nov — View Citation

Wong TY, Cheung N, Islam FM, Klein R, Criqui MH, Cotch MF, Carr JJ, Klein BE, Sharrett AR. Relation of retinopathy to coronary artery calcification: the multi-ethnic study of atherosclerosis. Am J Epidemiol. 2008 Jan 1;167(1):51-8. Epub 2007 Sep 24. — View Citation

Wong TY, Islam FM, Klein R, Klein BE, Cotch MF, Castro C, Sharrett AR, Shahar E. Retinal vascular caliber, cardiovascular risk factors, and inflammation: the multi-ethnic study of atherosclerosis (MESA). Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2341-50. — View Citation

Wong TY, Klein R, Islam FM, Cotch MF, Folsom AR, Klein BE, Sharrett AR, Shea S. Diabetic retinopathy in a multi-ethnic cohort in the United States. Am J Ophthalmol. 2006 Mar;141(3):446-455. — View Citation

Wong TY, Liew G, Tapp RJ, Schmidt MI, Wang JJ, Mitchell P, Klein R, Klein BE, Zimmet P, Shaw J. Relation between fasting glucose and retinopathy for diagnosis of diabetes: three population-based cross-sectional studies. Lancet. 2008 Mar 1;371(9614):736-43 — View Citation

Yau JW, Xie J, Lamoureux E, Klein R, Klein BE, Cotch MF, Bertoni AG, Shea S, Wong TY. Retinal microvascular calibre and risk of incident diabetes: the multi-ethnic study of atherosclerosis. Diabetes Res Clin Pract. 2012 Feb;95(2):265-74. doi: 10.1016/j.di — View Citation

* Note: There are 30 references in all — Click here to view all references