AtherosclerosisMESA-EyeNCT00041444
Multi-Ethnic Study of Atherosclerosis (MESA) - Ancillary Eye Study
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Wisconsin, Madison.
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. Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Coronary Arteriosclerosis
- How many people
- 6,176 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Cerebrovascular Disorders, Heart Failure, Congestive
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Cerebrovascular Disorders, Heart Failure, Myocardial Infarction, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2002 (estimated)
- Study startJun 2002
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ronald Klein, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041444
- Sponsor's protocol ID
- 2001-409
- Other IDs
- R01HL069979, 1182
- Acronym
- MESA-Eye
- Status last verified
- Feb 2016
- First submitted
- 8 Jul 2002
- Last updated
- 8 Feb 2016
- Results posted
- No
Publications
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. doi: 10.1001/archopht.122.11.1642.
PubMed 15534124Fernandez 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/j.ophtha.2011.09.044. Epub 2011 Dec 23.
PubMed 22197438Adar 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-based multi-ethnic study of atherosclerosis (MESA). PLoS Med. 2010 Nov 30;7(11):e1000372. doi: 10.1371/journal.pmed.1000372.
PubMed 21152417Cheung 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. doi: 10.1161/HYPERTENSIONAHA.107.091926. Epub 2007 Aug 13.
PubMed 17698721Cheung 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. doi: 10.1002/ana.21236.
PubMed 17918248Klein 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):1010-1020.e1. doi: 10.1016/j.ajo.2013.06.004. Epub 2013 Aug 12.
PubMed 23938121Wong 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. doi: 10.1016/j.ajo.2005.08.063.
PubMed 16490489Klein 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.
PubMed 20385944Colagiuri 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: 10.2337/dc10-1206. Epub 2010 Oct 26.
PubMed 20978099Klein 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;115(10):1742-9. doi: 10.1016/j.ophtha.2008.03.021. Epub 2008 Jun 5.
PubMed 18538409Nguyen 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/dc09-0102. Epub 2009 Jun 23.
PubMed 19549733Kawasaki 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/j.ophtha.2010.08.040. Epub 2010 Dec 18.
PubMed 21168222Kreis 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):40-2. doi: 10.3132/dvdr.2009.008.
PubMed 19156628Anuradha 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: 10.1093/aje/kwq412. Epub 2011 Feb 7.
PubMed 21300854Greenstein 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 4.
PubMed 21820181
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Ethnic Study of Atherosclerosis-Eye Study
- ClinicalTrials.gov ID
- NCT00041444
- Acronym / sponsor ID
- MESA-Eye / 2001-409
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Cerebrovascular Disorders, Heart Failure, Congestive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,176 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 9 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Results publication: PubMed 15534124Klein 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. doi: 10.1001/archopht.122.11.1642.
- Results publication: PubMed 22197438Fernandez 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/j.ophtha.2011.09.044. Epub 2011 Dec 23.
- Results publication: PubMed 21152417Adar 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-based multi-ethnic study of atherosclerosis (MESA). PLoS Med. 2010 Nov 30;7(11):e1000372. doi: 10.1371/journal.pmed.1000372.
- Results publication: PubMed 17698721Cheung 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. doi: 10.1161/HYPERTENSIONAHA.107.091926. Epub 2007 Aug 13.
- Results publication: PubMed 17918248Cheung 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. doi: 10.1002/ana.21236.
- Results publication: PubMed 23938121Klein 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):1010-1020.e1. doi: 10.1016/j.ajo.2013.06.004. Epub 2013 Aug 12.
- Results publication: PubMed 16490489Wong 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. doi: 10.1016/j.ajo.2005.08.063.
- Results publication: PubMed 20385944Klein 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.
- Results publication: PubMed 20978099Colagiuri 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: 10.2337/dc10-1206. Epub 2010 Oct 26.
- Results publication: PubMed 18538409Klein 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;115(10):1742-9. doi: 10.1016/j.ophtha.2008.03.021. Epub 2008 Jun 5.
- Results publication: PubMed 19549733Nguyen 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/dc09-0102. Epub 2009 Jun 23.
- Results publication: PubMed 21168222Kawasaki 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/j.ophtha.2010.08.040. Epub 2010 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Klein, MD, MPH principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041444, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.