Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041444
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2002-07-08
Brief Title:
Multi-Ethnic Study of Atherosclerosis MESA - Ancillary Eye Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Multi-Ethnic Study of Atherosclerosis-Eye Study
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MESA-Eye
Brief 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
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 6500 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 specificallya 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 racialethnic groups 6 describe the prevalence and risk factors of a diabetic retinopathy b age-related maculopathy
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 6500 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 specificallya 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 racialethnic groups 6 describe the prevalence and risk factors of a diabetic retinopathy b age-related maculopathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1182 | OTHER | Study Team | httpsreporternihgovquickSearchR01HL069979 |
| R01HL069979 | NIH | None | None |