Retinal Arteriolar Abnormalities and CV Mortality

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011167
• Other study ID #: 2000-112
• Secondary ID: R01HL066018960
• Status: Completed
• Phase: N/A
• First received: February 13, 2001
• Last updated: February 5, 2016
• Start date: March 2001
• Est. completion date: February 2003

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 determine whether retinal arteriolar changes (generalized narrowing, focal narrowing and arterio-venous nicking) and retinopathy were associated with 10-year stroke-and ischemic heart disease-related mortality.

Description:

BACKGROUND:

Blood vessels in the retina of the eye provide a valuable window for evaluating quantitatively small vessel arteriosclerosis (arteriolar narrowing, arterio-venous nicking and arterio-to-venule ratio (AVR)). Previous studies have suggested that these optic fundi vascular parameters may be useful measures of generalized vascular disease and may have important prognostic implications. This study addressed this issue in a quantitative way using an established cohort with previously acquired fundic photographs. The study addressed an important public health problem with findings that may identify at-risk patients who would benefit from earlier intervention.

The established cohort was from the Beaver Dam Eye Study cohort, a well-characterized population of predominantly white persons aged 43-86 years at the baseline in 1988-1990. The cohort was originally evaluated in 1988-1990 with routine clinical and laboratory evaluation plus high-quality optic fundi photos. The population had been followed over a 10-year period with identified deaths from ischemic heart disease or stroke.

DESIGN NARRATIVE:

This was a population-based case-cohort study to determine whether retinal arteriolar changes (generalized narrowing, focal narrowing and arterio-venous nicking) and retinopathy were associated with 10-year stroke-and ischemic heart disease-related mortality. The study population was selected from participants of the Beaver Dam Eye Study, a well-characterized population of predominantly white persons aged 43-86 years at the baseline examination in 1988-90. Cases were defined as participants who had died from either stroke or ischemic heart disease since the baseline examination. Three participants per case were selected from the cohort at baseline as controls, matched on gender and 5-year age intervals to cases. Focal arteriolar narrowing, arteriovenous nicking and retinopathy were graded to baseline using a standardized photographic grading protocol. To evaluate generalized arteriolar narrowing, a method modified from the Atherosclerosis Risk in Communities study was used. Retinal photographs were digitized and processed using a high-resolution scanner. Retinal arteriole and venule widths were then measured with the help of a computer program based on pixel density contrast between the vessel and the background retina. Finally, the average width of the arterioles was summarized as a retinal arteriole to venule ratio (AVR). Standard case-control methodology were applied to calculate the relative odds of association between generalized retinal arteriolar narrowing (using different categories of AVR) and other changes with stroke-and ischemic heart disease-related mortality. Logistic regression models controlling for potential confounders (e.g., blood pressure, serum lipid levels) were employed to evaluate the independent association between retinal arteriolar characteristics and stroke- and ischemic heart disease mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1380
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 43 Years to 86 Years

Eligibility

• Participated in the baseline examination of the Beaver Dam Eye Study in 1988-1990

• Had gradable fundus photographs taken at the baseline examination of the Beaver Dam Eye Study in 1988-1990

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disorders
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases

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 (8)

Knudtson MD, Klein BE, Klein R, Wong TY, Hubbard LD, Lee KE, Meuer SM, Bulla CP. Variation associated with measurement of retinal vessel diameters at different points in the pulse cycle. Br J Ophthalmol. 2004 Jan;88(1):57-61. — View Citation

Knudtson MD, Lee KE, Hubbard LD, Wong TY, Klein R, Klein BE. Revised formulas for summarizing retinal vessel diameters. Curr Eye Res. 2003 Sep;27(3):143-9. — View Citation

Wong TY, Klein R, Klein BE, Meuer SM, Hubbard LD. Retinal vessel diameters and their associations with age and blood pressure. Invest Ophthalmol Vis Sci. 2003 Nov;44(11):4644-50. — View Citation

Wong TY, Klein R, Nieto FJ, Klein BE, Sharrett AR, Meuer SM, Hubbard LD, Tielsch JM. Retinal microvascular abnormalities and 10-year cardiovascular mortality: a population-based case-control study. Ophthalmology. 2003 May;110(5):933-40. — View Citation

Wong TY, Knudtson MD, Klein R, Klein BE, Hubbard LD. A prospective cohort study of retinal arteriolar narrowing and mortality. Am J Epidemiol. 2004 May 1;159(9):819-25. — View Citation

Wong TY, Knudtson MD, Klein R, Klein BE, Meuer SM, Hubbard LD. Computer-assisted measurement of retinal vessel diameters in the Beaver Dam Eye Study: methodology, correlation between eyes, and effect of refractive errors. Ophthalmology. 2004 Jun;111(6):1183-90. — View Citation

Wong TY, Shankar A, Klein R, Klein BE, Hubbard LD. Prospective cohort study of retinal vessel diameters and risk of hypertension. BMJ. 2004 Jul 10;329(7457):79. Epub 2004 Jun 2. Erratum in: BMJ. 2004 Aug 14;329(7462):384. — View Citation

Wong TY, Shankar A, Klein R, Klein BE, Hubbard LD. Retinal arteriolar narrowing, hypertension, and subsequent risk of diabetes mellitus. Arch Intern Med. 2005 May 9;165(9):1060-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death due to stroke or ischemic heart disease			No