Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Retinal Arteriolar Abnormalities and CV Mortality

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00011167
First received: February 13, 2001
Last updated: February 5, 2016
Last verified: February 2016

February 13, 2001
February 5, 2016
March 2001
February 2003   (final data collection date for primary outcome measure)
Death due to stroke or ischemic heart disease [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00011167 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Retinal Arteriolar Abnormalities and CV Mortality
Not Provided
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
The Beaver Dam Eye Study cohort was first identified by a private census of the city of Beaver Dam, Wisconsin from September 15, 1987 to May 4, 1988, was examined from 1988-90 (baseline examination), and re-examined in 1993-95 and 1998-2000. The baseline examination formed the population for both cases and controls. Cases were defined as study participants who had died since the baseline examination from stroke or ischemic heart disease. Three participants per case were selected from the entire cohort at baseline as controls, age and sex matched to cases, irrespective of vital status. No participants were recruited specifically for this study.
  • Cardiovascular Diseases
  • Heart Diseases
  • Cerebrovascular Disorders
  • Coronary Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1380
February 2003
February 2003   (final data collection date for primary outcome measure)
  • 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
Both
43 Years to 86 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00011167
2000-112, R01HL066018, 960
No
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Ronald Klein University of Wisconsin, Madison
University of Wisconsin, Madison
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP