Retinal Vessel Measurements as Clinically Useful Predictors in Veterans

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01772173
First received: January 16, 2013
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

Diabetic complications are an important source of blindness and mortality among veterans. Their occurrence is unpredictable because of the highly variable effect of factors such as weight, diet and exercise. Improved prediction of diabetes complications has the potential to improve the care for veterans with diabetes, especially if this can be done without any extra effort for the veterans or their caretakers. All veterans with diabetes in VHA are required to undergo annual retinal photography to screen for current diabetic retinopathy. We have recently developed an automated, precise, fast, novel tool for measuring retinal vessels in these images. Manual measurement of retinal vessels has shown that these can predict future -not current- development of hypertension and also diabetic retinopathy. If we can confirm that our tool can flag those veterans at increased risk for developing these diabetes complications, this will allow earlier intervention and prevention. Because the tool only uses the images that are being taken anyway, there is no extra effort for either the veteran or VA staff.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retinal Vessel Measurements as Clinically Useful Predictors in Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Area under the Curve of algorithm [ Time Frame: 2/1/2016 ] [ Designated as safety issue: No ]
    AUC of automatically derived retinal vessel parameters (arterial and retinal vessel width and branch relationships) as an early biomarker for future development of hypertension no less than 2 years later, with normal current normal blood pressure.


Biospecimen Retention:   None Retained

Retinal images - vessel parameters


Estimated Enrollment: 4500
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypertension prediction
500 veterans with diabetes, all of whom did not have hypertension at the time of imaging
Retinopathy prediction
retinal images from a population of 4000 veterans with diabetes, currently without DR, ~10% of who developed retinopathy no less than two years later while the remainder did not.

Detailed Description:

Background: We hypothesize that retinal vessel derived biomarkers, obtained using our automated, precise, fast, novel tool for measuring retinal vessels in retinal images can identify veterans at increased risk for diabetic retinopathy and hypertension, before any overt signs of retinopathy or increased blood pressure have become apparent. Population studies have shown that changes in arterial and venous diameter are associated with future development of these complications.

Purpose: Determine the potential utility of retinal vessel derived biomarkers, from color fundus photographs, as a non-invasive independent risk factor for diabetic retinopathy (DR) and hypertension in veterans with diabetes.

Methods: Aim 1. We will evaluate automatically derived retinal vessel parameters (arterial and retinal vessel width and branch relationships) as an early biomarker for future development of hypertension no less than 2 years later, with normal current normal blood pressure. We will compare this biomarker in retinal images from 500 veterans with diabetes, all of whom did not have hypertension at the time of imaging, for those who were and were not diagnosed with hypertension no more than 3 years later. Aim 2. To evaluate automatically derived retinal vessel parameters as an early biomarker for the risk for development of diabetic retinopathy (defined as transition from less than moderate retinopathy AND no apparent macular edema according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Severity Scale) in at risk veterans with diabetes. We will compare this biomarker in retinal images from a population of 4000 veterans with diabetes, currently without DR, ~10% of who developed retinopathy no less than two years later while the remainder did not.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We will identify a random sample of 4500 veterans with diabetes from the Greater LA and Iowa City screening programs, who were imaged at least 3 years ago for DR screening, and did not have hypertension (AHA definition) at that time

Criteria

Inclusion Criteria:

  • veterans with diabetes
  • from the Greater LA and Iowa City screening programs
  • who were imaged at least 3 years ago for DR screening, and did not have hypertension (AHA definition) at that time

Exclusion Criteria:

  • random sample of 500 veterans with diabetes
  • from the Greater LA and Iowa City screening programs
  • who were imaged at least 3 years ago for DR screening, and did not have hypertension (AHA definition) at that time
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772173

Contacts
Contact: Michael Abramoff, MD Michael.Abramoff@va.gov
Contact: Kari A Steinkamp (319) 338-0581 ext 7678 Kari.Steinkamp2@va.gov

Locations
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Not yet recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Kari A Steinkamp    319-338-0581 ext 7678    Kari.Steinkamp2@va.gov   
Contact: Mark A Yorek, PhD    (319) 338-0581 ext 7666    mark.yorek@va.gov   
Principal Investigator: Michael Abramoff, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Abramoff, MD Iowa City VA Health Care System, Iowa City, IA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01772173     History of Changes
Other Study ID Numbers: C1084-P
Study First Received: January 16, 2013
Last Updated: February 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
diabetes
computer
retina
vessel
analysis

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014