WISE ARIC: Retinal Photography in Women With Chest Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Florida
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00187954
First received: September 14, 2005
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The purposes of this study are:

  • To correlate the severity of retinal arteriolar narrowing and other microvascular changes, as determined from retinal photographs and video imaging, to measures of coronary microvascular function in women evaluated for chest pain.
  • To evaluate measures of vascular compliance with applanation tonometry and photoplethysmography using a nasal alar probe.

Condition Phase
Chest Pain
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Arteriole to venule ratio (AVR) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    retinal arteriolar and venule diameters reflected as a ratio


Estimated Enrollment: 160
Study Start Date: June 2003
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Women who meet study eligibility criteria and provide written informed consent will have a baseline physical exam, including measurements of heart rate, blood pressure, weight. Medical history will be updated, specifically cardiovascular events (hospitalizations, procedures) since last contact and current medications. Patients will be scheduled for retinal photography. Those who are currently being screened and qualify for EWISE or other ancillary studies will have retinal photography scheduled as close to the index CFR as possible and prior to receiving randomized therapy.

The retinal photography will follow a standardized written protocol.

For the second protocol, 100 patients will be scheduled for an appointment in the Eye clinic where they will meet the Women's Ischemic Syndrome Evaluation (WISE)/Atherosclerosis Risk in Communities (ARIC) staff and complete the baseline information and have a brief physical examination. They will then have provocative testing completed with retinal imaging.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women who participated in or are being screened for the WISE or EWISE or any ancillary studies

Criteria

Inclusion Criteria:

  • Women who participated in or are being screened for the WISE or EWISE or any ancillary studies
  • Willing to provide written informed consent
  • Have recorded measurements of coronary flow reserve, with or without obstructive coronary disease

Exclusion Criteria:

  • Unwilling to complete study required procedures
  • Contraindication to adenosine
  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: NCT00187954

Contacts
Contact: Dana Leach, PhD 352-273-8930 dana.leach@medicine.ufl.edu
Contact: Eileen Handberg, PhD 352-273-9082 handbem@medicine.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Eileen Handberg, PhD         
Sub-Investigator: Karen Smith, MD         
Sub-Investigator: Carl J. Pepine, MD         
Sponsors and Collaborators
University of Florida
University of Pittsburgh
Investigators
Principal Investigator: Eileen Handberg, PHD University of Florida
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187954     History of Changes
Other Study ID Numbers: WISE ARIC, HL64924
Study First Received: September 14, 2005
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
women
chest pain
microvascular dysfunction
retinal photography
Retinal vascular function

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014