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WISE ARIC: Retinal Photography in Women With Chest Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187954
First Posted: September 16, 2005
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
University of Florida
  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 ]
    retinal arteriolar and venule diameters reflected as a ratio


Enrollment: 160
Study Start Date: June 2003
Study Completion Date: September 2014
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187954


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
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
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: October 5, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms