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OpenTrials
Completed

NCT Number: NCT00187954

WISE ARIC: Retinal Photography in Women With Chest Pain

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.

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Key information

Conditions

Chest Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Arteriole to venule ratio (AVR)

    Time frame: baseline

    retinal arteriolar and venule diameters reflected as a ratio

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2005
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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