WISE ARIC: Retinal Photography in Women With Chest Pain

Completed

• Conditions: Chest Pain

• Registration Number: NCT00187954
• Lead Sponsor: University of Florida

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arteriole to venule ratio (AVR)	baseline	retinal arteriolar and venule diameters reflected as a ratio

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States