WISE ARIC: Retinal Photography in Women With Chest Pain

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187954
• Other study ID #: WISE ARIC
• Secondary ID: HL64924
• Status: Completed
• Start date: June 2003
• Est. completion date: September 2014

Study information

• Verified date: August 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wattanakit K, Folsom AR, Chambless LE, Nieto FJ. Risk factors for cardiovascular event recurrence in the Atherosclerosis Risk in Communities (ARIC) study. Am Heart J. 2005 Apr;149(4):606-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arteriole to venule ratio (AVR)	retinal arteriolar and venule diameters reflected as a ratio	baseline