Clinical trial NCT00187954: WISE ARIC: Retinal Photography in Women With Chest Pain
Official title: Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Keywords: women
chest pain
microvascular dysfunction
retinal photography
Retinal vascular function
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2005-09-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who participated in or are being screened for the WISE or EWISE or any ancillary studies

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.

Eligibility 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

Primary outcomes:
measure: Arteriole to venule ratio (AVR)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Eileen Handberg, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ahj.2004.07.019.