WISE ARIC: Retinal Photography in Women With Chest Pain
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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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration |
- Arteriole to venule ratio (AVR) [ Time Frame: baseline ] [ Designated as safety issue: No ]retinal arteriolar and venule diameters reflected as a ratio
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women who participated in or are being screened for the WISE or EWISE or any ancillary studies
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| Contact: Dana Leach, PhD | 352-273-8930 | dana.leach@medicine.ufl.edu |
| Contact: Eileen Handberg, PhD | 352-273-9082 | handbem@medicine.ufl.edu |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Eileen Handberg, PhD | |
| Sub-Investigator: Karen Smith, MD | |
| Sub-Investigator: Carl J. Pepine, MD | |
| 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 |
| Study First Received: | September 14, 2005 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
women chest pain microvascular dysfunction retinal photography Retinal vascular function |
Additional relevant MeSH terms:
|
Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013