NCT00187954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

11.3 years

First QC Date

September 14, 2005

Last Update Submit

August 11, 2021

Conditions

Chest Pain

Keywords

womenchest painmicrovascular dysfunctionretinal photographyRetinal vascular function

Outcome Measures

Primary Outcomes (1)

  • Arteriole to venule ratio (AVR)

    retinal arteriolar and venule diameters reflected as a ratio

    baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who participated in or are being screened for the WISE or EWISE or any ancillary studies

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling to complete study required procedures
  • Contraindication to adenosine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related 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. doi: 10.1016/j.ahj.2004.07.019.

    PMID: 15990741BACKGROUND

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eileen Handberg, PHD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

June 1, 2003

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

US(1)