Chest PainNCT00187954
WISE ARIC: Retinal Photography in Women With Chest Pain
An observational study of Chest Pain, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Chest Pain
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who participated in or are being screened for the WISE or EWISE or any ancillary studies
Who may be able to join
- 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
Who cannot join
- Unwilling to complete study required procedures
- Contraindication to adenosine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration
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.
Read the 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.
- Conditions
- Chest Pain
- Keywords
- women, chest pain, microvascular dysfunction, retinal photography, Retinal vascular function
- Medical subject headings
- Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Arteriole to venule ratio (AVR)
retinal arteriolar and venule diameters reflected as a ratio
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Eileen Handberg, PHD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187954
- Sponsor's protocol ID
- WISE ARIC
- Other IDs
- HL64924
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2005
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15990741
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration
- ClinicalTrials.gov ID
- NCT00187954
- Acronym / sponsor ID
- WISE ARIC
- Conditions
- Chest Pain
- Keywords
- women, chest pain, microvascular dysfunction, retinal photography, Retinal vascular function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- Jun 2003
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who participated in or are being screened for the WISE or EWISE or any ancillary studies
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to complete study required procedures
- Contraindication to adenosine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arteriole to venule ratio (AVR)
Time frame: baseline
retinal arteriolar and venule diameters reflected as a ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Background: PubMed 15990741Wattanakit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Handberg, PHD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arteriole to venule ratio (AVR) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.