Retinal DiseaseEYE-MI TNTNCT04233619
Correlation of Microvascular Ophthalmic Disease With Macrovascular Coronary Artery Disease in Trinidad
An observational study of Retinal Disease, run by The University of The West Indies at 1 site in Trinidad and Tobago.
Trial summary
Coronary artery disease (CAD) is the leading cause of death in Trinidad and Tobago. Early detection and management can help improve morbidity and mortality. Retinal artery microvascular disease has been shown to directly correlate with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- optical coherence tomography
- How many people
- 184 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 1 May 2019to 15 Apr 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both male and female gender; all racial/ethnic groups including Afro-Caribbean, Indo-Caribbean, Asians, Caucasians, Hispanics and mixed ethnicities will be included in the study. Potential subjects will be identified from the Catheterization Lab at the Eric Williams Medical Sciences Complex. Patients who underwent or undergoing coronary angiography at the Eric Williams Medical Sciences Complex from May 1st 2019 to April 30th 2021.
Who may be able to join
- Patients 18 years and over,
- Patients who had a coronary angiogram done at the Catheterisation lab at the Eric Williams Medical Sciences Complex during the study period.
Who cannot join
- Patients who do not give informed consent to participate in the study,
- Patients who are acutely unwell,
- Patients who are symptomatic for Coronary Artery Disease,
- Patients with bilateral cataract.
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
The University of the West Indies
Saint Augustine
About this study
Official title: Correlation of Microvascular Ophthalmic Disease With Macrovascular Coronary Artery Disease in Trinidad: The EYE-MI TNT Study
Coronary artery disease (CAD) is the leading cause of death in Trinidad and Tobago. Early detection and management can help improve morbidity and mortality. Retinal artery microvascular disease has been shown to directly correlate with coronary artery disease. Retinal artery calibre screening via the Optic Coherence Tomography (OCT) will provide a non-invasive method of diagnosing CAD.
Read the detailed description
Cardiovascular disease is the number one cause of death in Trinidad and Tobago. There has been a 20.4% increase in cardiovascular deaths from 2007 to 2017(1). Prevention of non-communicable diseases decreases the burden and progression to cardiovascular disease. Prevention of death from cardiovascular disease can also be decreased by early detection, intervention and appropriate management of coronary artery disease.
Due to the burden of the cost of health care on the economy of Trinidad and Tobago, patients are required to go on a waitlist to receive specialist medical investigation such as a coronary angiogram. This investigation is only offered at one public health facility in Trinidad and Tobago, the Eric Williams Medical Sciences Complex.
Coronary artery disease is graded by a scoring system, the SYNTAX score, which is calculated based on the assessment of the complexity of coronary artery disease by coronary angiography (2). In a study done on 173 patients- the EYE-MI study, patients with the lowest retinal vascular density had a higher SYNTAX score, indicating a direct correlation between retinal artery calibre and the severity of coronary artery disease (3).
Retinal artery calibre is assessed using the Optical Coherence Tomography. It is a relatively affordable non-invasive test performed by an Ophthalmologist that allows three dimensional imaging of the retinal vasculature. It is recommended by the American Association of Ophthalmologist for assessing retinal disease (4). This test is not available in the public health care system in Trinidad and Tobago.
In a country with a Human Capital Index of 0.61 (5), and cardiovascular disease being the number one cause of death, a cheaper non-invasive tool to screen for coronary artery disease would be of benefit to the population. We postulate that there is a direct correlation between the retinal artery calibre assessed by the Optical Coherence Tomography and the severity of coronary artery disease. There are not many studies assessing this relationship and this study will promote further avenues for research into this correlation.
- Conditions
- Retinal Disease
- Being tested
- optical coherence tomography
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDiagnostic test
non-invasive test performed by an Ophthalmologist that allows three-dimensional imaging of the retinal vasculature
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there is a direct correlation between retinal artery calibre and coronary artery disease
Compare SYNTAX score and OCT results to determine correlation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 May 2019
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233619
- Sponsor's protocol ID
- CEC819/01/19
- Acronym
- EYE-MI TNT
- Status last verified
- Feb 2021
- First submitted
- 14 Jan 2020
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yammine M, Itagaki S, Pawale A, Toyoda N, Reddy RC. SYNTAX score may predict the severity of atherosclerosis of the ascending aorta. J Thorac Dis. 2017 Oct;9(10):3859-3865. doi: 10.21037/jtd.2017.09.17.
PubMed 29268395Michelson EL, Morganroth J, Nichols CW, MacVaugh H 3rd. Retinal arteriolar changes as an indicator of coronary artery disease. Arch Intern Med. 1979 Oct;139(10):1139-41.
PubMed 485746Seecheran NA, Rafeeq S, Maharaj N, Swarath S, Seecheran V, Seecheran R, Seebalack V, Jagdeo CL, Seemongal-Dass R, Quert AYL, Giddings S, Ramlackhansingh A, Sandy S, Motilal S, Seemongal-Dass R. Correlation of RETINAL Artery Diameter with Coronary Artery Disease: The RETINA CAD Pilot Study-Are the Eyes the Windows to the Heart? Cardiol Ther. 2023 Sep;12(3):499-509. doi: 10.1007/s40119-023-00320-x. Epub 2023 Jun 15.
PubMed 37318673
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Microvascular Ophthalmic Disease With Macrovascular Coronary Artery Disease in Trinidad: The EYE-MI TNT Study
- ClinicalTrials.gov ID
- NCT04233619
- Acronym / sponsor ID
- EYE-MI TNT / CEC819/01/19
- Conditions
- Retinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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.
Coronary artery disease (CAD) is the leading cause of death in Trinidad and Tobago. Early detection and management can help improve morbidity and mortality. Retinal artery microvascular disease has been shown to directly correlate with coronary artery disease. Retinal artery calibre screening via the Optic Coherence Tomography (OCT) will provide a non-invasive method of diagnosing CAD.
Detailed description
Cardiovascular disease is the number one cause of death in Trinidad and Tobago. There has been a 20.4% increase in cardiovascular deaths from 2007 to 2017(1). Prevention of non-communicable diseases decreases the burden and progression to cardiovascular disease. Prevention of death from cardiovascular disease can also be decreased by early detection, intervention and appropriate management of coronary artery disease.
Due to the burden of the cost of health care on the economy of Trinidad and Tobago, patients are required to go on a waitlist to receive specialist medical investigation such as a coronary angiogram. This investigation is only offered at one public health facility in Trinidad and Tobago, the Eric Williams Medical Sciences Complex.
Coronary artery disease is graded by a scoring system, the SYNTAX score, which is calculated based on the assessment of the complexity of coronary artery disease by coronary angiography (2). In a study done on 173 patients- the EYE-MI study, patients with the lowest retinal vascular density had a higher SYNTAX score, indicating a direct correlation between retinal artery calibre and the severity of coronary artery disease (3).
Retinal artery calibre is assessed using the Optical Coherence Tomography. It is a relatively affordable non-invasive test performed by an Ophthalmologist that allows three dimensional imaging of the retinal vasculature. It is recommended by the American Association of Ophthalmologist for assessing retinal disease (4). This test is not available in the public health care system in Trinidad and Tobago.
In a country with a Human Capital Index of 0.61 (5), and cardiovascular disease being the number one cause of death, a cheaper non-invasive tool to screen for coronary artery disease would be of benefit to the population. We postulate that there is a direct correlation between the retinal artery calibre assessed by the Optical Coherence Tomography and the severity of coronary artery disease. There are not many studies assessing this relationship and this study will promote further avenues for research into this correlation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both male and female gender; all racial/ethnic groups including Afro-Caribbean, Indo-Caribbean, Asians, Caucasians, Hispanics and mixed ethnicities will be included in the study. Potential subjects will be identified from the Catheterization Lab at the Eric Williams Medical Sciences Complex. Patients who underwent or undergoing coronary angiography at the Eric Williams Medical Sciences Complex from May 1st 2019 to April 30th 2021.
Key inclusion criteria (2 listed)
- Patients 18 years and over,
- Patients who had a coronary angiogram done at the Catheterisation lab at the Eric Williams Medical Sciences Complex during the study period.
Key exclusion criteria (4 listed)
- Patients who do not give informed consent to participate in the study,
- Patients who are acutely unwell,
- Patients who are symptomatic for Coronary Artery Disease,
- Patients with bilateral cataract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomographynon-invasive test performed by an Ophthalmologist that allows three-dimensional imaging of the retinal vasculature | Diagnostic test | – |
Primary outcome
To determine if there is a direct correlation between retinal artery calibre and coronary artery disease
Time frame: 2 years
Compare SYNTAX score and OCT results to determine correlation
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 25 Aug 2023.
- Background: PubMed 29268395Yammine M, Itagaki S, Pawale A, Toyoda N, Reddy RC. SYNTAX score may predict the severity of atherosclerosis of the ascending aorta. J Thorac Dis. 2017 Oct;9(10):3859-3865. doi: 10.21037/jtd.2017.09.17.
- Background: PubMed 485746Michelson EL, Morganroth J, Nichols CW, MacVaugh H 3rd. Retinal arteriolar changes as an indicator of coronary artery disease. Arch Intern Med. 1979 Oct;139(10):1139-41.
- Derived from this study: PubMed 37318673Seecheran NA, Rafeeq S, Maharaj N, Swarath S, Seecheran V, Seecheran R, Seebalack V, Jagdeo CL, Seemongal-Dass R, Quert AYL, Giddings S, Ramlackhansingh A, Sandy S, Motilal S, Seemongal-Dass R. Correlation of RETINAL Artery Diameter with Coronary Artery Disease: The RETINA CAD Pilot Study-Are the Eyes the Windows to the Heart? Cardiol Ther. 2023 Sep;12(3):499-509. doi: 10.1007/s40119-023-00320-x. Epub 2023 Jun 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Retinal Disease, run by The University of The West Indies at 1 site in Trinidad and Tobago.
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 2 inclusion and 4 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 25 Aug 2023. 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 Trinidad and Tobago. 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?
To determine if there is a direct correlation between retinal artery calibre and coronary artery disease (time frame: 2 years). 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 NCT04233619, which also lists 3 linked publications.
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 25 Aug 2023.