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Correlation of Microvascular Ophthalmic Disease With Macrovascular Coronary Artery Disease in Trinidad (EYE-MI TNT)

ClinicalTrials.gov ID NCT04233619
Sponsor The University of The West Indies
Information provided by The University of The West Indies (Responsible Party)
Last Update Posted 2023-08-25
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Study Overview

Brief 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. 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.

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Official Title
Correlation of Microvascular Ophthalmic Disease With Macrovascular Coronary Artery Disease in Trinidad: The EYE-MI TNT Study
Conditions
Retinal Disease
Intervention / Treatment
  • Diagnostic Test: optical coherence tomography
  • Diagnostic Test: optical coherence tomography
Other Study ID Numbers
  • CEC819/01/19
Study Start (Actual)
2019-05-01
Primary Completion (Actual)
2021-04-15
Study Completion (Actual)
2021-04-15
Enrollment (Actual)
184
Study Type
Observational

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  1. Patients 18 years and over,
  2. Patients who had a coronary angiogram done at the Catheterisation lab at the Eric Williams Medical Sciences Complex during the study period.

Exclusion Criteria:

  1. Patients who do not give informed consent to participate in the study,
  2. Patients who are acutely unwell,
  3. Patients who are symptomatic for Coronary Artery Disease,
  4. Patients with bilateral cataract.
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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.
Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Observational Model : Case-Control
Time Perspective: Cross-Sectional

Groups and Interventions

Intervention/Treatment
Intervention/Treatment
Diagnostic Test: optical coherence tomography
  • non-invasive test performed by an Ophthalmologist that allows three-dimensional imaging of the retinal vasculature

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
To determine if there is a direct correlation between retinal artery calibre and coronary artery diseaseCompare SYNTAX score and OCT results to determine correlation2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
The University of The West Indies

Publications

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2020-01-14
First Submitted that Met QC Criteria
2020-01-14
First Posted
2020-01-18
Study Record Updates
Last Update Submitted that met QC Criteria
2023-08-24
Last Update Posted
2023-08-25
Last Verified
2021-02

More Information

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Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No