NCT04233619

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

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

May 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

August 25, 2023

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

January 14, 2020

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Interventions

non-invasive test performed by an Ophthalmologist that allows three-dimensional imaging of the retinal vasculature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of the West Indies

Saint Augustine, Trinidad and Tobago

Location

Related Publications (3)

  • 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.

    PMID: 29268395BACKGROUND
  • Michelson 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.

    PMID: 485746BACKGROUND
  • Seecheran 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.

MeSH Terms

Conditions

Retinal Diseases

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

May 1, 2019

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

August 25, 2023

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations