Optina Eye to Heart Connection

Status Recruiting

Clinical Trial Summary

This is a prospective cross-sectional, single-center retinal imaging study expecting to enroll approximately 400 male and female subjects ≥ 18 years of age. Subjects having undergone clinically-indicated coronary angiography or coronary computed tomography angiography (CCTA) within one month of consent at the Montreal Heart Institute (MHI) will be screened for inclusion in the study.

Clinical Trial Description

This is a prospective cross-sectional, single-center retinal imaging study expecting to enroll aproximately 400 (280 CAD and 120 control) male and female subjects ≥ 18 years of age. Subjects having undergone clinically-indicated invasive coronary angiography or coronary computed tomography angiography (CCTA) within one month of signed consent will be screened for inclusion in the study. Subjects will be recruited at the Montreal Heart Institute (MHI). During the screening visit, the investigator will review inclusion/exclusion criteria and the following information will be collected: demographic data including age and sex, relevant medical history including risk factors (hypertension, diabetes, dyslipidemia, smoking and obesity), history of CAD, concomitant cardiovascular medications and laboratory tests (lipid profile, fasting glucose) Subjects who provide written informed consent will undergo cognitive evaluation and an ophthalmic examination to identify any ocular exclusion criteria. All eligible subjects will then undergo hyperspectral retinal imaging using a Metabolic Hyperspectral Retinal Camera (MHRC) Safety will be assessed through reporting of serious adverse events (SAEs) related to retinal imaging procedures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05199428
Study type	Observational
Source	Optina Diagnostics Inc.
Contact	Shannon Campbell
Phone	514-889-4994
Email	scampbell@optinadx.com
Status	Recruiting
Phase
Start date	February 15, 2022
Completion date	March 31, 2024

View Details

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