Optina Eye to Heart Connection

Use of a Deep Phenotyping Platform to Develop a Novel Retinal Imaging Test for Coronary Artery Disease: A Prospective Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed 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 Type: Observational
• Enrollment (Actual): 308

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A sample size of 400 (280 CAD and 120 control) subjects was chosen to allow for the estimation of the sensitivity and specificity of classification models with an acceptable precision, the latter defined as the corresponding 95% confidence intervals.

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.

Description

Inclusion Criteria:

• Ability and willingness to give written informed consent
• Age 18 years or older at the time of informed consent
• Stable (non-emergent) typical or atypical symptoms suspicious for CAD (e.g., chest pain, chest tightness, chest burning, shoulder pain, palpitations, jaw pain, or non-chest pain symptoms such as dyspnea or worsening effort tolerance.
• Patients having undergone clinically-indicated invasive coronary angiography or coronary computed tomography angiography within one month before consent signature

Exclusion Criteria:

1. At Screening Visit 1:

   1. Asymptomatic subjects
   2. Previous coronary revascularization (e.g., coronary artery bypass graft surgery, stenting)
   3. Subjects being evaluated for other cardiac diseases (e.g., valvular disease, cardiomyopathy)
   4. Pregnant or breastfeeding women

2. At Study Visit 2 or Ocular Exclusion Criteria:

   1. Medium or high opacity of the lens
   2. Bleeding in vitreous
   3. Pupillary dilation inadequate or contraindicated
   4. Deficient visual fixation
   5. Refractive error outside of the range -15 to +15
   6. Inability to obtain satisfactory images with the MHRC

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters	Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters to discriminate between control subjects and subjects with CAD (defined as stenosis in at least one epicardial vessel of 50% or greater) as assessed by coronary angiography.	1.5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between retinal imaging parameters and the number of vessels with a stenosis of 50% or greater as assessed by coronary angiography.		1.5 year
Correlation between retinal imaging parameters and the maximal severity of coronary artery stenosis as assessed by coronary angiography.		1.5 year
Sensitivity and specificity of new classification models based on retinal imaging parameters	Sensitivity and specificity of new classification models based on retinal imaging parameters to discriminate between control subjects and subjects with CAD (defined as stenosis in at least one epicardial vessel of 50% or greater) as assessed by coronary angiography.	1.5 year
Correlation between retinal imaging parameters and cognitive scores on the Montreal Cognitive Assessment (MoCA) and executive tasks		1.5 year
Sensitivity and specificity, among CAD subjects, of a pre-specified classification model, as well as new classification models	Sensitivity and specificity, among CAD subjects, of a pre-specified classification model, as well as of new classification models, based on retinal imaging parameters to discriminate between subjects with less severe CAD (less vessels with a stenosis of 50% or greater) and subjects with more severe CAD (more vessels with a stenosis of 50% or greater) as assessed by coronary angiography.	1.5 year

Collaborators and Investigators

• Sponsor: Optina Diagnostics Inc.
• Collaborators: Montreal Heart Institute
• Investigators: Principal Investigator: Jean-Claude Tardiff, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: DOC100469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No