Optina Eye to Heart Connection

• Sponsor: Optina Diagnostics Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05199428
• Collaborator: Montreal Heart Institute (Other)
• Enrollment: 400
• Anticipated Duration (Months): 14.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Use of a Deep Phenotyping Platform to Develop a Novel Retinal Imaging Test for Coronary Artery Disease: A Prospective Cross-Sectional Study
• Anticipated Study Start Date: Feb 15, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Outcome Measures

Primary Outcome Measures

1. Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters to discriminate between control subjects and subjects with CAD as assessed by coronary angiography. [1 year]

Secondary Outcome Measures

1. Correlation between retinal imaging parameters and the number of vessels with a stenosis of 50% or greater as assessed by coronary angiography. [1 year]

2. Correlation between retinal imaging parameters and the maximal severity of coronary artery stenosis as assessed by coronary angiography. [1 year]

3. Sensitivity and specificity of new classification models based on retinal imaging parameters to discriminate between control subjects and subjects with CAD as assessed by coronary angiography. [1 year]

4. Correlation between retinal imaging parameters and cognitive scores on the Montreal Cognitive Assessment (MoCA) and executive tasks. [1 year]

5. Sensitivity and specificity, among CAD subjects to discriminate between subjects with less severe CAD and subjects with more severe CAD as assessed by coronary angiography. [1 year]

   Sensitivity and specificity using pre-specified classification model as well as of new classification models based on retinal imaging parameters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

2. Asymptomatic subjects

3. Previous coronary revascularization (e.g., coronary artery bypass graft surgery, stenting)

4. Subjects being evaluated for other cardiac diseases (e.g., valvular disease, cardiomyopathy)

5. Pregnant or breastfeeding women

6. At Study Visit 2 or Ocular Exclusion Criteria:

7. Medium or high opacity of the lens

8. Bleeding in vitreous

9. Pupillary dilation inadequate or contraindicated

10. Deficient visual fixation

11. Refractive error outside of the range -15 to +15

12. Inability to obtain satisfactory images with the MHRC

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Optina Diagnostics Inc.
• Montreal Heart Institute

Investigators

• Principal Investigator: Jean-Claude Tardiff, Montreal Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Optina Diagnostics Inc.
• ClinicalTrials.gov Identifier: NCT05199428
• Other Study ID Numbers: DOC100469
• First Posted: Jan 20, 2022
• Last Update Posted: Jan 20, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Jan 20, 2022