Optina Eye to Heart Connection

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199428
• Other study ID #: DOC100469
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Optina Diagnostics Inc.
• Contact: Shannon Campbell
• Phone: 514-889-4994
• Email: scampbell[@]optinadx.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Montreal heart institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Optina Diagnostics Inc.	Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation between retinal imaging parameters and the maximal severity of coronary artery stenosis as assessed by coronary angiography.		1.5 year
Secondary	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
Secondary	Correlation between retinal imaging parameters and cognitive scores on the Montreal Cognitive Assessment (MoCA) and executive tasks		1.5 year
Secondary	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