Optina Eye to Heart Connection

NCT05199428 | Completed

• 1 other identifier: DOC100469
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

  1.5 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• At Screening Visit 1:
• Asymptomatic subjects
• Previous coronary revascularization (e.g., coronary artery bypass graft surgery, stenting)
• Subjects being evaluated for other cardiac diseases (e.g., valvular disease, cardiomyopathy)
• Pregnant or breastfeeding women
• Medium or high opacity of the lens
• Bleeding in vitreous
• Pupillary dilation inadequate or contraindicated
• Deficient visual fixation
• Refractive error outside of the range -15 to +15
• Inability to obtain satisfactory images with the MHRC

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead
• Montreal Heart Institute: collaborator

Study Sites (1)

Montreal heart institute

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jean-Claude Tardiff

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 20, 2022
• Study Start: June 15, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

CA (1)