Clinical trial NCT05199428: Optina Eye to Heart Connection
Official title: Use of a Deep Phenotyping Platform to Develop a Novel Retinal Imaging Test for Coronary Artery Disease: A Prospective Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Optina Diagnostics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Montreal Heart Institute
First posted: 2022-01-20
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters
timeFrame: 1.5 year
Secondary outcomes:
measure: Correlation between retinal imaging parameters and the number of vessels with a stenosis of 50% or greater as assessed by coronary angiography.
timeFrame: 1.5 year
measure: Correlation between retinal imaging parameters and the maximal severity of coronary artery stenosis as assessed by coronary angiography.
timeFrame: 1.5 year
measure: Sensitivity and specificity of new classification models based on retinal imaging parameters
timeFrame: 1.5 year
measure: Correlation between retinal imaging parameters and cognitive scores on the Montreal Cognitive Assessment (MoCA) and executive tasks
timeFrame: 1.5 year
measure: Sensitivity and specificity, among CAD subjects, of a pre-specified classification model, as well as new classification models
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal heart institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Jean-Claude Tardiff
role: PRINCIPAL_INVESTIGATOR
References: