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Completed

NCT Number: NCT05199428

Optina Eye to Heart Connection

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal heart institute

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • At Study Visit 2 or Ocular Exclusion Criteria:
  • 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

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters

    Time frame: 1.5 year

    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.

Secondary outcomes

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

    Time frame: 1.5 year

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

    Time frame: 1.5 year

  3. Sensitivity and specificity of new classification models based on retinal imaging parameters

    Time frame: 1.5 year

    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.

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

    Time frame: 1.5 year

  5. Sensitivity and specificity, among CAD subjects, of a pre-specified classification model, as well as new classification models

    Time frame: 1.5 year

    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.

Sponsors and collaborators

Lead sponsor

Optina Diagnostics Inc.

Industry

Collaborators

  • Montreal Heart Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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