Optina Eye to Heart Connection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-15

Study Completion Date

2024-03-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No