Status:
COMPLETED
Optina Eye to Heart Connection
Lead Sponsor:
Optina Diagnostics Inc.
Collaborating Sponsors:
Montreal Heart Institute
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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-indica...
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 un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 22 2024
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT05199428
Start Date
June 15 2022
End Date
March 22 2024
Last Update
May 23 2024
Active Locations (1)
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1
Montreal heart institute
Montreal, Quebec, Canada