NCT05199428Completed
Optina Eye to Heart Connection
Use of a Deep Phenotyping Platform to Develop a Novel Retinal Imaging Test for Coronary Artery Disease: A Prospective Cross-Sectional Study
Source: ClinicalTrials.gov · Last updated 23 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 308 (actual)
- First submitted
- 20 Dec 2021
- Start date
- 15 Jun 2022
- Primary completion date
- 22 Mar 2024
- Lead sponsor
- Optina Diagnostics Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT05199428
What you commit to
- Study type: Observational
- Participants enrolled: 308
- From 15 Jun 2022 to the primary completion date, 22 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.