An observational study in Coronary Artery Disease, sponsored by Optina Diagnostics Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Optina Diagnostics Inc. · Observational
Among 269 studies in Coronary Artery Disease with a site in Canada — 27 open to participants now, 45 under way, 6 of them phase 3. Coronary Artery Disease · Canada.
Among the 269 studies in Coronary Artery Disease with a site in Canada, this one is the 25th largest by enrollment of the 62 observational ones that give a count, is one of 11 that started in 2022, is one of 62 observational ones, and was the 239th registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
Browse Coronary Artery Disease studies →27 of the 269 studies in Coronary Artery Disease with a site in Canada are open now. Recruiting first, the newest first:
Beijing Inno Medicine Co., Ltd. · Sites in Canada, United States, Australia and 1 more country
Ages 18–80
Montreal Heart Institute · Sites in Canada
Ages 40+
University of Calgary · Sites in Canada
Ages 18+
University of Calgary · Sites in Canada
Ages 18+
Medtronic Vascular · Sites in Canada, United States, Germany and 6 more countries
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
269 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 23 · Phase 3 51 · Phase 4 29
First in 1998; this study’s year is marked. 11 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 308 is close to the median of 323 across 1,688 observational studies indexed under Coronary Artery Disease.
Median enrollment 208 across the 207 interventional studies, 224 across the 62 observational. Of the 195 that completed or were terminated, 56 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
70 of 269 have an industry lead sponsor. The 10 most frequent:
Optina Diagnostics Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Optina Diagnostics Inc. has 1 study filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
14 of the studies in Coronary Artery Disease with a site in Canada that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05427084Phase 3Ottawa Heart Institute Research CorporationCanagliflozin Targeting Vascular Inflammation | 2026-12 |
| NCT07524335Phase 3Montreal Heart InstituteAspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial | 2027-07-21 |
| NCT01114269Brigham and Women's HospitalPRE-DETERMINE Cohort Study | 2026-11 |
| NCT04464655McGill University Health Centre/Research Institute of the McGill University Health CentreA 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease | 2026-12-19 |
| NCT06743672University of CalgaryDevelopment of a Novel Risk Prediction Tool for Emergency Department Patients Symptoms of Coronary Artery Disease | 2026-12-31 |
Add all 14 to your calendar (.ics) → With an account.
Among the 269 studies in Coronary Artery Disease with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
At Screening Visit 1:
At Study Visit 2 or Ocular Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters
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.
Time frame: 1.5 year
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
Correlation between retinal imaging parameters and the maximal severity of coronary artery stenosis as assessed by coronary angiography.
Time frame: 1.5 year
Sensitivity and specificity of new classification models based on retinal imaging parameters
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.
Time frame: 1.5 year
Correlation between retinal imaging parameters and cognitive scores on the Montreal Cognitive Assessment (MoCA) and executive tasks
Time frame: 1.5 year
Sensitivity and specificity, among CAD subjects, of a pre-specified classification model, as well as new classification models
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.
Time frame: 1.5 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Mar 2024, 21 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Optina Diagnostics Inc.