Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 6:01 AM
Study NCT ID:
NCT05199428
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optina Eye to Heart Connection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of a pre-specified classification model based on retinal imaging parameters', 'timeFrame': '1.5 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between retinal imaging parameters and the number of vessels with a stenosis of 50% or greater as assessed by coronary angiography.', 'timeFrame': '1.5 year'}, {'measure': 'Correlation between retinal imaging parameters and the maximal severity of coronary artery stenosis as assessed by coronary angiography.', 'timeFrame': '1.5 year'}, {'measure': 'Sensitivity and specificity of new classification models based on retinal imaging parameters', 'timeFrame': '1.5 year', 'description': '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.'}, {'measure': 'Correlation between retinal imaging parameters and cognitive scores on the Montreal Cognitive Assessment (MoCA) and executive tasks', 'timeFrame': '1.5 year'}, {'measure': 'Sensitivity and specificity, among CAD subjects, of a pre-specified classification model, as well as new classification models', 'timeFrame': '1.5 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSubjects 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)\n\nSafety will be assessed through reporting of serious adverse events (SAEs) related to retinal imaging procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nSubjects 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and willingness to give written informed consent\n* Age 18 years or older at the time of informed consent\n* 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.\n* Patients having undergone clinically-indicated invasive coronary angiography or coronary computed tomography angiography within one month before consent signature\n\nExclusion Criteria:\n\n1. At Screening Visit 1:\n\n 1. Asymptomatic subjects\n 2. Previous coronary revascularization (e.g., coronary artery bypass graft surgery, stenting)\n 3. Subjects being evaluated for other cardiac diseases (e.g., valvular disease, cardiomyopathy)\n 4. Pregnant or breastfeeding women\n2. At Study Visit 2 or Ocular Exclusion Criteria:\n\n 1. Medium or high opacity of the lens\n 2. Bleeding in vitreous\n 3. Pupillary dilation inadequate or contraindicated\n 4. Deficient visual fixation\n 5. Refractive error outside of the range -15 to +15\n 6. Inability to obtain satisfactory images with the MHRC'}, 'identificationModule': {'nctId': 'NCT05199428', 'briefTitle': 'Optina Eye to Heart Connection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optina Diagnostics Inc.'}, 'officialTitle': 'Use of a Deep Phenotyping Platform to Develop a Novel Retinal Imaging Test for Coronary Artery Disease: A Prospective Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'DOC100469'}}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal heart institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jean-Claude Tardiff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optina Diagnostics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Montreal Heart Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}