Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT06692751
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients with Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal vascular density by "inner vessel length density" determined by OCT-A', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microvascular Angina']}, 'descriptionModule': {'briefSummary': 'Microvascular angina is thought to affect around 112 million patients worldwide. However, this figure is underestimated due to the difficulty of making the diagnosis. It is a pathology caused by an alteration in the microcirculation of the heart muscle, which is not detectable on a standard coronary angiogram.\n\nIn view of its prognostic, therapeutic and medico-economic value, scientific societies currently recommend invasive measurement of the microcirculatory resistance index (MRI) to diagnose microvascular angina, in the absence of significant lesions on coronary angiography.\n\nSeveral research teams, including our own, have shown that cardiovascular risk is associated with alterations in the vascularization of the small vessels (microcirculation) of the retina. Unlike the study of cardiac vessels, the study of retinal microcirculation using fundus photography (OCT-A) is simple, rapid, non-invasive and inexpensive. It appears to be an interesting alternative to the measurement of IMR for the diagnosis of microvascular angina.\n\nThis hypothesis has never yet been tested. The demonstration of an association between a decrease in retinal vascular density measured by OCT-A and an alteration in coronary microvascular function measured by IMR would pave the way for a completely non-invasive diagnosis of patients.\n\nThis is an observational, cohort, prospective, single-center pilot study comparing people who have received an IMR measurement as part of INOCA.\n\nIt is planned to include 158 participants. The overall follow-up period for each patient in the research is 12 months.\n\nIn routine care, IMR is measured during coronary angiography in patients presenting with ischemia on a non-invasive test and/or stress symptoms such as angina or dyspnea, for whom coronary angiography does not reveal any significant epicardial lesion.\n\nFollowing this examination, two groups will be formed: a group with an IMR\\<25 and a group with an IMR≥25. Clinically, the study aims to determine the potential role of retinal OCT-A as a non-invasive examination for the diagnosis and/or follow-up of INOCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at Dijon University Hospital, who received an IMR measurement as part of INOCA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients managed at Dijon University Hospital, having had an IMR measurement as part of INOCA during a coronary angiographic examination, consecutively includible, without angiographically or functionally significant coronary epicardial lesion (FFR \\< 0.80) explaining the clinical picture (= INOCA)\n* Person having given oral consent\n* Adult\n\nExclusion Criteria:\n\n* Person not affiliated or not benefiting from a social security scheme\n* Person subject to a legal protection measure (curatorship, guardianship) or a safeguard of justice measure\n* Pregnant or breast-feeding women\n* An adult incapable or unable to give consent\n* Person with macular or retinal pathology, or severe bilateral myopia\n* Person with genetic or idiopathic cardiomyopathy (dilated, hypertrophic or restrictive cardiomyopathy)'}, 'identificationModule': {'nctId': 'NCT06692751', 'acronym': 'EYE-NOCA', 'briefTitle': 'The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients with Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients with Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).', 'orgStudyIdInfo': {'id': "POMMIER J'InvEST-I 2023"}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IMR<25', 'description': 'People without microvascular angina', 'interventionNames': ['Biological: Blood sampling', 'Procedure: Ophthalmological examination', 'Other: angina severity questionnaire']}, {'label': 'IMR≥25', 'description': 'People with microvascular angina', 'interventionNames': ['Biological: Blood sampling', 'Procedure: Ophthalmological examination', 'Other: angina severity questionnaire']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': '2 tubes of 5 mL', 'armGroupLabels': ['IMR<25', 'IMR≥25']}, {'name': 'Ophthalmological examination', 'type': 'PROCEDURE', 'description': 'angiographic optical coherence tomography (OCT-A) on both eyes after pupil dilation.\n\nAn optional 20-30 minute WLR may be offered following OCT-A.', 'armGroupLabels': ['IMR<25', 'IMR≥25']}, {'name': 'angina severity questionnaire', 'type': 'OTHER', 'description': 'at inclusion, 3 months and 1 year Estimated filling time: 2 minutes', 'armGroupLabels': ['IMR<25', 'IMR≥25']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaut POMMIER', 'role': 'CONTACT', 'email': 'thibaut.pommier@chu-dijon.fr', 'phone': '0380293031'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Thibaut POMMIER', 'role': 'CONTACT', 'email': 'thibaut.pommier@chu-dijon.fr', 'phone': '0380293031'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}