Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-21 @ 8:05 PM
Study NCT ID:
NCT03939351
Status:
WITHDRAWN
Last Update Posted:
2022-01-04
First Post:
2019-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020212', 'term': 'Carotid Artery Injuries'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020214', 'term': 'Cerebrovascular Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'withdrawal of the project', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'homolateral retinal and choroidal vascular density (%)', 'timeFrame': '1 month', 'description': 'Finely describe the homolateral retinal and choroidal vascular density changes in the macula in OCT-angiography at 1 month after revascularization on the internal carotid artery'}], 'secondaryOutcomes': [{'measure': 'Vascular density of contralateral eye (%)', 'timeFrame': '1 month', 'description': 'Describe the variations of vascular density in OCT-A on the controlateral eye after revascularization'}, {'measure': 'Subfoveal choroidal thickness', 'timeFrame': '1 month', 'description': 'Describe the variations of subfoveal choroidal thickness in OCT-EDI (Enhanced depth imaging optical coherence tomography) after revascularization'}, {'measure': 'Optical fiber thickness', 'timeFrame': '1 month', 'description': 'Describe the variations in homolateral optical fiber thickness in RNFL ( Retinal Nerve Fiber Layer)OCT after revascularization'}, {'measure': 'retinal and choroidal vascular density (%)', 'timeFrame': '1 month', 'description': 'Compare the retinal and choroidal variations according to the proposed procedure: conventional surgery or angioplasty and stenting'}, {'measure': 'Intraocular pressure (mm Hg)', 'timeFrame': '1 month', 'description': 'Compare changes in intraocular pressure before and after revascularization procedure'}, {'measure': 'Retinal and choroidal vascular density (%) according to the type of carotid stenosis', 'timeFrame': '1 month', 'description': 'Compare changes in retinal and choroidal vascular density according to the type of carotid stenosis: symptomatic stenosis, asymptomatic stenosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Artery Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the changes in morphology and Retinal vascularization after revascularization of the internal carotid artery. Indeed, the stenosis of the internal carotid artery can lead to ophthalmological charts. The underlying hypothesis is that revascularization of the internal carotid artery would improve ipsilateral and retinal homolateral perfusion in the short term. The OCT-angiography technique accurately studies the retinal vasculature and also assesses the risk of retinal and choroidal embolism, which is recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.', 'detailedDescription': 'The stenosis of the internal carotid artery is a frequent and potentially serious pathology (TIA, ischemic stroke, death), which can also be manifested by ophthalmological charts, foremost among which are transient monocular blindness.\n\nThe most common etiology of this stenosis remains the atheromatous pathology, whose treatment, depending on the symptomatic or non-symptomatic nature of the stenosis, includes, among other things, a revascularization procedure that may be surgical (endarterectomy, reference treatment) or guided by radiology (angioplasty and carotid stent placement)\n\nFrom the anatomical point of view, the internal carotid artery notably has for branching the ophthalmological artery, which itself will give birth:\n\n* at the central artery of the retina: role in the vascularization of the inner layers of the retina\n* posterior ciliary arteries: role in the choroidal vasculature and outer layers of the retina.\n\nVery little knowledge at the present time relates changes in retinal and choroidal vascularization after a revascularization procedure on the internal carotid artery OCT-angiography is a non-invasive imaging technique that is now part of investigative examinations in retinal imaging. This technique makes it possible to study the macular and choroidal retinal vascularization with precision without injection of contrast medium and thus allows to deepen the knowledge in medical fields where the exploration was until now limited because of the invasiveness of the examinations.\n\nThe hypothesis of this project is that revascularization of the internal carotid artery would improve retinal and choroidal ipsilateral perfusion in the short term (1 month postoperatively), as assessed by OCT-angiography. OCT-angiography could also be used to assess retinal and choroidal embolism risk, usually recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be proposed to patients for whom revascularization has been performed by vascular surgeons (symptomatic, asymptomatic carotid stenosis)', 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patient aged 18 or over\n* Indication of treatment with a carotid revascularization procedure (conventional surgery or angioplasty and stent)\n* Acceptance to participate in the protocol\n\nExclusion Criteria:\n\n* Associated retinal ophthalmological pathology: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, CRSC (Central serous chorioretinopathy)\n* Refusal to participate in the study\n* Not affiliated to a social security scheme'}, 'identificationModule': {'nctId': 'NCT03939351', 'acronym': 'CAROCT-A', 'briefTitle': 'Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Multimodal Imaging Analysis, OCT-angiography (Optical Coherence Tomography) and SD-OCT (Spectral Domain Optical Coherence Tomography), of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery', 'orgStudyIdInfo': {'id': 'CAROCT-A'}, 'secondaryIdInfos': [{'id': '2018-A00777-48', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'OCT-angiography and SD-OCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Performing an OCT-angiography and SD-OCT examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri-Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}