Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05835869
Status:
UNKNOWN
Last Update Posted:
2023-07-06
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], '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': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional retinal changes', 'timeFrame': '1 week and 3 months', 'description': 'To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy'}], 'secondaryOutcomes': [{'measure': 'Retinal vascular density changes', 'timeFrame': '1 week and 3 months', 'description': 'To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Stenosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years old\n* Carotid stenosis diagnosis with indication to perform carotid endarterectomy\n* informed consent form signing\n\nExclusion Criteria:\n\n* age \\<18 years old\n* recurrent intraocular inflammation\n* retinal disease\n* optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images\n* unstable fixation\n* spheric refractive error \\> +/- 6 D spheric and/or +/- 3 D cylinder\n* history of prior ocular surgery\n* refusal of signing informed consent form'}, 'identificationModule': {'nctId': 'NCT05835869', 'acronym': 'CAS-AOCT', 'briefTitle': 'Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study', 'orgStudyIdInfo': {'id': '5532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study population', 'interventionNames': ['Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram']}], 'interventions': [{'name': 'Optical coherence tomography angiography and pattern electroretinogram', 'type': 'DIAGNOSTIC_TEST', 'description': 'Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy', 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Baldascino, MD', 'role': 'CONTACT', 'email': 'antonio.baldascino@policlinicogemelli.it', 'phone': '+393388771472'}], 'facility': 'Policlinico Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Antonio Baldascino, MD', 'role': 'CONTACT', 'email': 'antonio.baldascino@policlinicogemelli.it', 'phone': '+393388771472'}], 'overallOfficials': [{'name': 'Antonio Baldascino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Agostino Gemelli IRRCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}