Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05623293
Status:
UNKNOWN
Last Update Posted:
2022-11-21
First Post:
2021-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2021-08-15', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke', 'timeFrame': '30 days', 'description': 'diagnosed by Computer tomography and clinical examation'}, {'measure': 'optical coherence tomography - Angio', 'timeFrame': '15 days before surgery', 'description': 'Vessel density and distribution'}, {'measure': 'optical coherence tomography - Angio', 'timeFrame': '24h after surgery', 'description': 'Vessel density and distribution'}, {'measure': 'optical coherence tomography - Angio', 'timeFrame': '30 days after surgery', 'description': 'Vessel density and distribution'}, {'measure': 'optical coherence tomography - Angio', 'timeFrame': 'one year after surgery', 'description': 'Vessel density and distribution'}], 'secondaryOutcomes': [{'measure': 'Restenosis', 'timeFrame': '2 months', 'description': 'ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carotid endarterectomy', 'Optimal coherence tomography,'], 'conditions': ['Choroid Disease', 'Carotid Stenosis', 'Carotid Atherosclerosis', 'Retinal Disease']}, 'referencesModule': {'references': [{'pmid': '26886118', 'type': 'BACKGROUND', 'citation': 'Nakazawa T. Ocular Blood Flow and Influencing Factors for Glaucoma. Asia Pac J Ophthalmol (Phila). 2016 Jan-Feb;5(1):38-44. doi: 10.1097/APO.0000000000000183.'}]}, 'descriptionModule': {'briefSummary': "The retinal vessels have been shown to reflect vascular changes inherent to systemic pathologies, even when no ocular disease is identified. As such, the eye's vasculature is ableto serve as a window to the vascular health of the human body and a means of assessing systemic endothelial function. Optical coherence tomography angiography (OCTA) employs optical means to image all the retinal vascular layers and the choroid, providing an extremely detailed image of the microvascular network in a fast, reproducible and totally non-invasive way. As such, it is currently the best non-invasive way of having an image of human capillaries. Recently, OCTA has been used to study the retinal vessels' structure and function in several cardiovascular diseases. As an example of its predictive potential, reduced retinal microvascular density has been associated with the cardiovascular risk profile in patients admitted to the hospital for an acute coronary syndrome. Recent studies have also shown the retinal microvasculature density to be reduced in patients with carotid artery disease (CAD), namely carotid stenosis, and that endarterectomy increases retinal flow and vessel density.", 'detailedDescription': 'The authors hypothesize that FGF-23, GDF-15, VEGF-A, MMP-9 and retinal/choroidal microvascular density could predict cerebral ischemia, postoperative complications, long term major cardiovascular events and short term ophthalmologic alterations particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.\n\nThe purpose of this study is to compare different cardiac risk scores in carotid endarterectomy. The main aim of this study is to test the risk factors individually and determine its discriminatory ability. Combinations of traditional preoperative risk factors and scores will be evaluated to enhance the assessment of major adverse cardiac events in vascular surgery patients.\n\nEstablish and validate biomarkers that improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a non-interventional prospective cohort study. The population corresponds to patients submitted to elective CEA. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia will be prospectively recruited from September 2021 - December 2022. The expected patient follow-up will be of w year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive carotid stenosis\n\nExclusion Criteria:\n\n* blind patients\n* Radic stenosis'}, 'identificationModule': {'nctId': 'NCT05623293', 'briefTitle': 'Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study', 'orgStudyIdInfo': {'id': '163-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carotid endarterectomy', 'description': 'he population corresponds to patients submitted to elective CEA. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia will be prospectively recruited from September 2021 - December 2022. The expected patient follow-up will be of 2years.', 'interventionNames': ['Diagnostic Test: eye - Optcial coherence tomography']}], 'interventions': [{'name': 'eye - Optcial coherence tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'pre and postoperative', 'armGroupLabels': ['Carotid endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-319', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Joao Rocha-Neves', 'role': 'CONTACT', 'email': 'joaorochaneves@hotmail.com', 'phone': '910486230'}], 'facility': 'Joao Rocha-Neves', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Joao Rocha-Neves, MD, MPH', 'role': 'CONTACT', 'email': 'joaorochaneves@hotmail.com', 'phone': '+351910486230'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Sao Joao', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'João Rocha Neves', 'investigatorAffiliation': 'Universidade do Porto'}}}}