Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03216369
Status:
UNKNOWN
Last Update Posted:
2017-07-13
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic Event', 'timeFrame': 'Up to 1 year', 'description': 'The patients will be monitored whether they recured ischemic event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.'}], 'secondaryOutcomes': [{'measure': 'Hyperperfusion Syndrome', 'timeFrame': '3 months', 'description': 'The patients will be monitored whether they experienced hyperperfusion syndrome.'}]}, 'conditionsModule': {'keywords': ['Arterial Spin Labeling', 'MRI', 'Perfusion', 'Carotid artery stenting', 'Carotid endarterectomy'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Carotid artery stenting(CAS) and endarterectomy(CEA) are both important treatment strategy for patients with ICA (internal carotid artery) stenosis. Three dimensional pseudo-continuous arterial spin labeling (pCASL) is a noninvasive perfusion imaging modality to detect reperfusion for recanalization therapy. And it provides information about absolute CBF (ml 100 g-1 tissue min-1) at the brain tissue level. The aim of the present study was to evaluate the series hemodynamic changes in patients who had conducted CAS or CEA by using 3D pseudo-continuous arterial spin labeling (pCASL) to explore the potential pattern of CBF alternation and thus to improve the prevention strategy for hyperperfusion syndrome.', 'detailedDescription': 'Patients:\n\nPatients with unilateral severe internal carotid artery (ICA) stenosis of stroke eligible were enrolled who underwent CAS vs CEA.All patients underwent previous scan in 7 days before CAS and CEA and consecutive scan once per 24 hours after CAS and CEA.\n\nBaseline characteristics of patients were recorded including age,gender, hypertension, hypercholesterolemia, diabetes melitus, smoking, obesity, qualifying stroke event.\n\nProtocols:\n\nMRI scan protocols T2 weighted image,T1 weighted image,diffusion weighted image(DWI),fluid-attenuated inversion recovery (FLAIR),arterial spin labeling(ASL) with Post labeling delay (PLD) of 2.0s,Territory ASL(TASL)(PLD=2.0s),3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).\n\nImaging evaluation：\n\n1. Pseudo-continuous arterial spin labeling (pCASL) with post labeling delay (PLD) of 2.0s evaluation of cerebral blood flow in target downstream territory.\n2. FLAIR hyperintensity vascular sign.\n3. Collateral pattern assessment by Territorial ASL(TASL) (PLD=2.0s).\n\nTreatment strategy:\n\nPatients were randomly treated by CEA(carotid endarterectomy) or CAS(carotid artery stenting).\n\nFollow up:\n\nPatients were followed up every 24 hours after treatment procedure, and would have a repeat MRI scan after 3 months, 6 months and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Symtomatic patients with unilateral severe internal carotid artery (ICA) stenosis.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* informed patient's consent for ICA stenting or endarterectomy\n* lack of contraindications to MRI\n* Symptomatic, unilateral ICA stenosis 70-99%;irrelevant stenosis \\<50% of contralateral ICA\n* TIA or stroke - within 360 days\n\nExclusion Criteria:\n\n* Intracranial hemorrhage\n* Informed consent not obtained\n* Common exclusion for MRI such as patients with claustrophobia\n* Patients with poor imaging quality（Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis）\n* Bilateral internal carotid artery occlusion"}, 'identificationModule': {'nctId': 'NCT03216369', 'briefTitle': 'Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Short- and Long-Term Hemodynamic Effects Revealed by Arterial Spin Labeling MRI of Carotid Endarterectomy and Carotid Artery Stenting', 'orgStudyIdInfo': {'id': 'CEA/CAS-Radiology-ChinaPLAGH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'carotid artery stenting and carotid endarterectomy', 'description': 'Symptomatic patients with unilateral ICA severe stenosis by magnetic resonance angiography were performed 3D pseudo-Continuous Arterial Spin Labeling MRI before and after CAS and CEA.', 'interventionNames': ['Other: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'MRI perfusion imaging', 'armGroupLabels': ['carotid artery stenting and carotid endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinhao Lyu, BS', 'role': 'CONTACT', 'email': 'lvjinhao@hotmail.com', 'phone': '+8613391851857'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yina Lan, M.D.', 'role': 'CONTACT', 'email': '729992938@qq.com', 'phone': '+86 17326826301'}, {'name': 'Jinhao Lyu, M.D.', 'role': 'CONTACT', 'email': 'lvjinhao@hotmail.com'}], 'overallOfficials': [{'name': 'Xin Lou, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief', 'investigatorFullName': 'Xin Lou', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}