Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:49 AM
Study NCT ID:
NCT07309718
Status:
RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MPR for Stroke Risk Assessment of ICAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial 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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.', 'timeFrame': '12 months', 'description': 'the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.'}], 'secondaryOutcomes': [{'measure': 'transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year', 'timeFrame': '12 months', 'description': 'the number of participants who suffer from transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year after enrollment.'}, {'measure': 'TIA related to ischemia in the qualifying artery territory within 1 year', 'timeFrame': '12 months', 'description': 'the number of participants who suffer from TIA related to ischemia in the qualifying artery territory within 1 year'}, {'measure': 'any stroke/TIA/ death within 1 year', 'timeFrame': '12 months', 'description': 'the number of participants who suffer from any stroke/TIA/ death within 1 year'}, {'measure': 'hemodynamic ischemic stroke in the qualifying artery territory within 1 year', 'timeFrame': '12 months', 'description': 'the number of participants who suffer from hemodynamic ischemic stroke in the qualifying artery territory within 1 year'}, {'measure': 'embolic stroke within in the qualifying artery territory 1 year', 'timeFrame': '12 months', 'description': 'the number of participants who suffer from embolic stroke within in the qualifying artery territory 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICAS - Intracranial Atherosclerosis', 'Stroke Ischemic', 'Hemodynamic', 'Pressure ratio'], 'conditions': ['ICAS - Intracranial Atherosclerosis', 'Stroke Ischemic', 'Hemodynamic']}, 'descriptionModule': {'briefSummary': 'Intracranial atherosclerotic stenosis (ICAS) carries substantial stroke risk despite optimal medical treatment. Current risk stratification relies primarily on stenosis severity, but novel hemodynamic markers may improve prediction. In this multiple prospective registry study we aim to investigate whether regional hemodynamics, measured by a novel Magnetic resonance imaging-derived Pressure Ratio (MPR) technique, are associated with stroke risk in ICAS.', 'detailedDescription': 'This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 5 participating stroke centres , and plans to recruit 400 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, 1 month, 6 months, and 12 months post-enrollment. All participants received standardized medical therapy, including dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines. Multimodal imaging techniques were employed to assess hemodynamic status: luminal stenosis would be evaluated using transcranial Doppler (TCD), computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA), high-resolution MRI and phase-contrast MR angiography (PC-MRA) would be collected to calculate MPR. The primary outcomes were ischemic stroke in the qualifying artery territory or related death within 1 year. There were 5 secondary outcomes, including hemodynamic ischemic stroke in the qualifying artery territory within1 year. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ICAS involving 50% to 99% stenosis of a major intracranial artery in the anterior circulation, including the internal carotid artery (ICA C6-C7 segment) and the middle cerebral artery M1 (MCA-M1) segment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 to 80 years.\n2. Intracranial atherosclerotic stenosis ICAS involving a culprit artery in the anterior circulation.\n3. Intracranial arterial stenosis of 50% to 99% as measured by the WASID method using TCD, CTA, MRA, or DSA.\n4. Written informed consent obtained from the participant or a legal representative.\n\nExclusion Criteria:\n\n1. Non-atherosclerotic intracranial lesions, including moyamoya disease, vasculitis, vascular dissection, autoimmune diseases, or congenital/genetic abnormalities.\n2. More than 50% stenosis of the extracranial carotid artery on the ipsilateral side.\n3. Large cerebral infarction involving more than one-half of the territory on DWI imaging, or a baseline modified Rankin Scale score ≥3.\n4. Contraindications to antiplatelet therapy or statins.\n5. Inability to undergo MRI due to metal implants or claustrophobia.'}, 'identificationModule': {'nctId': 'NCT07309718', 'briefTitle': 'MPR for Stroke Risk Assessment of ICAS', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'MRI-Derived Pressure Ratio: a Novel Noninvasive Hemodynamic Biomarker for Stroke Risk Stratification in Intracranial Atherosclerotic Stenosis', 'orgStudyIdInfo': {'id': 'CASSISS-MPR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CASSISS-MPR', 'interventionNames': ['Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention']}], 'interventions': [{'name': 'Standardized medical therapy targeting vascular risk factors and stroke prevention', 'type': 'DRUG', 'description': 'Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines', 'armGroupLabels': ['CASSISS-MPR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Xicheng District', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jichang Luo, M.D.', 'role': 'CONTACT', 'email': 'luojichang_dr@sina.com', 'phone': '+86 13120136577'}], 'facility': 'Department of Neurosurgery, Xuanwu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jichang Luo, M.D.', 'role': 'CONTACT', 'email': 'luojichang_dr@sina.com', 'phone': '+86 13120136577'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xuanwu Hebei Hospital', 'class': 'UNKNOWN'}, {'name': 'Xuanwu Xiongan Hospital', 'class': 'UNKNOWN'}, {'name': 'Xuanwu Chifeng Hospital', 'class': 'UNKNOWN'}, {'name': 'Xuanwu Jinan Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}