Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 4:49 PM
Study NCT ID:
NCT06817434
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2025-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009072', 'term': 'Moyamoya Disease'}], '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': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2025-01-26', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke)', 'timeFrame': '18 months during follow-up', 'description': 'The occurrence of cerebrovascular events, including TIA, ischemic stroke, or hemorrhagic stroke, will be assessed over an 18-month follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Changes in Neurological Function (mRS, NIHSS) at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': 'The mRS and NIHSS will be used to assess changes in neurological function at 12 and 18 months after treatment.'}, {'measure': 'Changes in Cognitive Function (MoCA, MMSE) at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': 'The MoCA and MMSE will be used to evaluate changes in cognitive function at 12 and 18 months after treatment.'}, {'measure': 'Structural Remodeling of the Internal Carotid Artery Terminal and Middle Cerebral Artery Wall at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': 'High-resolution magnetic resonance vessel wall imaging will be used to evaluate structural remodeling changes in the internal carotid artery terminal and middle cerebral artery wall at 12 and 18 months after treatment.'}, {'measure': 'Changes in Cerebral Blood Perfusion at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': 'ASL will be used to assess cerebral blood perfusion changes at 12 and 18 months after treatment.'}, {'measure': 'Rate of New Cerebral Infarcts at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': 'The occurrence of new cerebral infarcts at 12 and 18 Months after treatment will be evaluated using MRI.'}, {'measure': 'Hemodynamic Changes at the Internal Carotid Artery Terminal at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': '4D-Flow MRI and hemodynamic analysis will be used to evaluate changes in hemodynamics at the internal carotid artery terminal at 12 and 18 months after treatment.'}, {'measure': 'Changes in Blood Lipid Levels at 12 and 18 Months After Treatment', 'timeFrame': '12 and 18 months during follow-up', 'description': 'Blood lipid levels will be measured and compared at 12 and 18 months after treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moyamoya Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with MMD in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The imaging examination meets the diagnostic criteria for moyamoya disease;\n2. Sign the informed consent form;\n3. Age ≥18 years old;\n4. Baseline mRS score ≤2 points;\n5. The patient receives revascularization/conservative treatment;\n6. There is at least 1 imaging follow-up result.\n\nExclusion Criteria:\n\n1. Patients with atherosclerosis, autoimmune diseases, meningitis, Down syndrome, cranial trauma, or those who have undergone radioactive head irradiation, as these conditions may lead to secondary cerebrovascular disease and contribute to the development of Moyamoya syndrome;\n2. Individuals under the age of 18;\n3. Participants who refuse to take part in this study;\n4. Pregnant patients;\n5. Those with concurrent intracranial aneurysms, cerebrovascular malformations, brain tumors, or hydrocephalus;\n6. A history of stroke occurring more than three months prior to the diagnosis of Moyamoya disease;\n7. Individuals with a history of coronary heart disease or previous cardiovascular and cerebrovascular surgical interventions, including cerebral revascularization, intracranial artery stent implantation, carotid artery stenting, endarterectomy, coronary artery bypass grafting, or coronary stent implantation;\n8. Allergies to contrast media;\n9. Patients with missing imaging data or whose image quality cannot be analyzed;\n10. Individuals who refuse or are unable to undergo imaging follow-up;\n11. Patients receiving other types of lipid-lowering drug treatments.'}, 'identificationModule': {'nctId': 'NCT06817434', 'acronym': 'SEST-MOYA', 'briefTitle': 'Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease', 'orgStudyIdInfo': {'id': 'KY2023-297-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Revascularization/Conservative management', 'type': 'DRUG', 'description': 'Revascularization/Conservative management'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Zhang, MD', 'role': 'CONTACT', 'email': 'zhangqianchina@yahoo.com', 'phone': '8613120012579'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qian Zhang', 'role': 'CONTACT', 'email': 'zhangqianchina@yahoo.com', 'phone': '8613120012579'}, {'name': 'Chaofan Zeng', 'role': 'CONTACT', 'email': 'zchf723@163.com', 'phone': '8613693276138'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}