Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-29 @ 7:46 PM
Study NCT ID:
NCT04064658
Status:
SUSPENDED
Last Update Posted:
2019-09-19
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009072', 'term': 'Moyamoya Disease'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'whyStopped': 'waiting for the ethics approval of collaborator affiliation', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Cerebrovascular Events.', 'timeFrame': 'postoperative one month', 'description': 'Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.'}, {'measure': 'Number of Patients Dependent or Death', 'timeFrame': 'postoperative one month', 'description': 'Dependent included the modified Rankin Scale (mRS) \\> 2. Death included any reason caused death.'}], 'secondaryOutcomes': [{'measure': 'The Severity of the Ischemic Stroke after Surgery', 'timeFrame': 'postoperative one month', 'description': 'The severity of the ischemic stroke was evaluated by the white matter hyperintensities volume on the MRI, the neurological deficits duration and the Modified Rankin Scale (mRS) of patients.'}, {'measure': 'Number of Patients Occured Re-stroke at Follow-up Period', 'timeFrame': '6 months and 12 months after EDAS', 'description': 'Re-stroke included ischemic stroke and hemorrhagic stroke.'}, {'measure': 'Number of Patients Dependent or Death at Follow-up Period', 'timeFrame': '6 months and 12 months after EDAS', 'description': 'Dependent included the modified Rankin Scale (mRS) \\> 2. Death included any reason caused death.'}, {'measure': 'Number of Patients with Improved Neurological Function at Follow-up Period', 'timeFrame': '6 months and 12 months after EDAS', 'description': 'The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores'}, {'measure': 'Perfusion Status of Patients at Follow-up Period', 'timeFrame': '6 months and 12 months after EDAS', 'description': 'The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging'}, {'measure': 'Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.', 'timeFrame': 'From baseline to 12 months after treatment', 'description': 'The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and EDAS.'}, {'measure': 'Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.', 'timeFrame': 'Within 48 hours after EDAS', 'description': 'The presence of ≥1 new brain lesions on DWI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moyamoya Disease', 'Cerebrovascular Disorders', 'Arterial Occlusive Diseases', 'Ischemia'], 'conditions': ['Moyamoya Disease', 'Remote Ischemic Preconditioning']}, 'referencesModule': {'references': [{'pmid': '36645250', 'type': 'DERIVED', 'citation': 'Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.'}]}, 'descriptionModule': {'briefSummary': 'In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).', 'detailedDescription': 'BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.In order to investigate whether RIPC before EDAS can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.\n\nDESIGNING: About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to RIPC group and sham RIPC group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least five days before EDAS. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before EDAS. Cerebral injury is assessed by plasma Human Soluble protein-100B (S-100B) and Neuron specific enolase (NSE). Clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and transient neurological deficit) and death or dependent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who diagnosed with moyamoya disease\n2. Adults 18 to 65 years of age\n3. The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic)\n4. Able to receive the necessary imaging examination\n5. Patients who pre-agreed to the study\n\nExclusion Criteria:\n\n1. Prior cerebral hemorrhage history\n2. Other brain or cerebrovascular disease\n3. Previous history of revascularization surgery\n4. Dependent (mRS \\> 2)\n5. Receive other type of revascularization surgery\n6. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).\n7. Patients who do not agree with the study'}, 'identificationModule': {'nctId': 'NCT04064658', 'acronym': 'RIME', 'briefTitle': 'Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis', 'orgStudyIdInfo': {'id': 'RIPC2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham RIPC group', 'description': 'Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment.\n\nDevice:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in Sham RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis.\n\nProcedure: Encephaloduroarteriosynangiosis', 'interventionNames': ['Procedure: Sham remote ischemic preconditioning', 'Procedure: Encephaloduroarteriosynangiosis']}, {'type': 'EXPERIMENTAL', 'label': 'RIPC group', 'description': 'Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment.\n\nDevice:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis.\n\nProcedure: Encephaloduroarteriosynangiosis', 'interventionNames': ['Procedure: Remote ischemic preconditioning', 'Procedure: Encephaloduroarteriosynangiosis']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'PROCEDURE', 'otherNames': ['RIPC'], 'description': 'Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.', 'armGroupLabels': ['RIPC group']}, {'name': 'Sham remote ischemic preconditioning', 'type': 'PROCEDURE', 'otherNames': ['Sham RIPC'], 'description': 'Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.', 'armGroupLabels': ['Sham RIPC group']}, {'name': 'Encephaloduroarteriosynangiosis', 'type': 'PROCEDURE', 'otherNames': ['EDAS'], 'description': 'Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease', 'armGroupLabels': ['RIPC group', 'Sham RIPC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hosiptal', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University International Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yuanli Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}, {'name': 'Rong Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after the study ended', 'ipdSharing': 'YES', 'description': 'The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.', 'accessCriteria': 'The IPD of this study are available from the principal investigator upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University International Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'yuanli Zhao', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}