Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-02 @ 11:46 AM
Study NCT ID:
NCT07049692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Hyperbaric Oxygen Combined With Endovascular Treatment in Patients With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 424}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale (mRS) scores [(0, normal)-(6, worst)]', 'timeFrame': 'Day 90 (±7) post-randomization', 'description': 'mRS is defined as the gold standard for measuring global functional outcomes after stroke: 0-1 indicating functional independence, 0-2 favorable prognosis, defining functional independence, 4-5 Severely disabled, 6 death. Higher mRS scores indicate worse prognosis.'}], 'secondaryOutcomes': [{'measure': 'Core infarction volume on Diffusion-Weighted Imaging', 'timeFrame': 'Day 10 (±2）post-randomization', 'description': 'The effectiveness of HBO for patients with acute ischemic stroke was evaluated based on the core cerebral infarction volume.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)]', 'timeFrame': 'Day 10(±2) NIHSS score post-randomization', 'description': 'The effectiveness of HBO therapy in patients with acute ischemic stroke undergoing endovascular treatment was evaluated based on the improvement rate of NIHSS score day 10 post-randomization.'}, {'measure': 'mRS score [ (0, Normal)-(6, worst)]', 'timeFrame': 'Day 10 (±2）post-randomization; Day 30(±5) post-randomization; Day 180(±14) post-randomization; Day 360(±30d) post-randomization.', 'description': 'To assess the effectiveness of HBO treament for ischemic stroke using mRS score on day 10, 30, 90 and 360 post-randomization'}, {'measure': 'Distribution of mRS score [(0, normal)-6(worst)]', 'timeFrame': 'Day 90 (±7) post-randomization', 'description': 'mRS (0-1): the proportion of functional independence; mRS (0-2): the proportion of good prognosis; mRS (4-6) : the proportion of severe disability.'}, {'measure': 'Bartherl index (BI)[(0, worst)-(100, normal)]', 'timeFrame': 'Day 30(±5), 90(±7) , 180(±14) and 360 (±30) post-randomization', 'description': 'Functional independence was assessed using the BI'}, {'measure': 'EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)]', 'timeFrame': 'Day 30(±5), 90(±7), 180(±14), 360(±30) post-randomization', 'description': 'Health-related quality of life was measured using EQ-5D.'}, {'measure': 'Stroke recurrence rate', 'timeFrame': 'Day 30(±5) , 90(±7d), 180(±14d) and 360(±30) post-randomization', 'description': 'New symptoms persisting for \\> 24 hours and new lension on the DWI.'}, {'measure': 'Cardiovascular events', 'timeFrame': '30(±5), 90(±7), 180(±14), 360(±30) post-randomization', 'description': 'arrhythmia, acute coronary syndrome, and sudden cardiac death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HBO', 'acute ischemic stroke', 'endovascular treatment'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '1. The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO) combined with endovascular treatment in patients with acute ischemic stroke.\n2. The main questions it aims to answer is:\n\n Whether HBO combined with endovascular treatment can improve the prognosis of ischemic stroke?\n3. Participants will :\n\nreceive HBO or high-flow oxygen treatment, administered once daily for 10 consecutive sessions.\n\nundergo three scheduled telephone follow-up assessments during the 12-month period following HBO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years\n* Patients presenting clinical manifestations of acute anterior circulation ischemic stroke (6-20 NIHSS points) who underwent endovascular thrombectomy\n* Consciousness status (NIHSS 1a-1b items): 0-1 points\n* Pre-stroke functional status (mRS score): 0-1\n* Time from onset to randomization ≤ 2 weeks\n* Patient or legal representative who signed the informed consent form\n* Preoperative CT angiography or magnetic resonance angiography confirmed large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that was consistent with the symptoms and signs\n* A lberta S troke P rogram E arly C T S core ≥ 6\n\nExclusion Criteria:\n\n* Subjects with HBO contraindications or intolerance\n* Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation\n* Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis\n* Expected lifespan \\< 90 days\n* Severe heart, liver and kidneys failure\n* Pregnancy\n* Hereditary or acquired bleeding tendency, deficiency of coagulation factors, recent use of oral anticoagulants with an international normalized ratio (INR) \\> 3 or activated partial thromboplastin time (APTT) exceeding the normal value by more than 3 times\n* Baseline platelet count \\< 50×10 9/L\n* Baseline blood glucose is less than 2.78 mmol/L or greater than 22.2 mmol/L.\n* Unstable vital signs (heart rate ≤ 50 beats/min or ≥ 120 beats/min, oxygen saturation ≤ 90%, respiration ≥ 30 breaths/min or ≤ 10 breaths/min);\n* Hypertension that cannot be controlled by medication: Systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;\n* Suspected of having acute myocardial infarction;\n* Currently involving in the research of other projects related to drugs or medical devices.\n* CT or MRI scans revealed intracranial tumors (except for cerebellar meningiomas) and intracranial arteriovenous malformations.\n* Based on the medical history and CT or MRI findings, a diagnosis of internal carotid artery dissection or aortic dissection is suspected;\n* Based on the medical history and CT or MRI findings, cerebral vasculitis is suspected.\n* Based on the clinical evidence of multiple vascular regions being occluded (either in the bilateral anterior circulation or anterior/posterior circulation) or bilateral infarction or multi-region infarction as detected by CT angiography or magnetic resonance angiography;\n* CT or magnetic resonance imaging shows a significant midline shift effect (\\> 0.5 cm);\n* CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;'}, 'identificationModule': {'nctId': 'NCT07049692', 'acronym': 'NOTICE-1', 'briefTitle': 'Evaluation of the Efficacy and Safety of Hyperbaric Oxygen Combined With Endovascular Treatment in Patients With Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Hyperbaric Oxygen Combined With Endovascular Treatment in Patients With Acute Ischemic Stroke: A Multicenter, Open-label, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2025-KE-357'}, 'secondaryIdInfos': [{'id': '2025-3-4-2', 'type': 'REGISTRY', 'domain': 'NOTICE-1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperbaric oxygen therapy', 'interventionNames': ['Other: Hyperbaric Oxygen Therapy']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: High-flow oxygen therapy']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy', 'type': 'OTHER', 'description': '1.6 atmosphere absolute (1.6 ATA), HBO treatment administrated via mask or hood, one 60 minutes session, once daily, 10 sessions per course, inter-session intervals of fewer than 48 hours.', 'armGroupLabels': ['hyperbaric oxygen therapy']}, {'name': 'High-flow oxygen therapy', 'type': 'OTHER', 'description': '1 atmosphere absolute (1 ATA), high-flow oxygen delieved at 10L/min (100%) via mask or hood, one 60 minutes session, once daily, 10 sessions per course, inter-session intervals of fewer than 48 hours.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Guangxu Liu', 'role': 'CONTACT', 'email': 'bjcyh_yjxbf@163.com', 'phone': '+86 010-85231129'}], 'facility': 'Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shuyuan Yuan', 'role': 'CONTACT', 'email': 'shuhua_yuan@126.com', 'phone': '+86 18511703665'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '31/12/2028-31/12/2043', 'ipdSharing': 'YES', 'description': '1. Primary/secondary efficacy endpoint data\n2. Safety data\n3. Baseline characteristic dataset\n4. Plan Deviation Record', 'accessCriteria': 'Qualified researchers can access de-identified IPD, protocols, and analysis plans through \\[Repository Name\\] after submitting a research proposal and signing a Data Use Agreement. Data is available in CDISC formats for non-commercial research only, with results required within 24 months. Re-identification and commercial use are prohibited.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hyperbaric Oxygen Department', 'investigatorFullName': 'Jing Yang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}