Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
Study NCT ID:
NCT06801457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-30
First Post:
2025-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious adverse events/Adverse events', 'timeFrame': 'Through study completion', 'description': 'total number of serious adverse events/adverse events reported during follow-up, according to standard definitions'}, {'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': 'Up to 36 hours after randomization', 'description': 'Number of cases of symptomatic intracerebral hemorrhage according to standard definition'}, {'measure': 'Any intracranial hemorrhage', 'timeFrame': 'Up to 36 hours after randomization', 'description': 'Number of cases of any intracranial hemorrhage according to standard definitions'}, {'measure': 'Early neurological deterioration', 'timeFrame': '24 hours after randomization', 'description': 'Early neurological deterioration at 24 hours, defined as at least 4-point increase in National Institutes of Health Stroke Scale (NIHSS) score from baseline; Larger the increase means worsening of outcomes. The Increase of score range from 0 to 42.'}, {'measure': 'Heart rate at the end of oxygen therapy', 'timeFrame': 'Day 0', 'description': 'Vital signs at the end of oxygen therapy'}, {'measure': 'Respiratory rate at the end of oxygen therapy', 'timeFrame': 'Day 0', 'description': 'Vital signs at the end of oxygen therapy'}, {'measure': 'Systolic blood pressure at the end of oxygen therapy', 'timeFrame': 'Day 0', 'description': 'Vital signs at the end of oxygen therapy'}, {'measure': 'Diastolic blood pressure at the end of oxygen therapy', 'timeFrame': 'Day 0', 'description': 'Vital signs at the end of oxygen therapy'}, {'measure': 'Oxygen saturation at the end of oxygen therapy', 'timeFrame': 'Day 0', 'description': 'Vital signs at the end of oxygen therapy'}], 'primaryOutcomes': [{'measure': 'Level of disability at 90 days measured by modified Rankin scale (mRS) score', 'timeFrame': '90 days after randomization', 'description': 'The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome; the primary outcome here is 3-month ordinal mRS score with mRS 5 and 6 merged into one category; modified intention-to-treat analysis'}], 'secondaryOutcomes': [{'measure': 'Functional independence at 90 days defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up', 'timeFrame': '90 days after randomization', 'description': 'The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome. The mRS score is dichotomized to define the functional independence as mRS score of 0-2.'}, {'measure': 'Excellent functional outcome at 90 days, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up', 'timeFrame': '90 days after randomization', 'description': 'The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome. The mRS score is dichotomized to define the excellent functional outcome as mRS score of 0-1.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) obtained obtained upon Endovascular Thrombectomy (EVT) site arrival', 'timeFrame': 'Day 0', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42 points, with higher scores indicating worse neurological deficits. This is obtained upon Endovascular Thrombectomy (EVT) site arrival.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) obtained at 24 hours', 'timeFrame': '24 hours after randomization', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42 points, with higher scores indicating worse neurological deficits.'}, {'measure': 'ASPECTS on admission head CT', 'timeFrame': 'Day 0', 'description': 'Alberta Stroke Program Early CT (ASPECT) score ranges from 0 to 10, with 10 being normal and 0 indicating complete MCA infarction obtained upon Endovascular Thrombectomy (EVT) site arrival.'}, {'measure': 'NCCT infarct volume at 24 hours in patients undergoing thrombolysis or EVT (standard of care)', 'timeFrame': '24 hours after randomization', 'description': 'Infarct volume measured by NCCT'}, {'measure': 'Proportion of patients with elevated troponin level upon EVT hospital arrival', 'timeFrame': 'Day 0', 'description': '0-100%. This measure is obtained upon Endovascular Thrombectomy (EVT) site arrival.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic stroke'], 'conditions': ['Stroke Acute']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.', 'detailedDescription': "Stroke is a leading cause of death and disability globally, with acute ischemic stroke (AIS) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. However, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 days, remains under 50%.\n\nNormobaric hyperoxia (NBO) emerges as a compelling option for cerebral protection. Its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. NBO's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. Its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 80 years old;\n* Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);\n* No prior stroke;\n* The time from stroke onset/last seen well to randomization is within 6 hours;\n* Paramedic-obtained FAST-ED score \\>= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);\n* No significant pre-stroke disability (pre-stroke mRS 0-1);\n* Signed informed consent from the patient or the legally authorized representative (LAR).\n\nExclusion Criteria:\n\n* Endotracheal intubation in the field (prior to consent);\n* Respiratory rate \\<= 10 or \\>= 30 breaths per minute;\n* Oxygen-dependence at baseline to maintain SaO2 \\> 95%;\n* Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;\n* Seizure at stroke onset;\n* Exhibiting symptoms of vomiting, severe headache, or unconscious;\n* Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.\n* Participating in another clinical trial, or completed participation within prior 30 days;\n* Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);\n* Life expectancy \\< 90 days due to comorbidities;\n* Unlikely to complete the 90-day follow-up visit."}, 'identificationModule': {'nctId': 'NCT06801457', 'acronym': 'AN-O2-EMS', 'briefTitle': 'Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke', 'orgStudyIdInfo': {'id': 'AN-O2-EMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBO', 'description': 'NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice.', 'interventionNames': ['Other: NBO']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Best medical treatment', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'NBO', 'type': 'OTHER', 'description': 'NBO will be conducted with inhalation of 100% oxygen.', 'armGroupLabels': ['NBO']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Best medical care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Wenbo Hu, MD', 'role': 'CONTACT', 'email': 'huwenbo0050@163.com', 'phone': '010-83911991'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lan Liu, PhD', 'role': 'CONTACT', 'email': 'liulan1815@outlook.com', 'phone': '8683911991'}, {'name': 'Wenbo Hu, MD', 'role': 'CONTACT', 'email': 'huwenbo0050@163.com', 'phone': '8683911991'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}