Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06711302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-28', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of mRS (0-2)', 'timeFrame': '90±7 days', 'description': 'Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.'}], 'secondaryOutcomes': [{'measure': 'Proportion of mRS (0-1)', 'timeFrame': '90±7 days', 'description': 'Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.'}, {'measure': 'mRS Score as ordinal variable', 'timeFrame': '7±1 days', 'description': 'Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.'}, {'measure': 'mRS Score as ordinal variable', 'timeFrame': '30±7 days', 'description': 'Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.'}, {'measure': 'Cognitive function score as ordinal variable', 'timeFrame': '7±1 days', 'description': 'Montreal Cognitive Assessment, MoCA. The total score is 30, with higher scores indicating better cognitive function.'}, {'measure': 'The complete blood count', 'timeFrame': 'During hospitalization', 'description': 'up to 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage', 'Cerebrovascular Disorders', 'Brain Diseases', 'Stroke', 'Cardiovascular Diseases', 'Vascular Diseases', 'Nervous System Diseases']}, 'referencesModule': {'references': [{'pmid': '40789732', 'type': 'DERIVED', 'citation': 'Jin T, Niu H, Liu L, Yin Y, Zhao W, Feng X, Xu L, Hess DC, Liu A, Ji X. Remote ischaemic conditioning for efficacy in patients with aneurysmal subarachnoid haemorrhage (REPAIR): protocol for a multicentre, randomised, double-blind, sham-controlled, parallel-group trial. BMJ Open. 2025 Aug 11;15(8):e101350. doi: 10.1136/bmjopen-2025-101350.'}]}, 'descriptionModule': {'briefSummary': 'Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.\n\nRemote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.\n\nThe precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.\n\nBased on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of SAH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);\n2. The Hunt-Hess grade is 2-3 at admission;\n3. Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;\n4. The responsible aneurysm has been treated by endovascular interventional therapy;\n5. 18≤ age ≤80 years old;\n6. Informed consent must be obtained from participants or legally authorized representatives.\n\nExclusion Criteria:\n\n1. Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;\n2. Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;\n3. With severe comorbidities and a life expectancy of less than 90 days;\n4. Refractory hypertension (Systolic blood pressure\\> 180 mmHg or diastolic blood pressure \\>110 mmHg);\n5. Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;\n6. Concurrent participation in another protocol investigating a different experimental therapy;\n7. Any condition that the investigator believes may increase the patient's risk."}, 'identificationModule': {'nctId': 'NCT06711302', 'acronym': 'REPAIR', 'briefTitle': 'Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial', 'orgStudyIdInfo': {'id': 'HX-A-2024009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Guideline-based therapy+Sham RIC is given twice a day with 60mmHg pressure.', 'interventionNames': ['Device: Sham RIC']}, {'type': 'EXPERIMENTAL', 'label': 'RIC Group', 'description': 'Guideline-based therapy+RIC RIC is given twice a day with 200mmHg pressure.', 'interventionNames': ['Device: Remote Ischemic Conditioning treatment instrument']}], 'interventions': [{'name': 'Sham RIC', 'type': 'DEVICE', 'description': 'Remote Ischemic Conditioning is given twice a day with 60mmHg pressure.', 'armGroupLabels': ['Sham group']}, {'name': 'Remote Ischemic Conditioning treatment instrument', 'type': 'DEVICE', 'description': 'Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.', 'armGroupLabels': ['RIC Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Aihua Liu, Doctor', 'role': 'CONTACT', 'email': 'liuaihuadoctor@ccmu.edu.cn', 'phone': '+15901398688'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Aihua Liu, Doctor', 'role': 'CONTACT', 'email': 'liuaihuadoctor@ccmu.edu.cn', 'phone': '+8615901398688'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After publication of the main trial results, subject to legal and ethical approvals.', 'ipdSharing': 'YES', 'description': 'De-identified participant data and study materials will be accessible.', 'accessCriteria': 'Approved investigators will have access to deidentified data by contacting the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}