Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-27 @ 5:42 AM
Study NCT ID:
NCT06545734
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in Peripheral circulating immune cells counts', 'timeFrame': '1, 3 and 5 days after procedure', 'description': 'Immune cell counts acquired from CBC.'}, {'measure': 'Difference in lymphocyte phenotyping', 'timeFrame': 'PBMC isolated from peripheral venous blood at 24 hours', 'description': 'CD4 T cells, CD8 T cells, B cells, NK cells count by flow cytometry.'}, {'measure': 'Difference in expression of genes associated with T cell polarization', 'timeFrame': 'PBMC isolated from peripheral venous blood at 24 hours', 'description': 'TBX21, GATA3, RORC and FOXP3'}, {'measure': 'Difference in cytokines and chemokines associated with T cell polarization and recruitment', 'timeFrame': 'Serum isolated from peripheral venous blood at 24 hours', 'description': 'IL-1β, IL-18, IL-17, IL-10, IFN-γ, TNF-α, IL-6, CX3CL1, CXCL10, CCL17'}], 'primaryOutcomes': [{'measure': 'Final Infarct volume', 'timeFrame': '24(-6/+12) hours after procedure', 'description': 'Infarct volume at 24 (-6/+12) hours postoperatively'}, {'measure': 'Infarct Volume Growth', 'timeFrame': '24(-6/+12) hours after procedure', 'description': 'Infarct volume at 24 (-6/+12) hours - Infarct volume at baseline; Infarct volume at 24 (-6/+12) hours - Infarct volume at 2 hours'}], 'secondaryOutcomes': [{'measure': 'Change in NIHSS between baseline and 2 hours', 'timeFrame': '2 hours after procedure', 'description': 'NIHSS at 2 hours - NIHSS at baseline'}, {'measure': 'Change in NIHSS between baseline and 24 hours', 'timeFrame': '24 hours after procedure', 'description': 'NIHSS at 24 hours - NIHSS at baseline'}, {'measure': 'Functional Independence at 90 days', 'timeFrame': '90 days after randomization', 'description': 'The proportion of mRS 0-2 at 90 days'}, {'measure': 'Functional Independence at 5 days or discharge', 'timeFrame': '5 days or at discharge after randomization', 'description': 'The proportion of mRS 0-2 at 5 days or discharge'}, {'measure': 'Blood brain barrier permeability at 72 hours', 'timeFrame': '72 hours after procedure', 'description': 'This is quantified by ktrans value through MR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke, Acute; Large Vessel Occlusion; Neuroprotection'], 'conditions': ['Stroke, Acute', 'Neuroprotection', 'Ischemic Conditioning']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC.\n\nThe primary questions this trial seeks to answer are:\n\n1. Is direct IPostC effective for acute stroke patients with large vessel occlusion?\n2. What are the underlying mechanisms of direct IPostC?\n\nParticipants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ischemic stroke confirmed by CT or MRI.\n2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).\n\n4\\. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.\n\n5\\. The patient or legally authorized representative has signed an informed consent form.\n\nExclusion Criteria:\n\n1. Inability to perform an MRI or CT scan for any reason.\n2. Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.\n3. Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.\n4. Pregnancy.\n5. Presence of other serious, advanced, or terminal illnesses.'}, 'identificationModule': {'nctId': 'NCT06545734', 'briefTitle': 'Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Huanhu Hospital'}, 'officialTitle': 'Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'TJHH-2024-WM28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endovascular therapy', 'interventionNames': ['Procedure: Endovascular therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Endovascular therapy plus direct ischemic post-conditioning', 'interventionNames': ['Procedure: Direct Ischemic Post-conditioning', 'Procedure: Endovascular therapy']}], 'interventions': [{'name': 'Direct Ischemic Post-conditioning', 'type': 'PROCEDURE', 'description': 'After thrombectomy, the balloon was inflated to a pressure of no more than 4 atm at the occlusion site to block blood flow for 2 minutes, as confirmed by angiography. The balloon was then deflated, allowing blood flow to resume for 2 minutes. These steps were repeated four times.', 'armGroupLabels': ['Endovascular therapy plus direct ischemic post-conditioning']}, {'name': 'Endovascular therapy', 'type': 'PROCEDURE', 'description': 'Thrombectomy alone.', 'armGroupLabels': ['Endovascular therapy', 'Endovascular therapy plus direct ischemic post-conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300070', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Wei, MD, PhD', 'role': 'CONTACT', 'email': 'drweiming@163.com', 'phone': '13502182903'}, {'name': 'Ming Wei, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Ming Wei, MD, PhD', 'role': 'CONTACT', 'email': 'drweiming@163.com', 'phone': '13502182903'}, {'name': 'Yongbo Xu, MD', 'role': 'CONTACT', 'email': 'yonbur@outlook.com', 'phone': '17361616533'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ming Wei', 'investigatorAffiliation': 'Tianjin Huanhu Hospital'}}}}