[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524488":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":26,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"Xinqiao Hospital of Chongqing","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypothermia","EXPERIMENTAL","Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.",[13,14],"Procedure: hypothermia","Procedure: thrombectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","ACTIVE_COMPARATOR","Patients in Control group received endovascular thrombectomy alone.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","hypothermia","In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"thrombectomy","Thrombectomy includes treatment with stent retrievers and\u002For thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Guangxiong Yuan, M.S.","CONTACT","18973223018","yuanguangxiong74@163.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zhongming Qiu","Professor",[42],{"name":43,"class":6},"Xiangtan Central Hospital","100524488","role-of-hypothermia-in-endovascular-stroke-thrombectomy-100524488",false,"NCT06109376","Role of Hypothermia in Endovascular Stroke Thrombectomy","Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial","COOLING","Inclusion Criteria:\n\n1. Aged ≥ 18 years or more;\n2. acute ischemic stroke within 24 hours from onset to randomization;\n3. NIHSS ≥6 points before randomization;\n4. Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA\u002FMRA\u002FDSA;\n5. Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume \\\u003C 100ml;\n6. The patient decides to undergo endovascular therapy;\n7. The patient or patient's representative signs a written informed consent form.\n\nExclusion Criteria:\n\n1. CT or MR evidence of hemorrhage;\n2. Currently pregnant or lactating (women patients);\n3. Allergy to radiographic contrast agents, or nitinol devices;\n4. Arterial tortuosity and\u002For other arterial disease that would prevent the device from reaching the target vessel;\n5. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);\n6. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;\n7. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;\n8. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;\n9. Intracranial aneurysm, arteriovenous malformation;\n10. Any terminal illness with life expectancy less than 6 months;\n11. Participating in other clinical trials.","ALL","18 Years",{"count":55,"type":56},200,"ESTIMATED","INTERVENTIONAL",[59],"NA","Reducing or suspending the increase of the infarcted core, i.e., \"freezing\" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.\n\nIn recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.\n\nThe objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.",[62],"Stroke, Acute Ischemic",[64,23,65,66],"endovascular thrombectomy","large vessel occlusion","randomized controlled trial","NOT_YET_RECRUITING","2023-10-25",{"date":70,"type":71},"2023-10-31","ACTUAL",{"date":73,"type":56},"2023-12-01",{"date":75,"type":56},"2027-03-31",{"name":5,"class":6}]