Intra-Arterial Administration of Neuroprotective Agents and Cold Saline at Time of Recanalization for Acute Ischemic Stroke Due to Large Vessel Occlusion
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Intracranial hemorrhage
研究概览
简要总结
Ischemic stroke is the leading cause of long-term disability in the United States. Endovascular intervention with mechanical thrombectomy has become the standard of care for acute large vessel occlusion (LVO) stroke since multiple clinical trials demonstrated improved long-term clinical outcomes with treatment. However, despite high rates of successful vessel recanalization and thus reperfusion of ischemic brain tissue in current practice, many patients continue to suffer debilitating strokes and poor long-term functional outcome. Pharmacologic neuroprotection could potentially present a means of addressing this mismatch in radiologic vs. clinical outcomes by protecting and salvaging damaged brain tissue. Intra-arterial delivery of a cocktail of neuroprotective therapy at the time of endovascular reperfusion would provide immediate, targeted therapy directly to the damaged brain territory. Hypothermia, minocycline and magnesium can target multiple facets of the complex ischemic injury cascade, and have each demonstrated neuroprotection in multiple preclinical models. This is a phase I trial that aims to demonstrate safety and feasibility of administering cold saline, minocycline, and magnesium sulfate intra-arterially immediately after thrombectomy in stroke interventions.
详细描述
This is a phase I, single center, single arm clinical trial with dose escalation design.
Location: North Shore University Hospital in Manhasset, NY
Study population: Subjects aged 18-90 years undergoing mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion at North Shore University Hospital
Primary Objective: To demonstrate the safety and feasibility of intra-arterial administration of a cocktail of neuroprotective agents at the time of reperfusion in endovascular stroke intervention for acute ischemic stroke due to large vessel occlusion.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-90
- •Signed and dated informed consent and IRB form by the patient or legally authorized health care proxy.
- •Diagnosis of acute ischemic stroke due to large vessel occlusion based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at Northshore University Hospital.
- •Participants must meet criteria for intra-arterial thrombectomy as determined and documented by the Stroke Neurology and Interventional Neuroradiology attending physicians at Northshore University Hospital.
- •Angiography must reveal a thromboembolism which is completely occluding flow within the intracranial portion of the internal carotid artery, the M1 or proximal M2 portions of the middle cerebral artery.
排除标准
- •Patients that do not otherwise meet criteria for endovascular intervention
- •Large vessel occlusion of the anterior cerebral artery, posterior circulation, or distal M2 portion of the middle cerebral artery.
- •Recanalization of only TICI 0-2A.
- •Pregnant or lactating women.
- •Therapeutic anticoagulation prior to presentation.
- •Known allergic reactions to contrast dye or components of minocycline (tetracycline) or magnesium sulfate.
- •Patients with a known prior diagnosis of heart block or prior myocardial infarction (increased risk of adverse reaction to MgSO4).
- •Renal insufficiency (creatinine > 2.5 mg/dL)
- •Severe hepatic functional impairment (AST > 10xULN, bilirubin > 5xULN)
- •Systemic lupus erythematosus
- •Idiopathic intracranial hypertension
研究组 & 干预措施
Intra-arterial neuroprotective substances
Cold saline, minocycline, and magnesium sulfate to be infused intra-arterially immediately after thrombectomy via the internal carotid artery. A dose escalation design will be used, as described above in "Study Description."
干预措施: Intra-arterial cold saline, minocycline, and magnesium (Drug)
结局指标
主要结局
Intracranial hemorrhage
时间窗: within 24 hours of treatment
Presence of symptomatic intracranial hemorrhage
Presence of serious adverse event
时间窗: within 72 hours of treatment
Related to intra-arterial administration of cold saline, minocycline, or magnesium sulfate
次要结局
- Functional outcome(90 days after intervention)
- Infarct volume(24 hours after procedure)
