Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Blood glucose levels at the time of reperfusion
研究概览
简要总结
Postictus hyperglycemia is associated with an accelerated transformation of the ischemic penumbra into an infarct area, with increased infarct size, worse recanalization, reduced cerebral perfusion, increased ischemia reperfusion damage, and worse outcome. Furthermore, when perfusion is reinstated, hyperglycemia causes secondary tissue damage through an increase in ischemic reperfusion damage. Thus, those patients with glycemia values < 155 mg/dL during mechanical thrombectomy, and especially at the time of reperfusion, will have greater ischemia-reperfusion damage, showing a different profile in miRNA expression, with better neurological and functional outcomes and higher risk of hemorrhagic transformation and cerebral edema.
The main objective of the study is to evaluate the association between glycemia values at the time of reperfusion and stroke recovery at 3 months in patients with acute cerebral infarction treated with mechanical thrombectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years of age
- •Neuroimaging studies such as computed tomography (CT), angio-CT or angio-MRI compatible with the diagnosis of acute cerebral infarction due to occlusion of a large vessel of the anterior circulation, including the internal carotid artery (intra- or extracranial) or middle cerebral artery (M1 or M2 segments).
- •Indication of mechanical thrombectomy according to clinical practice.
- •Inclusion of the patient in the study before the endovascular procedure.
- •Modified Rankin Scale (mRS) score prior to stroke of 0-
- •Signature of informed consent.
排除标准
- •CT, angio-CT or angio-MRI showing posterior circulation occlusion.
- •Severe or life-threatening concomitant disease that precludes follow-up for 3 months after stroke,
- •Alcohol or drug abuse
- •Participation in a therapeutic clinical trial.
研究组 & 干预措施
Subcutaneous blood glucose monitoring device
After signing the informed consent and before the start of the endovascular procedure, a subcutaneous blood glucose monitoring device will be implanted, which will be removed on day 15 (or at hospital discharge if this takes place before 15 days).
干预措施: Subcutaneous blood glucose monitoring device (Device)
结局指标
主要结局
Blood glucose levels at the time of reperfusion
时间窗: During reperfusion procedure
Blood glucose levels at the time of reperfusion in patients achieving TICI-2b, TICI-2c or TICI3 recanalization pattern after mechanical thrombectomy.
Modified Rankin scale at 3 months
时间窗: From baseline to month 3
Its dichotomized assessment (Modified Rankin Scale or mRS 0-2 indicating good functional recovery and 3-6 indicating death or dependence) is commonly used in acute stroke studies.
次要结局
- Blood glucose values above 155 mg/dL(The entire time from arrival at the emergency room until completion of the arterial recanalization procedure.)
- Proportion of patients receiving insulin treatment(During the first 24 hours from the onset of stroke symptoms)
- Dose of insulin treatment received by clinical practice(Through study completion, an average of 2 years)
- Number of mechanical thrombectomy passes(Through study completion, an average of 2 years)
- Additional data of the subcutaneous blood glucose monitoring device(During the time the device is worn, up to 15 days)
- Infarct size(At 24 hours)
- Peak blood glucose values(During the mechanical thrombectomy procedure)
- Number of subcutaneous blood glucose monitoring devices with technical failures(Through study completion, an average of 2 years)
- Time in range 110-154 mg/dL of blood glucose values(From arrival at the emergency department to recanalization, during the first 24 hours and during hospital stay)
- Degree of recanalization(Through study completion, an average of 2 years)
- Arterial blood pressure(During reperfusion procedure)
- Hemorrhagic transformation(At 24 hours)
- National Institutes of Healt Stroke Scale score(At 24 hours and at 3 months)
- Mortality(At 3 months)
- Number of symptomatic hemorrhagic transformation(During a symptomatic hemorrhagic transformation)
- Neurological or systemic complications(During follow-up period, up to 3 months)
- Distribution of scores on the modified Rankin scale(At 90 days)
- Presence of biomarkers of ischemia-reperfusion injury(During reperfusion procedure and 24 hours later)