NCT06778226已完成不适用
ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,827
- 试验地点
- 3
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The purpose of TRIMIS is to study how a medical procedure by the name of endovascular therapy compares to medical treatment alone in patients with mild stroke and a blood vessel occlusion in the brain
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Acute ischemic stroke in an adult patient (18 years of age or older).
- •Onset (Last Seen Normal) time to treatment time <24 hours or unknown Last Seen Normal in whom Endovascular Therapy could be considered per local radiographic guidelines.
- •Mild stroke defined as an NIH Stroke Scale ≤ 5 at the time of treatment decision.
- •a. Patients with NIH Stroke Scale=0 can be included in the study if they have relevant abnormalities on neurological exam.
- •An acute intracranial vessel occlusion (Intracranial Internal Carotid Artery terminus (T or L clot), Middle Cerebral Artery (M1, M2, M3/beyond), Anterior Cerebral Artery (A1, A2, A3), V4, Basilar, Posterior Cerebral Artery) defined by non-invasive acute imaging (Computed Tomography, angiography (Computed Tomography Angiography) or Magnetic Resonance angiography (MRA)) that is neurologically relevant to the presenting symptoms and signs.
排除标准
- •Stroke symptoms due to another non-ischemic acute neurological condition such as seizure with Post-ictal Todd's paralysis or focal neurological signs due to severe hypo- or hyperglycemia.
- •Hyperdensity on Non-contrast Computed Tomography consistent with intracranial hemorrhage. Any clinical suspicion of any intracranial hemorrhage even in the absence of visible blood on baseline brain imaging.
- •Large acute stroke >1/3 Middle Cerebral Artery territory or Alberta Stroke Programme Early CT score (ASPECTS<6 or established frank hypodensity relevant to the presenting acute stroke already visible on baseline CT scan.
- •Findings on acute CT or MRI to suggest that the
- •Patient has a severe or fatal or disabling illness that will impact decision regarding acute reperfusion therapies.
- •Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
- •Stroke occurred as an inpatient.
- •Inclusion into any randomized control trials.
研究组 & 干预措施
Delayed Endovascular Therapy
Data previously collected from medical records of participants will be analyzed with the purpose of studying the efficiency of Delayed Endovascular Therapy. Length of the cohort is 6 years.
Medical Management
Data previously collected from medical records of participants will be analyzed with the purpose of studying the efficiency of Medical Management. Length of the cohort is 6 years.
Immediate Endovascular Therapy
Data previously collected from medical records will be analyzed with the purpose of studying the efficiency of Immediate Endovascular Therapy. Length of the cohort is 6 years.
结局指标
主要结局
Modified Rankin Scale
时间窗: 90 Days
Scores range from 0-6. (0 = normal, 6 = dead).
次要结局
- Symptomatic Intracerebral Hemorrhage (sICH)(48 hours)
- Change in National Institute of Health Stroke Scale (NIHSS)(24 hours, 7 days)
- Modified Rankin Scale(7 days)
研究者
Negar Asdaghi
Associate Professor of Neurology
University of Miami
研究点 (3)
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