Endovascular Therapy for Low NIHSS Ischemic Strokes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 143
- 试验地点
- 68
- 主要终点
- Symptomatic intracranial hemorrhage (sICH) within 36 hours comparing the two treatment arms
研究概览
简要总结
This study will test the hypothesis that patients presenting within 8 hours of onset with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).
详细描述
Currently, the vast majority of these patients do not receive immediate vessel imaging with either CT- or MR-angiography. However, acute ischemic stroke patients with low NIHSS who harbor a large vessel occlusion (LVO) later decline in 20-40% of cases, and/or have underappreciated impairments related to their relatively mild strokes. Similarly, LVO patients presenting with a transient ischemic attack (TIA) are under increased risk of clinical deterioration. Such patients with apparent good collateral circulation, and hence a substantial perfusion of the vascular territory of the occluded large artery, likely have the most to gain from endovascular revascularization. At the same time, this collateral perfusion may allow for more frequent recanalization, either spontaneously or by intravenous (IV) rtPA. Experience with immediate mechanical thrombectomy (iMT) in the LVO mild stroke target population is limited.
This study will test the hypothesis that patients presenting within 8 hours of onset with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18 years or older
- •Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of an objective neurological deficit
- •Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.5 hours from symptom onset
- •Proximal Intracranial Artery Occlusion on Imaging by NCCT/CTA or MRI/MRA showing complete occlusion of the intracranial ICA, M1, or an "M1-like" M2 vessel with or without tandem cervical lesion. Notably, "M1-like" M2 vessel occlusions are defined functionally for the trial as following:
- •On CTA: Occlusion of both branches after MCA division (both M2s occluded) or occlusion of the larger diameter M2 branch . In case of trifurcations, either the two largest M2 branches are occluded or the occluded M2 has a larger diameter than the combined diameter of the two other M2s . Notably, the M2 origins are defined by the first branching point in the MCA other than the anterior temporal artery rather than by anatomic landmarks (e.g., horizontal versus insular location).
- •If mCTA or CTP performed (optional): a M2 occlusion which supplies a large proportion of the MCA territory by evidence of either:
- •i. The bulk (>2/3) of the MCA territory has evidence of delayed washout on multiphase CT or ii. Perfusion imaging shows a hypoperfusion lesion volume involving a significant proportion of the MCA territory defined as Tmax >4 sec lesion of ≥100 mL
- •Baseline Infarct Core of either:
- •Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or
- •Baseline Infarct Core Volume of < 70cc on either CTP (Volume of rCBF <30%) or DWI if quantitative software tools are available (neither test is mandatory for study)
排除标准
- •Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH)
- •Any imaging findings suggestive of futile recanalization in the judgment of the local investigator
- •High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD
- •Premorbid disability (mRS ≥3)
- •Inability to randomize within 8 hours of last known well
- •Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- •Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol)
- •Known coagulation disorders as defined as platelet count <100,000/uL
- •Known renal failure as defined as serum creatinine levels > 3.0 mg/dL
- •Presumed septic embolus or suspicion of bacterial endocarditis
- •Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
- •Participation in another investigational treatment study in the previous 30 days
- •Intubation and mechanical ventilation prior to study enrollment is medically indicated
- •History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- •Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management)
- •Known pregnancy
- •Prisoner or incarceration
- •Known acute symptomatic COVID-19 infection
结局指标
主要结局
Symptomatic intracranial hemorrhage (sICH) within 36 hours comparing the two treatment arms
时间窗: 36 hours
Symptomatic intracranial hemorrhage (sICH) within 36 hours post treatment imaging scan, using SITS-MOST criteria, consisting of the presence of parenchymal hematoma type 2 (PH2) on neuroimaging associated with 4-point decline in NIHSS from baseline to 24 hours
Symptomatic intracerebral hemorrhage within 96 hours comparing the two treatment arms
时间窗: 96 hours
Symptomatic intracerebral hemorrhage is defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage within 96 hours post-randomization, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 hour, or leading to death
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis).
时间窗: 90-day
The distribution of the modified Rankin Scale (mRS) is assessed by structured assessment. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
次要结局
- Number of patients with excellent outcome comparing the two treatment arms arms(90-day)
- Self-reported mental and physical health PROMIS Global-10 score(90-day)
- Shift in distribution of the 90-day mRS with levels 5-6 combined (0;1;2;3;4;5-6) comparing the two treatment arms(90-day)
- Health-related quality of life EQ-5D score comparing the two treatment arms(90-day)
- Infarct volume(24 hours post randomization)
- Mortality rate within 90 days comparing the two treatment arms(90-day)
- Number of patients with good outcome comparing the two treatment arms(90-day)
- Number of patients with early Neurologic Deterioration (END) comparing the two treatment arms(24 hours post randomization)
- Self-reported PROMIS Fatigue score(90-day)
- Number of patients with intracranial hemorrhages using the Heidelberg Bleeding definition comparing the two treatment arms(90-day)
- Instrumental Activities of Daily Living (IADL)(90-day)
研究者
Raul Gomes Nogueira
Professor
Emory University