PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- Clinical outcomes based on distribution of modified Rankin Scale score(mRS)
研究概览
简要总结
Investigators are conducting a real world, observational, prospective, multicenter study to better understand treatment for patients with MeVo and distal vessel occlusions in the U.S post publication of recent MeVO trials.
详细描述
The primary objective of this study is to better understand the change in landscape, post clinical trials publication, of the management of medium vessel occlusion (MeVO) causing acute ischemic strokes (AIS) in the first 24 hours. This study will help us better understand the "equipoise" in the eyes of practicing physicians across the U.S. Investigators will include patients with MevO treated with mechanical thrombectomy as well as patients treated medically.
Study design: This prospective, multicenter, observational study will include patients treated with best medical treatment (BMT) and patients who are treated endovascularly (endovascular treatment (EVT)). Patients who receive intra-arterial thrombolytics will also be included in the EVT group. In addition, patients who have received intravenous thrombolysis (tPA or tNK) will be included and patients who have not received any treatment.
Patients presenting with symptoms of AIS in the anterior circulation secondary to MeVO will be screened at every participating site for inclusion in this pragmatic, observational, prospective registry. The definition of MeVO for this study includes the M2-M3 segments of the MCA, A2-A3 segments of the anterior cerebral artery (ACA), and P1-P3 segments of the posterior cerebral artery (PCA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke clinically eligible for immediate EVT
- •Age ≥18 - 85 years of age
- •Time from onset (or last-seen-well) to 24 hours
- •Disabling stroke defined as follows:
- •A. Baseline National Institutes of Health Stroke Scale (NIHSS) score >5 B. Baseline NIHSS 3-5 with disabling deficit (e.g., hemianopia, aphasia, loss of hand function) as determined and agreed upon by two physicians in context of the patient's life
- •Confirmed treatable MeVO based on neurovascular non-invasive imaging (CTA or MRA), at one or more of the following locations: M2 or M3 segment, A2 or A3 segment, P1, P2 or P3 segment
- •Informed consent: Within the first 72 hours after inclusion in the study
排除标准
- •ASPECTS ≤ 5
- •Any intracranial hemorrhage on initial CT head non contrast
- •Known pregnancy (local protocol to determine if patient is pregnant at the time of stroke)
- •Known severe allergy (more than a rash) to contrast media uncontrolled by medications
- •CT evidence of the following conditions:
- •Midline shift or herniation
- •Mass effect with effacement of the ventricles
- •Acute bilateral strokes
- •Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
- •Intracranial tumors other than small meningioma that does not require surgery for one year post randomization.
- •Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
- •Baseline platelet count <80,000 per microliter (µl)
- •Life expectancy is less than one year prior to stroke onset
- •Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
- •15. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
研究组 & 干预措施
Endovascular Treatment
Intra-arterial Treatment
Medical Management
Intravenous Thrombolytic
结局指标
主要结局
Clinical outcomes based on distribution of modified Rankin Scale score(mRS)
时间窗: 3 months +/- 15 days
The modified Rankin Scale (a 7-point scoring system, 0 indicates no residual stroke symptoms and 6 represents death) is assessed through patient/caregiver interview by trained personnel.
次要结局
- Utility weighted Modified Rankin scale (mRS) at 90 days(3 months +/- 15 days)
- Excellent functional recovery (mRS 0-1)(3 months +/- 15 days)
- Functional independence (mRS 0-2)(3 months +/- 15 days)
研究者
Kaustubh Limaye
Associate Professor of Neurology, Neurological Surgery and Radiology
Indiana University