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临床试验/NCT04357899
NCT04357899已完成不适用

Stroke Research Consortium in Northern Bavaria - STAMINA, a Multicenter Longitudinal Cohort Study on Ischemic Stroke Treatment

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 3,769 人开始时间: 2006年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,769
试验地点
2
主要终点
Favorable Outcome (modified Rankin Scale 0-1)

研究概览

简要总结

Each year, approximately 15 million people suffer a stroke worldwide of which 80% are due to ischemic cerebral infarction. Based on the results of randomized controlled trials, treatment options and patient outcomes in acute ischemic stroke have dramatically improved in recent years. However, these advances in thrombolysis and endovascular therapy need to be established outside controlled trials to optimize stroke management, treatment procedures, patient selection and inter-hospital transfer in clinical practice. This multicenter longitudinal cohort study is based on a large stroke care network in Northern Bavaria, Germany (region of more than 3.5 million inhabitants) to evaluate and improve treatment in ischemic stroke.

详细描述

Methods: This multicenter longitudinal cohort study will include ischemic stroke patients treated within a telemedical stroke care network and patients transferred to tertiary stroke centers for treatment procedures from hospitals outside the telemedical network. Individual patient data are available from two tertiary stroke centers and 24 primary and secondary stroke facilities in Northern Bavaria, Germany. Patients with ischemic stroke transferred to the tertiary stroke centers for treatment procedures - i.e. endovascular therapy or thrombolysis in stroke with an unknown time of onset - and all stroke patients with either large vessel occlusion (LVO) and/or thrombolysis therapy admitted to the University Hospital Erlangen will be integrated from institutional prospective stroke registries. Consecutive patients admitted between January 2006 and December 2019 will be included, an estimated total number of more than 3000 ischemic stroke patients - approximately 1000 patients with LVO receiving endovascular therapy, 1000 patients with LVO not receiving endovascular therapy and 1000 patients without LVO receiving thrombolysis therapy.

Demographic and clinical data including medical history, medication and laboratory results will be obtained by review of medical charts, institutional databases or prospective registries, supplemented by structured interviews on follow-up information or by review of all available medical records. In detail the following parameters will be evaluated: prior medical history (e.g. comorbidities, premorbid functional status, medication), admission status (e.g. NIHSS, GCS, body temperature, arterial blood pressure), cerebral imaging parameters (e.g. Alberta Stroke Program Early CT score [ASPECTS], perfusion volumes, mismatch and collateral status on admission imaging, final infarct volume on follow-up imaging), treatment procedures (e.g. intravenous thrombolysis, endovascular therapy, decompressive surgery), time intervals (e.g. symptom onset or last seen normal until admission, imaging, thrombolysis, groin puncture, recanalization), complications (e.g. hemorrhagic transformation, arterial dissection, distant ischemic stroke), laboratory parameters, clinical and diagnostic follow-up (e.g. neurological status, blood pressure, vascular ultrasound), stroke etiology, secondary prevention (e.g. lipid lowering medication, antiplatelet therapy, anticoagulation) and clinical outcomes (e.g. mortality, modified Rankin Scale).

Ethics Approval: The study was approved by the Institutional Review Board of the Friedrich-Alexander-Universität Erlangen-Nürnberg.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
  • Presence of large vessel occlusion (as evidenced by CTA, MRA or DSA) and/or intravenous thrombolysis therapy applied

排除标准

  • Age < 18 years

结局指标

主要结局

Favorable Outcome (modified Rankin Scale 0-1)

时间窗: at day 90

Proportion of participants with favorable outcome (mRS 0-1)

Infarct volume

时间窗: at day 5 (±2)

Infarct volume on CT or diffusion-weighted MRI

Lesion growth volume

时间窗: at day 5 (±2)

Lesion growth volume between ischemic core on baseline imaging and infarkt volume

Functional Outcome (modified Rankin Scale 0-6)

时间窗: at day 90

The Distribution of Scores on the modified Rankin Scale (mRS)

Functional Independence (modified Rankin Scale 0-2)

时间窗: at day 90

Proportion of participants with functional independence (mRS 0-2)

Intracranial hemorrhage

时间窗: at 24 (±6) hours

Rate of intracranial hemorrhage defined according to different criteria (ECASS II, SITS-MOST, NINDS or Parenchymal hemorrhage Type 2) on the 24 hour scan

Recanalization Rates

时间窗: at 24 (±6) hours

Recanalization of the primary arterial occlusive lesion (based on ultrasound, clinical and radiological assessment) at 24-hours

次要结局

  • Mortality(at 90 days)
  • Procedure time(procedure)
  • Door-to-groin puncture time(until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first)
  • Door-to-needle time(until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first)
  • Symptom-to-door time(until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first)
  • Interhospital transfer time(until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (2)

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