跳至主要内容
临床试验/NCT05708079
NCT05708079招募中不适用

Multidimensional Evaluation of Patients With Acute Ischemic Stroke Undergoing Pharmacological and Endovascular Revascularization Procedures for the Identification of Positive Prognostic Factors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
3 months mRS

研究概览

简要总结

In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Systemic and endovascular thrombolytic treatments in acute cerebral ischemic stroke caused by occlusion of large caliber vessels are currently the standard of care for the acute treatment of stroke.

The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life".

The study will have the characteristics of a descriptive observational study on patients suffering from acute ischemic stroke treated at the Policlinico A. Gemelli-IRCCS from 1 January 2016 to 31 December 2023. These data will be compared with a retrospective control group of patients undergoing mechanical thrombectomy for cerebral ischemic stroke in our polyclinic.

The primary endpoint is the outcome of patients treated with mechanical endovascular thrombectomy evaluated with the modified Ranking Scale at 90 days, while as secondary endpoints some individual characteristics of the patient will be considered (sex, age, clinical history, etc.), characteristics of the thrombus (anatomical-pathological, radiological etc) and related to acute management (therapy, rehabilitation, etc).

详细描述

Background and rationale of the study In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Recently, while some developments have been observed in the acute treatment of ischemic stroke such as the introduction of thrombolysis with rt-PA in the acute phase, in the face of acceptable side effects (NINDS, SITS MOST, ECASS), new treatments have been approved for the acute treatment of some types of acute stroke, such as endovascular treatment.

Endovascular treatment in acute cerebral ischemic stroke caused by large vessel occlusion has become the standard of care following the publication of five multicenter randomized trials performed in different reference centers in 2015. In these studies, the treatment cut-off was set at 4.5 hours, a previously validated standard time for intravenous thrombolysis, only for one of these was it instead set at 6 hours. In 2018, two other trials were published, which demonstrated the efficacy of the treatment even beyond 6 hours, one 16 hours after onset, the other up to 24 hours.

Several case studies have now been published which confirm the results of these latest trials, and others which demonstrate how the indications can be extended even beyond those envisaged by the most recent international guidelines.

The development of this therapeutic approach has therefore upset what was the standard therapy and consequently the natural history of many patients suffering from cerebral ischemic stroke.

The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life" (outside a randomized multicenter trial), as well as to define more precisely indications, contraindications , benefits (outcome at 90 days measured with the modified Ranking Scale) and possible complications of this technique. Furthermore, the presence of cofactors relating to acute management, thrombus characteristics and the data emerging from neuro-imaging performed in the acute phase that can determine better results will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • age > 18 years
  • Acute ischemic stroke with consistent neurologic and radiologic evidence.
  • Performing a CT without contrast and a triphasic CT angiography.
  • Execution of mechanical endovascular thrombectomy procedure (whose indication is placed by a neurologist and interventional neuroradiologist).

排除标准

  • patients lost to follow-up (e.g. back-transfer).

结局指标

主要结局

3 months mRS

时间窗: 3 months

outcome of patients treated by mechanical endovascular thrombectomy evaluated with modified Ranking Scale at 90 days.

次要结局

  • Radiological-clinical correlation(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Andrea, MD MSc

MD, MSc, Neuroradiologist

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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