跳至主要内容
临床试验/NCT06009315
NCT06009315招募中不适用

Development and Validation for Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 949 人开始时间: 2024年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
949
试验地点
1
主要终点
Functional independence at 90 days

研究概览

简要总结

Stroke is the leading cause of disability-adjusted life years (DALYs) in China, imposing a heavy burden on society and families. Endovascular therapy (EVT) has opened the 2.0 era of acute ischemic stroke (AIS) treatment, but still up to 1/3 of patients have poor neurological prognosis. The results of several studies at home and abroad and by our team indicate that anesthesia method and perioperative management are one of the key factors affecting the neurological prognosis of EVT treatment in AIS patients. Based on machine learning big data analysis methods, a prognostic model for EVT treatment of AIS patients can be established to guide individualized treatment decisions. Current prediction models only include patients' baseline variables, and lack the inclusion of intraoperative (anesthesia management and interventional process) and postoperative (intensive monitoring treatment) variables, which limits the clinical application of prediction tools. We will establish a large prospective cohort database including preoperative, intraoperative, and postoperative variables, integrate heterogeneous information from multiple sources based on artificial intelligence machine learning algorithms, and build prognostic prediction models with better clinical applicability and calibration, with the aim of optimizing perioperative management of endovascular therapy, guiding individualized clinical decision-making, and improving patients' clinical prognosis.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years;
  • NIHSS score ≥4;
  • Image-confirmed (CTA/MRA/DSA) intracranial large artery occlusion;
  • ASPECT (anterior circulation) or PC-ASPECT (posterior circulation) score ≥3;
  • Endovascular treatment including arterial thrombolysis, mechanical thrombolysis, and angioplasty (onset to puncture time is recommended to be less than 8 hours for anterior circulation and less than 12 hours for posterior circulation; those exceeding the time window will be determined by the neurointerventionalist through imaging assessment);
  • Signed informed consent by the patient or legal representative

排除标准

  • Pre-stroke mRS score >2;
  • Intracranial bleeding disorders: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
  • presence of coagulation disorders, history of systemic bleeding, history of thrombocytopenia or neutropenia;
  • Renal insufficiency with elevated blood creatinine (greater than 2 times the upper limit of normal);
  • Presence of severe cardiopulmonary disease that, in the opinion of the investigator, makes participation in this study unsuitable; patients with a life expectancy of less than 3 months or otherwise unable to complete this study;
  • Contraindication to DSA examination, severe contrast allergy or absolute contraindication to iodine contrast; women of childbearing age who have a negative pregnancy test but refuse to use effective contraception, are pregnant or breast feeding;
  • Those who are unable to complete the study due to psychiatric disorders, cognitive or mood disorders;
  • Other patients who, in the opinion of the investigator, are not suitable for enrollment in the study (specify reason).

结局指标

主要结局

Functional independence at 90 days

时间窗: 90±7days after treatment

modified Rankin Scale of 0-2

次要结局

未报告次要终点

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

Professor & Director

Beijing Tiantan Hospital

研究点 (1)

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