Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation for Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
Overview
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.
Primary outcome measures
- Functional independence at 90 days [Time frame: 90±7days after treatment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tiantan Hospital, Capital Medical University — Beijing
Publications
- Wang X, Liang F, Wu Y, Jia B, Wang A, Zhang X, Zhang K, Hou X, Jian M, Wang Y, Liu H, Miao Z, Han R. Development and Validation of a Two-step Model to Predict Outcomes After Endovascular Treatment for Patients With Acute Ischemic Stroke. J Neurosurg Anesthesiol. 2025 Jul 1;37(3):305-312. doi: 10.1097/ANA.0000000000001008. Epub 2024 Sep 18. PMID 39291867
Identifiers
NCT: NCT06009315 · LF20230819