Clinical trial NCT06009315: Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
Official title: Development and Validation for Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke,
Anesthesia
Predictive Model
Endovascular therapy
Deep learning
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 949
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke caused by large undergoing endovascular therapy

Brief summary: 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.


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).

Primary outcomes:
measure: Functional independence at 90 days
timeFrame: 90±7days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: