Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)

Last updated: July 30, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Thrombosis

Blood Clots

Treatment

N/A

Clinical Study ID

NCT06009315
LF20230819
  • Ages 18-100
  • All Genders

Study 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

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, andangioplasty (onset to puncture time is recommended to be less than 8 hours foranterior circulation and less than 12 hours for posterior circulation; thoseexceeding the time window will be determined by the neurointerventionalist throughimaging assessment);

  • Signed informed consent by the patient or legal representative

Exclusion

Exclusion Criteria:

  • Pre-stroke mRS score >2;

  • Intracranial bleeding disorders: cerebral hemorrhage, subarachnoid hemorrhage, etc.;

  • presence of coagulation disorders, history of systemic bleeding, history ofthrombocytopenia or neutropenia;

  • Renal insufficiency with elevated blood creatinine (greater than 2 times the upperlimit 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 ofless than 3 months or otherwise unable to complete this study;

  • Contraindication to DSA examination, severe contrast allergy or absolutecontraindication to iodine contrast; women of childbearing age who have a negativepregnancy test but refuse to use effective contraception, are pregnant or breastfeeding;

  • Those who are unable to complete the study due to psychiatric disorders, cognitiveor mood disorders;

  • Other patients who, in the opinion of the investigator, are not suitable forenrollment in the study (specify reason).

Study Design

Total Participants: 949
Study Start date:
February 23, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100070
    China

    Active - Recruiting

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