Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT06009315

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

Led by Beijing Tiantan Hospital · Updated on 2024-08-01

949

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • NIHSS score of 4 or higher
  • Image-confirmed intracranial large artery occlusion (CTA/MRA/DSA)
  • ASPECT or PC-ASPECT score of 3 or higher
  • Undergoing endovascular treatment including arterial thrombolysis, mechanical thrombolysis, or angioplasty
  • Onset to puncture time less than 8 hours for anterior circulation or less than 12 hours for posterior circulation (exceptions allowed based on imaging assessment)
  • Signed informed consent by the patient or legal representative
Not Eligible

You will not qualify if you...

  • Pre-stroke modified Rankin Scale score greater than 2
  • History of intracranial bleeding disorders such as cerebral hemorrhage or subarachnoid hemorrhage
  • Coagulation disorders, history of systemic bleeding, thrombocytopenia, or neutropenia
  • Renal insufficiency with blood creatinine more than twice the upper limit of normal
  • Severe cardiopulmonary disease or life expectancy less than 3 months
  • Contraindications to DSA examination or severe contrast allergy
  • Women of childbearing age who refuse effective contraception, are pregnant, or breastfeeding
  • Psychiatric, cognitive, or mood disorders preventing study completion
  • Other investigator-determined reasons making participation unsuitable

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

R

Ruquan Han

CONTACT

F

Fa Liang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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