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NCT Number: NCT06009315

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-59976660

Ruquan Han, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Functional independence at 90 days

    Time frame: 90±7days after treatment

    modified Rankin Scale of 0-2

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: AURORA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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