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Идёт набор NCT06009315

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

— Наблюдательное Acute Ischemic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Ischemic Stroke. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Первичные конечные точки

  • Functional independence at 90 days [Срок оценки: 90±7days after treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital, Capital Medical University — Пекин

Публикации

  • 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

Идентификаторы

NCT: NCT06009315 · LF20230819

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗