Меню
Набор скоро начнётся NCT05576727

Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

— Наблюдательное Intracranial Aneurysm

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
В протоколе указаны: Unruptured intracranial aneurysms.
Кому может быть актуально
Состояния в реестре: Intracranial Aneurysm. Базовые параметры: 18 лет — 70 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

In recent years, researches on the natural history and risk factors of intracranial unruptured aneurysms have become a hot topic at home and abroad. However, risk factors for aneurysm rupture is still unclear yet. The investigators' preliminary study focused on constructing a rupture risk prediction system for intracranial unruptured aneurysm in the investigators' single center. The investigators' result showed that three significant factors (sex, abnormal serum tumor necrosis factor (TNF)-α and coincidence of thin-walled regions (TWR) and normalized wall shear stress (NWSS)) stood out by using logistic regression to explore the rupture risk factors of intracranial unruptured aneurysms, which could help guide the clinical treatment of intracranial unruptured aneurysms. This study is to evaluate and improve the rupture predict model of intracranial unruptured aneurysm in multi-neurosurgical centers.

Подробное описание

In recent years, researches on the natural history and risk factors of intracranial unruptured aneurysms have become a hot topic at home and abroad. However, risk factors for aneurysm rupture is still unclear yet. The investigators' preliminary study focused on constructing a rupture risk prediction system for intracranial unruptured aneurysm in the investigators' single center. Four aspects for unruptured aneurysms were collected: (1) Patients' basic demographic characteristics; (2) Reconstruction of intracranial unruptured aneurysm wall with 7-Tesla MRI, and explore the technical parameters of 7-Tesla high-resolution black blood MRI scanning intracranial aneurysm wall (0.5 mm isotropic resolution), as well as assessing the relationship between aneurysm wall enhancement (AWE), thin-walled regions (TWR), and hemodynamic parameters and their relationship to aneurysm development; (3) Using hydrodynamics to explore the hemodynamic parameters of intracranial unruptured aneurysms, explore new hydrodynamic parameters and screen rupture-related risk factors; (4) The use of single-cell RNA sequencing technology to explore the infiltration of immune cells in the aneurysm wall tissue of intracranial unruptured aneurysms. Based on the above research results, three significant factors (sex, abnormal serum TNF-α and coincidence of TWR and normalized wall shear stress (NWSS)) stood out by using logistic regression to explore the rupture risk factors of intracranial unruptured aneurysms, which could help guide the clinical treatment of intracranial unruptured aneurysms. This study is to evaluate and improve the rupture predict model of intracranial unruptured aneurysm in multi-neurosurgical centers.

Вмешательства

  • Другое Unruptured intracranial aneurysms
    Extensive clinical, biological and imaging data of unruptured intracranial aneurysm patients will be recorded during a 5 years follow-up.

Первичные конечные точки

  • Predictive value of coincidence of TWR and NWSS for unruptured aneurysm rupture [Срок оценки: at 5 year]
  • Predictive value of serum TNF-α for unruptured aneurysm rupture [Срок оценки: at 5 year]
  • Predictive value of sex for unruptured aneurysm rupture [Срок оценки: at 5 year]
Вторичные конечные точки (3)
  • Predictive value of coincidence of TWR and NWSS for unruptured aneurysm growth [Срок оценки: at 5 year]
  • Predictive value of serum TNF-α for unruptured aneurysm growth [Срок оценки: at 5 year]
  • Predictive value of sex for unruptured aneurysm growth [Срок оценки: at 5 year]

Критерии участия

Критерии включения

  • Diagnosis of aneurysm by digital subtraction angiography (DSA);
  • Age between 18-70 years old;
  • Informed consent form for this study was signed

Критерии исключения

  • Dissecting aneurysms and saccular aneurysms with other vascular diseases such as arteriovenous malformations, moyamoya disease, and arteriovenous fistulas were excluded;
  • Combined with serious systemic diseases;
  • Patients who cannot receive MRI/magnetic resonance angiography (MRA) examinations due to severely impaired renal function, allergy, space claustrophobia or internal implants in the body.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT05576727 · UNruAneu

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗