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Not yet recruiting NCT05576727

Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

— Observational Intracranial Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unruptured intracranial aneurysms.
Who it may be relevant to
Registry conditions: Intracranial Aneurysm. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Predictive value of coincidence of TWR and NWSS for unruptured aneurysm rupture [Time frame: at 5 year]
  • Predictive value of serum TNF-α for unruptured aneurysm rupture [Time frame: at 5 year]
  • Predictive value of sex for unruptured aneurysm rupture [Time frame: at 5 year]
Secondary outcome measures (3)
  • Predictive value of coincidence of TWR and NWSS for unruptured aneurysm growth [Time frame: at 5 year]
  • Predictive value of serum TNF-α for unruptured aneurysm growth [Time frame: at 5 year]
  • Predictive value of sex for unruptured aneurysm growth [Time frame: at 5 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT05576727 · UNruAneu

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗