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NCT Number: NCT05576727

Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310029, China

Location contact

Gao Chen

CONTACT

About this study

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.

Who can participate

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

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.

Treatment and study plan

Unruptured intracranial aneurysms

Other

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

Primary outcomes

  1. Predictive value of coincidence of TWR and NWSS for unruptured aneurysm rupture

    Time frame: at 5 year

    at 5 years, the value of the factor (coincidence of TWR and NWSS) to predict aneurysm rupture risk will be analyzed

  2. Predictive value of serum TNF-α for unruptured aneurysm rupture

    Time frame: at 5 year

    at 5 years, the value of the factor (serum TNF-α) to predict aneurysm rupture risk will be analyzed

  3. Predictive value of sex for unruptured aneurysm rupture

    Time frame: at 5 year

    at 5 years, the value of the factor (sex) to predict aneurysm rupture risk will be analyzed

Secondary outcomes

  1. Predictive value of coincidence of TWR and NWSS for unruptured aneurysm growth

    Time frame: at 5 year

    at 5 years, the value of the factor (coincidence of TWR and NWSS) to predict aneurysm growth risk will be analyzed

  2. Predictive value of serum TNF-α for unruptured aneurysm growth

    Time frame: at 5 year

    at 5 years, the value of the factor (serum TNF-α) to predict aneurysm growth risk will be analyzed

  3. Predictive value of sex for unruptured aneurysm growth

    Time frame: at 5 year

    at 5 years, the value of the factor (sex) to predict aneurysm growth risk will be analyzed

Study contacts

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • Jinhua Central Hospital
  • Ningbo Medical Center Lihuili Hospital
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • The Central Hospital of Lishui City

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 12, 2022
Registry last updated
Oct 13, 2022

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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