Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

Intracranial Aneurysm Clinical Trial

Official title:

Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05576727
• Other study ID #: UNruAneu
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Gao Chen
• Phone: +86 0571 87784813
• Email: d-chengao[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of aneurysm by digital subtraction angiography (DSA);

2. Age between 18-70 years old;

3. Informed consent form for this study was signed

Exclusion Criteria:

1. Dissecting aneurysms and saccular aneurysms with other vascular diseases such as arteriovenous malformations, moyamoya disease, and arteriovenous fistulas were excluded;

2. Combined with serious systemic diseases;

3. 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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Rupture

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of coincidence of TWR and NWSS for unruptured aneurysm rupture	at 5 years, the value of the factor (coincidence of TWR and NWSS) to predict aneurysm rupture risk will be analyzed	at 5 year
Primary	Predictive value of serum TNF-a for unruptured aneurysm rupture	at 5 years, the value of the factor (serum TNF-a) to predict aneurysm rupture risk will be analyzed	at 5 year
Primary	Predictive value of sex for unruptured aneurysm rupture	at 5 years, the value of the factor (sex) to predict aneurysm rupture risk will be analyzed	at 5 year
Secondary	Predictive value of coincidence of TWR and NWSS for unruptured aneurysm growth	at 5 years, the value of the factor (coincidence of TWR and NWSS) to predict aneurysm growth risk will be analyzed	at 5 year
Secondary	Predictive value of serum TNF-a for unruptured aneurysm growth	at 5 years, the value of the factor (serum TNF-a) to predict aneurysm growth risk will be analyzed	at 5 year
Secondary	Predictive value of sex for unruptured aneurysm growth	at 5 years, the value of the factor (sex) to predict aneurysm growth risk will be analyzed	at 5 year