Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

NCT ID: NCT05576727

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Unruptured Intracranial Aneurysm

Unruptured intracranial aneurysms

Intervention Type OTHER

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

Interventions

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Unruptured intracranial aneurysms

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Gao Chen

Role: CONTACT

+86 0571 87784813

Facility Contacts

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Gao Chen

Role: primary

Other Identifiers

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UNruAneu

Identifier Type: -

Identifier Source: org_study_id

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