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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Other: Unruptured intracranial aneurysms

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Gao Chen; Phone Number: +86 0571 87784813; Email: d-chengao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310029
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The enrolled patients are who have unruptured asymptomatic aneurysm with a clinical, a biological and an imaging follow-up, without any relative treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unruptured Intracranial Aneurysm	Other: Unruptured intracranial aneurysms; Extensive clinical, biological and imaging data of unruptured intracranial aneurysm patients will be recorded during a 5 years follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Predictive value of serum TNF-α for unruptured aneurysm rupture	at 5 years, the value of the factor (serum TNF-α) to predict aneurysm rupture risk will be analyzed	at 5 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Predictive value of serum TNF-α for unruptured aneurysm growth	at 5 years, the value of the factor (serum TNF-α) to predict aneurysm growth risk will be analyzed	at 5 year
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; The Central Hospital of Lishui City; First Affiliated Hospital of Wenzhou Medical University; Jinhua Central Hospital; Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Intracranial Arterial Diseases; Rupture; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: UNruAneu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No