Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

NCT05576727 | Not Yet Recruiting

• 1 other identifier: UNruAneu
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Predictive value of coincidence of TWR and NWSS for unruptured aneurysm growth

  at 5 year

• Predictive value of serum TNF-α for unruptured aneurysm growth

  at 5 year

• Predictive value of sex for unruptured aneurysm growth

  at 5 year

Study Arms (1)

Unruptured Intracranial Aneurysm

Other: Unruptured intracranial aneurysms

Interventions

Unruptured intracranial aneurysms OTHER

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

Unruptured Intracranial Aneurysm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310029, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gao Chen

CONTACT

+86 0571 87784813; d-chengao@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 12, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

CN (1)