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Not yet recruitingNCT05576727Updated Oct 13, 2022

Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

An observational study in Intracranial Aneurysm, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Intracranial Aneurysm
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In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Unruptured Intracranial Aneurysm

    Other: Unruptured intracranial aneurysms

Interventions

  • OtherUnruptured intracranial aneurysms

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: at 5 year

  2. 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

    Time frame: at 5 year

  3. 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

    Time frame: at 5 year

Secondary outcomes

  1. 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

    Time frame: at 5 year

  2. 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

    Time frame: at 5 year

  3. 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

    Time frame: at 5 year

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Study locations

1 site
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310029, China
    • Gao Chen · Contact
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05576727
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, The Central Hospital of Lishui City, Ningbo Medical Center Lihuili Hospital
Responsible party
Sponsor
First posted
Oct 12, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 13, 2022

Study contacts

Gao Chen
Contact
d-chengao@zju.edu.cn
+86 0571 87784813

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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