Intracranial AneurysmNCT05576727
Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms
An observational study of Intracranial Aneurysm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Unruptured intracranial aneurysms
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of aneurysm by digital subtraction angiography (DSA);
- Age between 18-70 years old;
- Informed consent form for this study was signed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310029
Gao Chen
About this study
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Unruptured intracranial aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unruptured intracranial aneurysmsOther
Extensive clinical, biological and imaging data of unruptured intracranial aneurysm patients will be recorded during a 5 years follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Unruptured Intracranial Aneurysm | Not described Receives: Other: Unruptured intracranial aneurysms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: at 5 year
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: at 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576727
- Sponsor's protocol ID
- UNruAneu
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms
- ClinicalTrials.gov ID
- NCT05576727
- Acronym / sponsor ID
- UNruAneu
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- 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
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unruptured Intracranial Aneurysm | – | Other: Unruptured intracranial aneurysms |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of aneurysm by digital subtraction angiography (DSA);
- Age between 18-70 years old;
- Informed consent form for this study was signed
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unruptured intracranial aneurysmsExtensive clinical, biological and imaging data of unruptured intracranial aneurysm patients will be recorded during a 5 years follow-up. | Other | Unruptured Intracranial Aneurysm |
Primary outcome
Predictive value of coincidence of TWR and NWSS for unruptured aneurysm rupture
Time frame: at 5 year
at 5 years, the value of the factor (coincidence of TWR and NWSS) to predict aneurysm rupture risk will be analyzed
Predictive value of serum TNF-α for unruptured aneurysm rupture
Time frame: at 5 year
at 5 years, the value of the factor (serum TNF-α) to predict aneurysm rupture risk will be analyzed
Predictive value of sex for unruptured aneurysm rupture
Time frame: at 5 year
at 5 years, the value of the factor (sex) to predict aneurysm rupture risk will be analyzed
3 secondary outcomes
Predictive value of coincidence of TWR and NWSS for unruptured aneurysm growth
Time frame: at 5 year
Predictive value of serum TNF-α for unruptured aneurysm growth
Time frame: at 5 year
Predictive value of sex for unruptured aneurysm growth
Time frame: at 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gao Chen (+86 0571 87784813, d-chengao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of coincidence of TWR and NWSS for unruptured aneurysm rupture (time frame: at 5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.