Arterial Aneurysm Wall Enhancement on HRMRINCT06539767
Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
An observational study of Arterial Aneurysm Wall Enhancement on HRMRI, run by Zhujiang Hospital at 2 sites in China.
Trial summary
This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Aneurysm Wall Enhancement on HRMRI
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- How long will I take part?
- 2 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: 1. be older than 18 years of age; 2. complete a high-resolution magnetic resonance exam Exclusion Criteria: 1. aneurysm combined with other cerebrovascular diseases; 2. substandard image quality
Who may be able to join
- Age 18-80 years old, male or infertile female;
- Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment
- The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books;
- Patients willing to cooperate with high-resolution magnetic resonance imaging.
- Patients willing to follow up and evaluate according to clinical research protocol requirements
Who cannot join
- AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms;
- Patients with contraindications for high-resolution magnetic resonance imaging;
- Participants in clinical trials of other drugs or medical devices;
- Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery;
- Patients with poor compliance and inability to cooperate with follow-up;
- Possible or clear history of severe allergy to contrast agents;
- Patients with a life expectancy of less than 2 years;
- Women who are breastfeeding and preparing for pregnancy during the study period
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong
Chuanzhi Duan, 15536363897, doctor_duan@163.com
- Recruiting
Southern medical university, zhujiang hospital
Guangzhou
xin feng, 13681134001@163.com, 13681134001@163.com
About this study
This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.
What is being measured
The primary outcome is the main question the study is designed to answer.
High resolution MRI aneurysm features
Enhancement grade was defined as follows: grade 0 for none enhancement, grade 1 for focal enhancement, involved the neck, the intermediate portion, the dome, or a bleb;grade 2 for thin annular enhancement (maximum thickness≤1 mm) , grade 3 for thick annular enhancement(maximum thickness>1 mm) .
Measured: 1 year
Secondary outcomes (2)
postoperative mRS score
MRS score definition: The MRS score, also known as the Modified Rankin Scale, is a scale used to evaluate the neurological recovery status of stroke patients. It is divided into seven levels, Level 0: completely asymptomatic. Level 1: Despite symptoms, without obvious disabilities, able to complete all frequently engaged work and activities.
Level 2: Mild disability, unable to complete all work and activities, but able to handle personal affairs without the need for assistance from others.
Level 3: Moderate disability, requiring assistance from others to walking without assistance.
Level 4: Severe disability, unable to walk without the help of others, unable to take care of one's own needs.
Level 5: Severe disability, bedridden, urinary and fecal incontinence, requiring continuous care, and requiring multiple 24-hour care from others.
Level 6: Death. The higher the mRS score, the worse the patient's prognosis.
Measured: 1 year
postoperative aneurysm occlusion rate
Raymond classification, grade I: complete embolism; Grade II: residual aneurysm neck;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Aneurysm Wall Enhancement on HRMRIStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539767
- Sponsor's protocol ID
- 2023-KY-127-01
- Status last verified
- Jul 2025
- First submitted
- 4 Jun 2024
- Last updated
- 28 Jul 2025
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
- ClinicalTrials.gov ID
- NCT06539767
- Acronym / sponsor ID
- 2023-KY-127-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: 1. be older than 18 years of age; 2. complete a high-resolution magnetic resonance exam Exclusion Criteria: 1. aneurysm combined with other cerebrovascular diseases; 2. substandard image quality
Key inclusion criteria (5 listed)
- Age 18-80 years old, male or infertile female;
- Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment
- The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books;
- Patients willing to cooperate with high-resolution magnetic resonance imaging.
- Patients willing to follow up and evaluate according to clinical research protocol requirements
Key exclusion criteria (8 listed)
- AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms;
- Patients with contraindications for high-resolution magnetic resonance imaging;
- Participants in clinical trials of other drugs or medical devices;
- Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery;
- Patients with poor compliance and inability to cooperate with follow-up;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
High resolution MRI aneurysm features
Time frame: 1 year
Enhancement grade was defined as follows: grade 0 for none enhancement, grade 1 for focal enhancement, involved the neck, the intermediate portion, the dome, or a bleb;grade 2 for thin annular enhancement (maximum thickness≤1 mm) , grade 3 for thick annular enhancement(maximum thickness>1 mm) .
2 secondary outcomes
postoperative mRS score
Time frame: 1 year
postoperative aneurysm occlusion rate
Time frame: 1 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 28 Jul 2025.
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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.
Southern medical university, zhujiang hospital
Guangzhou, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Aneurysm Wall Enhancement on HRMRI, run by Zhujiang Hospital at 2 sites 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High resolution MRI aneurysm features (time frame: 1 year). 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 28 Jul 2025.