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Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics

Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06539767
Enrollment
1000
Registered
2024-08-06
Start date
2023-01-01
Completion date
2025-12-31
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Aneurysm Wall Enhancement on HRMRI

Brief 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.

Interventions

None listed

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
High resolution MRI aneurysm features1 yearEnhancement 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) .

Secondary

MeasureTime frameDescription
postoperative mRS score1 yearMRS 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.
postoperative aneurysm occlusion rate1 yearRaymond classification, grade I: complete embolism; Grade II: residual aneurysm neck;

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026