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

• Conditions: Arterial Aneurysm Wall Enhancement on HRMRI

• Registration Number: NCT06539767
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High resolution MRI aneurysm features	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) .

Secondary Outcome Measures

Name	Time	Method
postoperative aneurysm occlusion rate	1 year	Raymond classification, grade I: complete embolism; Grade II: residual aneurysm neck;
postoperative mRS score	1 year	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.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China