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

NCT06539767 | Recruiting

• 1 other identifier: 2023-KY-127-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Arterial Aneurysm Wall Enhancement on HRMRI

Outcome Measures

Primary Outcomes (1)

• 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) .

  1 year

Secondary Outcomes (2)

• postoperative mRS score

  1 year

• postoperative aneurysm occlusion rate

  1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (2)

Zhujiang Hospital

Guangzhou, Guangdong, China

RECRUITING

Southern medical university, zhujiang hospital

Guangzhou, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

CN (2)