Recruiting NCT06539767
Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Arterial Aneurysm Wall Enhancement on HRMRI. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- High resolution MRI aneurysm features [Time frame: 1 year]
Secondary outcome measures (2)
- postoperative mRS score [Time frame: 1 year]
- postoperative aneurysm occlusion rate [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Zhujiang Hospital — Guangzhou
- Southern medical university, zhujiang hospital — Guangzhou
Identifiers
NCT: NCT06539767 · 2023-KY-127-01