NCT06539767招募中不适用
Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
Zhujiang Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- High resolution MRI aneurysm features
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
High resolution MRI aneurysm features
时间窗: 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) .
次要结局
- postoperative aneurysm occlusion rate(1 year)
- postoperative mRS score(1 year)
研究者
研究点 (2)
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