今天是:2020-04-08 星期三

基于高分辨血管壁磁共振(VW-MRI)及影像组学评估颅内动脉瘤破裂风险的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR2000031263 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于高分辨血管壁磁共振(VW-MRI)及影像组学评估颅内动脉瘤破裂风险的临床研究 

Public title:

Relationship between aneurysm wall enhancement and rupture rate in patients with unruptured intracranial aneurysms: a high-resolution vessel wall magnetic resonance imaging (VW-MRI) study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于高分辨血管壁磁共振(VW-MRI)及影像组学评估颅内动脉瘤破裂风险的临床研究 

Scientific title:

Relationship between aneurysm wall enhancement and rupture rate in patients with unruptured intracranial aneurysms: a high-resolution vessel wall magnetic resonance imaging (VW-MRI) study 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

全凯 

研究负责人:

朱巍 

Applicant:

Kai Quan 

Study leader:

Wei Zhu 

申请注册联系人电话:

Applicant telephone:

+86 18930063601 

研究负责人电话:

Study leader's telephone:

+86 18621120936 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

abcmo@163.com 

研究负责人电子邮件:

Study leader's E-mail:

drzhuwei@fudan.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市静安区乌鲁木齐中路12号华山医院6号楼13楼医生办公室 

研究负责人通讯地址:

上海市静安区乌鲁木齐中路12号华山医院6号楼13楼医生办公室 

Applicant address:

12 Middle Wulumuqi Road, Jing'an District, Shanghai, China  

Study leader's address:

12 Middle Wulumuqi Road, Jing'an District, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

200040 

研究负责人邮政编码:

Study leader's postcode:

200040 

申请人所在单位:

复旦大学附属华山医院神经外科 

Applicant's institution:

Department of Neurosurgery, Huashan Hospital, Fudan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

IRB 2017- D386 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

复旦大学附属华山医院伦理审查委员会 

Name of the ethic committee:

Ethics Committee of Huashan Hospital, Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-29 

伦理委员会联系人:

吴翠云 

Contact Name of the ethic committee:

Cuiyun Wu 

伦理委员会联系地址:

上海市静安区乌鲁木齐中路12号复旦大学附属华山医院门诊9楼伦理审查委员会办公室 

Contact Address of the ethic committee:

12 Middle Wulumuqi Road, Jing'an District, Shanghai, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

复旦大学附属华山医院 

Primary sponsor:

Huashan Hospital, Fudan University 

研究实施负责(组长)单位地址:

上海市静安区乌鲁木齐中路12号 

Primary sponsor's address:

12 Middle Wulumuqi Road, Jing'an District, Shanghai, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

复旦大学附属华山医院

具体地址:

静安区乌鲁木齐中路12号

Institution
hospital:

Huashan Hospital, Fudan University

Address:

12 Middle Wulumuqi Road, Jing'an District

经费或物资来源:

国自然面上项目(81571102)、上海市卫生计生系统百人计划(2017BR006)、上海市“脑与类脑智能”市级重大科技专项资助 (No.2018SHZDZX03) 和张江实验室 

Source(s) of funding:

National Natural Science Foundation of China (No. 81571102), the outstanding academic leaders program of Shanghai Municipal Commission of Health and Family Planning (No. 2017BR006),Shanghai Municipal  

研究疾病:

脑动脉瘤 

Target disease:

Intracranial aneurysm 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

高分辨血管壁磁共振(VW-MRI)是一种新的评估颅内未破裂动脉瘤的影像技术,然而其影像学特征与实际病理学改变目前尚不清楚。以往研究表明:瘤壁强化代表动脉瘤高进展/破裂风险。我们的前期研究已证明高分辨VW-MRI不同强化类型分别反映动脉瘤瘤壁高炎症水平及局部斑块形成,对于颅内未破裂动脉瘤的干预时机/治疗选择具有重要意义。但目前研究结果主要限于队列形态学研究,缺乏大样本数据支持。在本研究中,我们将利用影像组学技术建立高分辨VW-MRI颅内未破裂动脉瘤数字化、可视化影像学模型,从而探索高分辨VW-MRI评估颅内未破裂动脉瘤瘤壁结构及炎症水平的作用;并进一步建立基于高分辨VW-MRI的颅内动脉瘤破裂风险影像评估体系。 

Objectives of Study:

High-resolution vessel wall magnetic resonance imaging(VW-MRI)is a promising technique for assessing wall structures of unruptured intracranial aneurysms (UIAs). However, the relationship between aneurysmal high-resolution vessel wall magnetic resonance imaging features and their histopathologic mechanism remains poorly understood. Previous studies demonstrated that gadolinium-enhancement of the aneurysm wall on VW-MRI reflects aneurysm wall inflammation and may therefore be a marker for aneurysm instability. The previous research work of our team show Different high-resolution VW-MRI enhancement features may represent variable inflammation status of a UIA wall, and we assume that high-resolution VW-MRI can aid the surgical planning for UIAs. However, the current research results are mainly limited to cohort studies and lack of large scale investigations. In this study, we will use radiomics to establish a digital, visual imaging model of high-resolution VW-MRI on UIAs, and exploring the role of high-resolution VW-MRI in evaluating the structure and inflammation levels of UIAs. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

共计纳入约1500例在复旦大学附属华山医院住院治疗的未破裂颅内动脉瘤患者(手术夹闭300,随访1200),纳入标准为: 1、年龄在18-75岁之间,(男女不限); 2、所有患者在评估前均行MRA/CTA/DSA确诊颅内动脉瘤; 3、6月内未发生蛛网膜下腔出血; 4、患者生活自理,KPS评分>60分; 5、患者家属签署知情同意书并配合临床治疗及随访; 6、患者未参加其他类似研究。 

Inclusion criteria

1. Aged 18 to 75 years; 2. Cerebral aneurysm confirmed by DSA, CTA and MRA; 3. Patients without subarachnoid hemorrhage within 6 months; 4. Patients can take care of themselves with a KPS scale (mRS) > 60 ; 5. Patients' families will sign informed consent and cooperate with clinical treatment and follow-up; 6. Patients do not participate in other similar studies. 

排除标准:

1、严重器质性疾病,如急性心梗死、肾功能障碍、恶性肿瘤等; 2、妊娠或哺乳期妇女; 3、合并其他系统难治性疾病如肿瘤、血液病等患者; 4、适合介入栓塞治疗的患者。 

Exclusion criteria:

1. Patients with other systemic refractory disease, such as acute heart infarction, renal dysfunction and malignant tumor, etc.; 2. Pregnant or lactating women, or a positive pregnancy test on admission; 3. Patients with other systemic diseases, such autoimmune disease or blood disorder; 4. Patients selected for interventional embolization. 

研究实施时间:

Study execute time:

From2020-03-18To 2025-12-18 

干预措施:

Interventions:

组别:

case series

样本量:

1500

Group:

case series

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属华山医院 

单位级别:

三甲 

Institution
hospital:

Huashan Hospital, Fudan University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Fujian Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

吉林 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

吉林大学第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Jilin University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

动脉瘤增大

指标类型:

主要指标 

Outcome:

Aneurysm enlargement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动脉瘤破裂

指标类型:

主要指标 

Outcome:

aneurysm rupture

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蛛网膜下腔出血

指标类型:

主要指标 

Outcome:

subarachnoid hemorrhage

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VW-MRI 增强信号

指标类型:

主要指标 

Outcome:

VW-MRI enhancement signal

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

组织巨噬细胞水平

指标类型:

主要指标 

Outcome:

Macrophage level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

动脉瘤壁

组织:

Sample Name:

aneurysmal sac

Tissue:

人体标本去向

使用后保存 

说明

蜡块保存20年

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

中国临床试验中心

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

www.chictr.org.cn

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表(Case Record Form, CRF)

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-26
返回列表