今天是:2019-12-12 星期四

脑白质病变队列研究
下载XML文档

注册号:

Registration number:

ChiCTR1800015295 

最近更新日期:

Date of Last Refreshed on:

2018-03-21 

注册时间:

Date of Registration:

2018-03-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脑白质病变队列研究 

Public title:

the corhort study of cerebral white matter change 

注册题目简写:

 

English Acronym:

SWATCH 

研究课题的正式科学名称:

脑白质病变队列研究 

Scientific title:

the corhort study of cerebral white matter change 

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:

曹立 

研究负责人:

曹立 

Applicant:

Cao Li 

Study leader:

Cao Li 

申请注册联系人电话:

Applicant telephone:

+86 021 64457249 

研究负责人电话:

Study leader's telephone:

+86 021 64457249 

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:

caoli2000@yeah.net 

研究负责人电子邮件:

Study leader's E-mail:

caoli2000@yeah.net 

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:

上海市瑞金二路197号瑞金医院神经内科 

研究负责人通讯地址:

上海市瑞金二路197号瑞金医院神经内科 

Applicant address:

197 Secondary Ruijin Road, Huangpu District, Shanghai, China  

Study leader's address:

197 Secondary Ruijin Road, Huangpu District, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

200025 

研究负责人邮政编码:

Study leader's postcode:

200025 

申请人所在单位:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital, Shanghai Jiao Tong University School of medicine  

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:

2017211 

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:

瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin Hospital Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-18 

伦理委员会联系人:

王译峰 

Contact Name of the ethic committee:

wangyifeng 

伦理委员会联系地址:

上海市瑞金二路197号瑞金医院 

Contact Address of the ethic committee:

197 Secondary Ruijin Road, Huangpu 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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital, Shanghai Jiao Tong University School of medicine 

研究实施负责(组长)单位地址:

上海市瑞金二路197号瑞金医院 

Primary sponsor's address:

197 Secondary Ruijin Road, Huangpu 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):

上海交通大学医学院附属瑞金医院

具体地址:

上海市瑞金二路197号瑞金医院

Institution
hospital:

Ruijin Hospital, Shanghai Jiao Tong University School of medicine

Address:

197 Secondary Ruijin Road, Huangpu District, Shanghai, China

经费或物资来源:

上海市教育委员会高峰高原学科建设计划 

Source(s) of funding:

Shanghai Municipal Education Commission: Gaofeng Clinical Medicine Grant Support  

研究疾病:

脑白质病变 

Target disease:

cerebral white matter change 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

脑白质病变(Cerebral White Matter Change)即脑室旁和半卵圆中心白质的双侧对称区域出现头颅电子计算机体层扫描(CT)上弥漫性低密度影或磁共振成像(MRI)T2加权像上出现高信号病灶。其患病率较高,并随着年龄的增加而增加。因现有医学水平有限,对脑白质病变认识并不充分,许多患者被简单地诊断为“腔隙性脑梗死”,从而导致许多潜在患者被遗漏。本研究旨在通过建立脑白质病变临床数据库和生物标本库,并进行长期的定期观察和随访,系统探究脑白质病变的病因,及脑白质病变患者认知功能,步态障碍,卒中风险相关性研究,探究相应发病机制,制定全面的诊疗规范,进而为患者提供针对性的健康维护措施。 

Objectives of Study:

Cerebral White Matter Change: Bilateral symmetry of the paraventricular and semi-oval centers of white matter lesions occur on cranial computed tomography (CT) with diffuse low density or high signal lesions in magnetic resonance imaging (MRI) T2 weighted images. Its prevalence is high and increases with age. Due to the limited level of existing medical knowledge and insufficient understanding of white matter lesions, many patients are simply diagnosed as "lacunar infarcts," resulting in the omission of many potential patients. The purpose of this study is to establish a clinical database and biological specimen library of white matter lesions and to conduct regular long-term observation and follow-up to systematically explore the etiology of white matter lesions and cognitive function, gait disorders and stroke risk in patients with white matter lesions Research, explore the corresponding pathogenesis, develop a comprehensive treatment norms, and then provide patients with targeted healthy maintenance measures. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1)年龄小于70岁; 2)头颅MRI中T2 flair序列提示脑白质病变(脑室旁或深部白质) 

Inclusion criteria

1) Aged less than 70 years old; 2) T2 flair sequence in head MRI suggests white matter lesions (periventricular or deep white matter). 

排除标准:

1)既往有脑梗死或脑出血病史,本次入组前存在神经功能残障(mRS评分>0分) 2)6个月内房颤或心肌梗死病史 3)显著的出血性疾病,比如凝血因子缺乏等 4)起病6个月内的脑肿瘤 5)明确的精神疾病史 6)严重的肾脏或肝脏疾病、其他部位肿瘤或危重病 7)未能签署知情同意书 

Exclusion criteria:

1) Previous history with cerebral infarction or cerebral hemorrhage, neurological disability before admission (mRS score>0); 2) History of atrial fibrillation or myocardial infarction within 6 months; 3) Significant bleeding disorders, such as clotting factor deficiency; 4) onset of brain tumors within 6 months; 5) a clear history of mental illness; 6) Severe kidney or liver disease, other site tumors, or critical illness; 7) Failed to sign informed consent. 

研究实施时间:

Study execute time:

From2018-04-01To 2028-04-01 

干预措施:

Interventions:

组别:

Case series

样本量:

5000

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

no

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):

黄浦区 

Country:

China 

Province:

Shanghai 

City:

Huangpu District 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital,Shanghai Jiao Tong University School of medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

认知

指标类型:

次要指标 

Outcome:

congnitive

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

步态

指标类型:

次要指标 

Outcome:

gait

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像

指标类型:

主要指标 

Outcome:

image

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:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction 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 years
最大 Max age 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):

以瑞金医院神经内科为牵头的多中心研究,研究对象为门诊就诊的脑白质病变患者及其家属,且由至少2名神经内科专科医生诊断,年龄、性别、名族不限。

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

A multicenter study based on neurology in Ruijin hospital was conducted. The subjects were white matter lesions and their families in outpatients. They were diagnosed by at least 2 neurologics. Age, sex and family name were not limited.

盲法:

Blinding:

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):

2028-10-01 发表论文形式公开

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

2028-10-01 share IPD with papers published

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

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

case record form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-03-21
返回列表