今天是:2019-06-17 星期一

急性缺血性脑卒中机械取栓预后影响研究
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注册号:

Registration number:

ChiCTR1900020673 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

急性缺血性脑卒中机械取栓预后影响研究 

Public title:

Prognostic factors of mechanical thrombectomy for acute ischemic stroke 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

急性缺血性脑卒中机械取栓预后影响因素的研究 

Scientific title:

Prognostic factors of mechanical thrombectomy for acute ischemic stroke 

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:

袁正洲 

研究负责人:

何俐 

Applicant:

Yuan Zhengzhou 

Study leader:

He Li 

申请注册联系人电话:

Applicant telephone:

+86 0830 3165661 

研究负责人电话:

Study leader's telephone:

+86 028-85422114 

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:

bibiyou@163.com 

研究负责人电子邮件:

Study leader's E-mail:

heli2003new@126.com 

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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self financing 

研究疾病:

脑梗死 

Target disease:

stroke 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本研究计划回顾性研究急性缺血性脑卒中患者取栓预后不良的危险因素,以提高取栓的有效性及安全性,为临床提供参考。 

Objectives of Study:

This study plans to retrospectively study the risk factors of adverse prognosis of thrombectomy in patients with acute ischemic stroke, in order to improve the effectiveness and safety of thrombectomy and provide reference for clinical practice. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1) 年龄≥18岁;2)影像证实(CTA/ MRA/DSA)颅内外大动脉闭塞;3) 行机械取栓术(包括但不限于Meci,可回收支架,抽吸取栓等血管再通技术);4)行/未进行溶栓/血管成型术。 

Inclusion criteria

1) Aged at least 18 years; 2) imaging confirmation (CTA/MRA/DSA) intracranial and extracranial arterial occlusion; 3) mechanical thrombectomy (including but not limited to Meci, reclaimable stents, thrombectomy and other vascular recanalization techniques); 4) thrombolysis / angioplasty. 

排除标准:

1)严重心肺功能不全患者;2)肾功能衰竭患者;3)血小板低于50*10^9。 

Exclusion criteria:

1) patients with severe cardiopulmonary insufficiency; 2) patients with renal failure; 3) platelets below 50*10^9. 

研究实施时间:

Study execute time:

From2019-02-01To 2020-03-01 

干预措施:

Interventions:

组别:

预后良好组vs预后不良组

样本量:

440

Group:

good outcome group versus Poor outcome group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuang 

City:

 

单位(医院):

西南医科大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Southwest Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuang 

City:

 

单位(医院):

自贡市第三人民医院 

单位级别:

三乙 

Institution
hospital:

The third People's Hospital of Zigong  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuang 

City:

 

单位(医院):

绵阳市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Mianyang Central Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

改良MRS评分

指标类型:

主要指标 

Outcome:

mRS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡

指标类型:

次要指标 

Outcome:

death

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑出血

指标类型:

次要指标 

Outcome:

cerebral hemorrhage

Type:

Secondary 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:

尚未开始

Not yet 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):

连续性纳入入院患者。

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

N/A

盲法:

N/A

Blinding:

N/A

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):

相关论文发表后6年在Resman平台公布数据

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

Related papers published 6 years later,the IPD will be shared on ResMan

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:

采用病例报告表和临床试验电子数据采集系统ResMan采集与管理数据

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

Use Case Record Form (CRF) and Electronic Date Capture(EDC),ResMan to collect and manage data

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-01-12
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