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脑心综合征危险因素分析及风险预测模型研究
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注册号:

Registration number:

ChiCTR1900022587 

最近更新日期:

Date of Last Refreshed on:

2019-04-17 

注册时间:

Date of Registration:

2019-04-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脑心综合征危险因素分析及风险预测模型研究 

Public title:

Study for risk factors analysis and risk prediction model of cerebral cardiac syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脑心综合征危险因素分析及风险预测模型研究 

Scientific title:

Study for risk factors analysis and risk prediction model of cerebral cardiac syndrome 

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:

练海娟 

研究负责人:

姚梅琪 

Applicant:

Haijuan Lian 

Study leader:

Meiqi Yao 

申请注册联系人电话:

Applicant telephone:

+86 15088652433 

研究负责人电话:

Study leader's telephone:

+86 13757118732 

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:

1054308543@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zrhlyj@zju.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:

湖州市吴兴区二环东路759号 

研究负责人通讯地址:

浙江省杭州市上城区解放路111号 

Applicant address:

759 Second Ring Road East, Wuxin District, Huzhou, Zhejiang, China 

Study leader's address:

111 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang, 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:

湖州师范学院 

Applicant's institution:

Huzhou 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:

(2019)伦审研第(056)号 

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:

浙江大学医学院附属第二医院人体研究伦理委员会 

Name of the ethic committee:

Ethics Committee for Human Research in The Second Affiliated Hospital of Zhejiang University Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-29 

伦理委员会联系人:

陈泽鑫 

Contact Name of the ethic committee:

Zexin Chen 

伦理委员会联系地址:

浙江省杭州市上城区解放路111号 

Contact Address of the ethic committee:

111 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Zhejiang University Medical College 

研究实施负责(组长)单位地址:

浙江省杭州市上城区解放路88号 

Primary sponsor's address:

88 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第二医院

具体地址:

浙江省杭州市上城区解放路88号

Institution
hospital:

The Second Affiliated Hospital of Zhejiang University Medical College

Address:

88 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang, China

经费或物资来源:

浙江省卫健委科研基金项目 

Source(s) of funding:

Scientific Research Fund Project of Zhejiang Health Commission  

研究疾病:

脑卒中 

Target disease:

stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究基于临床和国内外文献,研究急性脑卒中并发CCS的危险因素,构建科学的风险预测模型。为临床护士对CCS早发现、早诊断、早治疗提供理论依据,降低脑卒中患者CCS发病率及死亡率,改善卒中患者预后。 

Objectives of Study:

Based on clinical and domestic literature, this study studied the risk factors of acute stroke complicated with CCS and constructed a scientific risk prediction model. It provides a theoretical basis for clinical nurses to find, diagnose and treat CCS early, so as to reduce the morbidity and mortality of CCS in stroke patients and improve the prognosis of stroke patients. 

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:

(1)年龄≥18周岁; (2)脑卒中诊断标准:符合全国第四届脑血管病学术会议制定诊断标准,并经头颅CT和(或)磁共振成像检查,和(或)医生电子病例确诊的急性脑卒中患者。 

Inclusion criteria

(1) aged≥18 years old; (2) Patients with acute cerebral apoplexy who meet the diagnostic criteria formulated by the 4th national academic conference on cerebrovascular diseases and are confirmed by head CT and/or MRI and/or his electronic medical record. 

排除标准:

(1)重要资料缺失:入院48小时心肌酶谱和(或)心电图资料不全者; (2)入院前有确诊冠心病病史者; (3)脑卒中起病合并严重心肺功能不全者。 

Exclusion criteria:

(1) Absence of important data: incomplete myocardial enzyme spectrum and/or electrocardiogram data within 48 hours after admission; (2) Patients with a confirmed history of coronary heart disease before admission; (3) Patients with stroke onset and severe cardiopulmonary insufficiency. 

研究实施时间:

Study execute time:

From2019-05-01To 2020-06-01 

征募观察对象时间:

Recruiting time:

From2019-06-01To 2019-12-20 

干预措施:

Interventions:

组别:

case series

样本量:

368

Group:

case series

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第二医院 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital of Zhejiang University Medical College  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

脑心综合征

指标类型:

主要指标 

Outcome:

cerebral cardiac syndrome

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:

NA

组织:

Sample Name:

NA

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 18 years
最大 Max age 99 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):

本研究为观察性研究,凡符合纳入标准的人群均纳入观察,无需随机

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

N/A

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

是Yes

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):

2020-12-01后可由邮箱提供原始数据,邮箱:1054308543@qq.com

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

The original data can be provided by mailbox after 2020-12-01,Mailbox:1054308543@qq.com

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:

EXCEL

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

EXCEL

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-17
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