Today is 2020-07-15

Research for Risk Assessment of Cardiovascular Events in Perioperative Period of Non-cardiac Surgery
download

注册号:

Registration number:

ChiCTR1900024645 

最近更新日期:

Date of Last Refreshed on:

2019-07-19 

注册时间:

Date of Registration:

2019-07-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

非心脏手术围术期心血管事件风险评估研究 

Public title:

Research for Risk Assessment of Cardiovascular Events in Perioperative Period of Non-cardiac Surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

非心脏手术围术期心血管事件风险评估研究 

Scientific title:

Research for Risk Assessment of Cardiovascular Events in Perioperative Period of Non-cardiac Surgery 

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:

赵梦林 

研究负责人:

祖凌云 

Applicant:

Menglin Zhao 

Study leader:

Lingyun ZU 

申请注册联系人电话:

Applicant telephone:

+86 18800112759 

研究负责人电话:

Study leader's telephone:

+86 13910609953 

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:

meng_linz@126.com 

研究负责人电子邮件:

Study leader's E-mail:

dr_zly@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:

北京市海淀区学院路38号北京大学医学部 

研究负责人通讯地址:

北京市海淀区北医三院心内科 

Applicant address:

38 College Road, Haidian District, Beijing, China 

Study leader's address:

38 College Road, Haidian District, Beijing, 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:

100191 

申请人所在单位:

北京大学医学部 

Applicant's institution:

Peking University Health Science Center 

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)医伦审第(071-02)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:

北京大学第三医院医学科学研究伦理委员会 

Name of the ethic committee:

Medical Science Ethics Committee of Peking University Third Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-10 

伦理委员会联系人:

洪雪 

Contact Name of the ethic committee:

Xue Hong 

伦理委员会联系地址:

北京市海淀区花园路49号北京大学第三医院 

Contact Address of the ethic committee:

Peking University Third Hospital, 49 Garden Road, Haidian District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-82265571 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

bysyec@163.com 

研究实施负责(组长)单位:

北京大学第三医院 

Primary sponsor:

Peking University Third Hospital 

研究实施负责(组长)单位地址:

北京市海淀区花园路49号北京大学第三医院 

Primary sponsor's address:

49 Garden Road, Haidian District, Beijing, 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):

北京

市(区县):

Country:

Beijing

Province:

Beijing

City:

单位(医院):

北京大学第三医院

具体地址:

北京市海淀区花园路49号

Institution
hospital:

Peking University Third Hospital

Address:

49 Garden Road, Haidian District, Beijing, China

经费或物资来源:

北京大学第三医院临床重点项目科研经费 

Source(s) of funding:

Scientific Research Funds for Key Clinical Projects of the Peking University Third Hospital 

研究疾病:

心血管系统疾病 

Target disease:

Cardiovascular diseases 

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:

通过获取我院非心脏手术围术期心血管事件的大数据,采用大样本队列和巢式病例对照研究,筛选可预测终点事件的指标,构建围手术期心血管事件风险预测模型,从而为降低手术风险并改善预后提供临床决策依据。 

Objectives of Study:

By obtaining large data of cardiovascular events during perioperative period of non-cardiac surgery in our hospital, using large-sample cohort and nested case-control study, we expect to screen indicators for predicting end-point events and construct a risk prediction model for cardiovascular events during perioperative period, so as to provide reference resources for clinical decision-making to reduce surgical risks and improve prognosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

事件组纳入标准: (1)住院行非心脏手术的患者。 (2)病历记录围术期新发心血管事件的症状与体征,同时具有检验、检查 证据支持心血管事件诊断的患者; (3)住院时间为2012 年1 月1 日至2018 年9 月17 日之间的患者。 对照组入选标准: (1)住院行非心脏手术的患者。 (2)病历记录术后未出现主要心血管事件的症状及体征; (3)手术诊断、手术名称、麻醉方式均和病例组相同。 (4)手术时间与病例组最为接近。 

Inclusion criteria

Inclusion criteria for case group: (1) Inpatients that undergoing non-cardiac surgery; (2)The symptoms and signs of ardiovascular events during perioperative period have been recorded by physician .And we can find examination evidence that supports the diagnosis of cardiovascular events in patients; (3) The length of hospitalization was between January 1, 2012 and September 17, 2018. The inclusion criteria of control group: (1) Inpatients that undergoing non-cardiac surgery. (2) They did't have major symptoms and signs about cardiovascular events that were been recorded in the medical records by physician; (3) The diagnosis of operation, the name of operation and the way of anesthesia were the same as those in the case group; (4) The operation time was closest to that of the case group. 

排除标准:

事件组排除标准为: (1)病例资料中心内科会诊记录、检验及检查等资料不全的病例。 (2)正在参加其它应用药物或器械干预的临床研究; 对照排除标准:病例资料中性别、年龄、手术和麻醉记录等不全。 

Exclusion criteria:

The exclusion criteria for event group : (1) Cases with incomplete medical consultation records and examinations in the Case Data Center; (2) The patient who were articipating in clinical research of other interventions with drugs or instruments; Control exclusion criteria: Records about sex, age, operation and anesthesia are Incomplete in case records. 

研究实施时间:

Study execute time:

From2019-08-01To 2022-12-31 

干预措施:

Interventions:

组别:

病例组

样本量:

200

Group:

Case group

Sample size:

干预措施:

干预措施代码:

Intervention:

nothing

Intervention code:

组别:

对照组

样本量:

800

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

nothing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第三医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Routine blood test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

估算的肾小球滤过率

指标类型:

主要指标 

Outcome:

estimated Glomerular Filtration Rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌酐水平

指标类型:

主要指标 

Outcome:

Serum creatinine level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

主要指标 

Outcome:

Blood lipid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌钙蛋白

指标类型:

主要指标 

Outcome:

troponin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酸激酶

指标类型:

主要指标 

Outcome:

creatine kinase

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝学功能

指标类型:

主要指标 

Outcome:

Coagulation function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

electrocardiogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声心动图

指标类型:

主要指标 

Outcome:

Echocardiography

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 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):

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

未确定

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

Uncertainty

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:

通过电子病历系统采集数据,记录在病例报告表中。

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

We collecte datas by the electronic medical record system and recorde in the case report form.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-19
return list