Today is 2022-05-24

Performance Differences between NYHA Functional Classification and Diastolic Dysfunction Grade in Perioperative Risk Prediction
download

注册号:

Registration number:

ChiCTR2100048582 

最近更新日期:

Date of Last Refreshed on:

2022-03-20 

注册时间:

Date of Registration:

2021-07-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

心功能分级和心脏舒张功能分级对麻醉手术风险预测的差异性 

Public title:

Performance Differences between NYHA Functional Classification and Diastolic Dysfunction Grade in Perioperative Risk Prediction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心功能分级和心脏舒张功能分级对麻醉手术风险预测的差异性 

Scientific title:

Performance Differences between NYHA Functional Classification and Diastolic Dysfunction Grade in Perioperative Risk Prediction 

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:

金小高 

研究负责人:

金小高 

Applicant:

Jin Xiaogao 

Study leader:

Jin Xiaogao 

申请注册联系人电话:

Applicant telephone:

+86 18378344400 

研究负责人电话:

Study leader's telephone:

+86 18378344400 

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:

jinxiaogao@yeah.net 

研究负责人电子邮件:

Study leader's E-mail:

jinxiaogao@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:

河南省郑州市桐柏路19号 

研究负责人通讯地址:

河南省郑州市桐柏路19号 

Applicant address:

19 Tongbai Road, Zhengzhou, He'nan, China 

Study leader's address:

19 Tongbai Road, Zhengzhou, He'nan, 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:

郑州大学附属郑州中心医院 

Applicant's institution:

Zhengzhou Central Hospital Affiliated to Zhengzhou 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:

202143 

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:

郑州市中心医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Zhengzhou Central Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-07-02 

伦理委员会联系人:

刘瑞华 

Contact Name of the ethic committee:

Liu Ruihua 

伦理委员会联系地址:

河南省郑州市桐柏路19号 

Contact Address of the ethic committee:

19 Tongbai Road, Zhengzhou, He'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 371 61172993 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zbdywk@126.com 

研究实施负责(组长)单位:

郑州大学附属郑州中心医院 

Primary sponsor:

Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, 450007, China 

研究实施负责(组长)单位地址:

河南省郑州市桐柏路19号 

Primary sponsor's address:

19 Tongbai Road, Zhengzhou, He'nan, 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):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州大学附属郑州中心医院

具体地址:

桐柏路19号

Institution
hospital:

Zhengzhou Central Hospital

Address:

19 Tongbai Road

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州大学第一附属医院

具体地址:

二七区建设东路1号

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University

Address:

1 Jianshe Road East, Erqi District

国家:

中国

省(直辖市):

河南

市(区县):

洛阳

Country:

China

Province:

Henan

City:

Luoyang

单位(医院):

郑州大学附属洛阳市中心医院

具体地址:

西工区中州中路288号

Institution
hospital:

Luoyang Central Hospital Affiliated to Zhengzhou University

Address:

288 Zhongzhou Middle Road, Xigong District

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

心脏疾病 

Target disease:

Heart Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

比较心功能分级和心脏舒张功能分级对预测心脏射血分数正常但舒张功能不全患者麻醉结果的可靠性---前瞻性队列研究。 

Objectives of Study:

Comparing the reliability of cardiac function class and diastolic function class in predicting anesthesia outcome in patients with normal ejection fraction but diastolic dysfunction--a prospective cohort study. 

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:

2021年07月15日-2021年10月15日在上述三家医院进行择期手术的且有心脏超声检查的大于18岁患者。 

Inclusion criteria

All patients with Echo-cardiogram examination who underwent elective surgery in the above three hospitals from July 15, 2021 to October 15, 2021. 

排除标准:

1.EF值大于50%; 2.无心脏瓣膜疾病; 3.无陈旧性心梗患者; 4.无心包炎或纤维化的患者; 5.急诊患者; 6.无心肌肥厚患者。 

Exclusion criteria:

1. The EF value is greater than 50%; 2. No heart valve disease; 3. Patients without old myocardial infarction; 4. Patients without pericarditis or fibrosis; 5. Emergency patients; 6. Patients without myocardial hypertrophy. 

研究实施时间:

Study execute time:

From2021-07-15To 2021-10-15 

征募观察对象时间:

Recruiting time:

From2021-07-15To 2021-10-15 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

心功能分级和心脏舒张功能分级

Index test:

cardiac function class and diastolic function class

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

心脏射血分数正常但舒张功能不全患者

例数:

Sample size:

1000

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

patients with normal ejection fraction but diastolic dysfunction

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学附属郑州中心医院 

单位级别:

三级甲等 

Institution
hospital:

Zhengzhou Central Hospital Affiliated to Zhengzhou University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

洛阳 

Country:

china 

Province:

Henan 

City:

Luoyang 

单位(医院):

郑州大学附属洛阳中心医院 

单位级别:

三级甲等 

Institution
hospital:

Luoyang Central Hospital Affiliated to Zhengzhou University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

B 超

指标类型:

主要指标 

Outcome:

B ultrasound

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:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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):

预试验,没有随机方法

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

None Randomization

盲法:

None

Blinding:

None

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

在对原始数据进行整理后,上传数据到中国临床试验中心,实现共享。2021年11月20日-2022年02月20日: 公开并上传所有数据

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

The clinical trial plan to release all data through Chinese clinical trial registry between November 20, 2021 and February 20, 2021. The public data should be arranged and approved before release.

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, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-07-11
return list