今天是:2019-11-21 星期四

彭鲲医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 全心4D-flow诊断射血分数保留型心力衰竭并预测不良预后因子的研究
下载XML文档

注册号:

Registration number:

ChiCTR1900026783 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2019-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

彭鲲医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 全心4D-flow诊断射血分数保留型心力衰竭并预测不良预后因子的研究 

Public title:

Whole heart 4D flow in the diagnosis of heart failure with preserved ejection fraction and the prediction of adverse prognostic factors 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全心4D-flow诊断射血分数保留型心力衰竭并预测不良预后因子的研究 

Scientific title:

Whole heart 4D flow in the diagnosis of heart failure with preserved ejection fraction and the prediction of adverse prognostic factors 

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:

彭鲲 

研究负责人:

汤光宇 

Applicant:

Peng Kun 

Study leader:

Tang Guangyu 

申请注册联系人电话:

Applicant telephone:

+86 15000589482 

研究负责人电话:

Study leader's telephone:

+86 021-66306242 

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:

pengkun_zoe@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tgy17@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:

上海市延长中路301号 

研究负责人通讯地址:

上海市延长中路301号 

Applicant address:

301 Middle Yanchang Road, Shanghai 

Study leader's address:

301 Middle Yanchang Road, Shanghai 

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:

上海市第十人民医院 

Applicant's institution:

Shanghai Tenth People's Hospital 

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:

上海市第十人民医院 

Primary sponsor:

Shanghai Tenth People's Hospital 

研究实施负责(组长)单位地址:

上海市延长中路301号 

Primary sponsor's address:

301 Middle Yanchang Road, Shanghai 

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

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第十人民医院

具体地址:

延长中路301号

Institution
hospital:

Shanghai Tenth People's Hospital

Address:

301 Middle Yanchang Road

经费或物资来源:

自筹 

Source(s) of funding:

raise independently 

研究疾病:

射血分数保留型心力衰竭 

Target disease:

Heart Failure with preserved Ejection Fraction 

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:

本课题拟对正常对照组、射血分数保留型心力衰竭(HFpEF)组以及射血分数减低型心力衰竭(HFrEF)组进行4D-flow和常规CMR扫描,以目前的临床诊断标准为参考:比较三组间4D-flow和常规CMR结果差异,明确早期诊断HFpEF的影像学标记物及4D-flow技术的诊断效能;通过随访观察入组患者的不良心脏事件,试图筛选出预测不良事件的敏感的影像学标志物。 

Objectives of Study:

The purpose of this study is to carry out 4D flow and conventional CMR scanning in the normal control group, HFpEF group and HFrEF group. Based on the current clinical diagnosis criteria, we compare the results of 4D-flow and conventional CMR among the three groups, and determine the imaging markers and the diagnostic efficiency of 4D-flow technology for early diagnosis of HFPEF. To observe the adverse cardiac events of the patients, and try to screen out the sensitive imaging markers to predict the adverse events. 

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:

1、HFpEF患者的入组标准: 1)具有典型的心力衰竭的症状及体征; 2)LVEF≥ 50%、且左心室不大; 3)组织多普勒证实的左心室舒张功能障碍:间隔和侧壁平均e’< 9cm/s;E/e′≥13。 2、HFrEF患者的入组标准: 1)典型的心力衰竭的症状及体征,超过3个月; 2)LVEF < 40%。 3、健康受室者入组标准: 1)患者与其家属均自愿接受此次检查; 2)研究方案经医院伦理会批准后实施。 

Inclusion criteria

1. The admission criteria of HFpEF patients were as follows: 1) they had typical symptoms and signs of heart failure; 2) LVEF >= 50%, and left ventricle was not large; 3) diastolic dysfunction of left ventricle confirmed by tissue Doppler: mean e '< 9cm / s in septum and lateral wall; E / E' >= 13. 2. Criteria for HFrEF patients: 1) typical symptoms and signs of heart failure, more than 3 months; 2) LVEF < 40%. 3. The admission criteria of healthy recipients: 1) the patients and their families voluntarily accept the examination; 2) the research scheme will be implemented after being approved by the hospital ethics committee.  

排除标准:

1、HFpEF及HFrEF患者的排除标准:心脏瓣膜病、心包病以及肥厚型心肌病、限制性心肌病等、CMR扫描的任何禁忌症、年龄小于20岁或大于70岁、恶性肿瘤患者、孕妇。 2、健康志愿者排除标准包括: 1)高血压病史,无论有无使用药物治疗史; 2)糖尿病史者,无论有无使用药物治疗; 3)任何心血管疾病史,包括缺血性和非缺血性心肌病,心脏瓣膜病,先天性心脏病; 4)CMR扫描的任何禁忌症; 5)年龄小于20岁或大于70岁; 6)恶性肿瘤患者; 7)孕妇。 

Exclusion criteria:

1. Exclusion criteria for HFpEF and HFrEF patients: heart valve disease, pericardial disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, any contraindications of CMR scan, aged less than 20 years or more than 70 years, malignant tumor patients, pregnant women. 2. Exclusion criteria for healthy volunteers include: 1) history of hypertension, whether or not using drugs; 2) history of diabetes, whether or not using drugs; 3) history of any cardiovascular disease, including ischemic and non ischemic cardiomyopathy, valvular heart disease, congenital heart disease; 4) any contraindications of CMR scanning; 5) age less than 20 years or more than 70 years; 6) malignant Tumor patients; 7) pregnant women. 

研究实施时间:

Study execute time:

From2020-01-01To 2022-12-31 

诊断试验:

Diagnostic Tests:

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):

目前临床缺乏诊断HFpEF的金标准,因此本研究以临床诊断HFpEF为参考标准,即1)具有典型的心力衰竭的症状及体征;2)LVEF≥ 50%、且左心室不大;3)组织多普勒证实的左心室舒张功能障碍:间隔和侧壁平均e’< 9cm/s;E/e′≥13,探寻诊断HFpEF的新的影像标记物。

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):

At present, there is no gold standard to diagnose HFPEF in clinic, so this study takes clinical diagnosis of HFPEF as reference standard, that is, 1) it has typical symptoms and signs of heart failure; 2) LVEF >= 50%, and left ventricle is not large; 3) diastolic dysfunction of left ventricle co

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):

1. Direct Flow;2. Delayed Ejection;3. Retained inflow;4. Residual Volume.

Index test:

1. Direct Flow;2. Delayed Ejection;3. Retained inflow;4. Residual Volume.

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)

射血分数保留型心力衰竭;纳入标准:1)具有典型的心力衰竭的症状及体征;2)LVEF≥ 50%、且左心室不大;3)组织多普勒证实的左心室舒张功能障碍:间隔和侧壁平均e’< 9cm/s;E/e′≥13

例数:

Sample size:

30

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):

HFpEF; inclusion criteria: 1) typical symptoms and signs of heart failure; 2) LVEF >= 50%, and left ventricle is not large; 3) left ventricular diastolic dysfunction confirmed by tissue Doppler: mean e '< 9cm / s in septum and lateral wall; E / E' >= 13.

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):

射血分数减低型心力衰竭;纳入标准:1)典型的心力衰竭的症状及体征,超过3个月;2)LVEF < 40%。

例数:

Sample size:

30

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

HFrEF inclusion criteria: 1) typical symptoms and signs of heart failure, more than 3 months; 2) LVEF < 40%.

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):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第十人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Tenth People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

直接血流量

指标类型:

主要指标 

Outcome:

directe flow

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

延迟射血量

指标类型:

主要指标 

Outcome:

Delayed Ejection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

滞留流入量

指标类型:

主要指标 

Outcome:

Retained inflow

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

剩余容积

指标类型:

次要指标 

Outcome:

Residual Volume

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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 20 years
最大 Max age 70 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):

本研究为临床诊断试验,不涉及随机分组方法

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

This study is a clinical diagnosis trial, and does not involve random grouping method.

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-22
返回列表