ChiCTR2300076714 版本V1.1 版本创建时间2024/04/18 17:56:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300076714 

最近更新日期：

Date of Last Refreshed on：

 2023-10-17 09:31:32 

注册时间：

Date of Registration：

 2023-10-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

先天性心脏病发生因素分析与应对研究

Public title：

Research of Analysis and response to the factors of congenital heart disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

先天性心脏病发生因素分析与应对研究

Scientific title：

Research of Analysis and response to the factors of congenital heart disease

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：

梁佩珊 

研究负责人：

任广立 

Applicant：

Peishan Liang 

Study leader：

Guangli Ren 

申请注册联系人电话：

Applicant telephone：

 +86 159 1747 6815

研究负责人电话：

Study leader's
telephone：

+86 133 9261 2783

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：

 940461898@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 guangliren@hotmail.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：

中国广东省广州市越秀区流花路111号南部战区总医院

研究负责人通讯地址：

中国广东省广州市越秀区流花路111号南部战区总医院

Applicant address：

General Hospital of Southern Theatre Command of PLA, No.111 Liuhua Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address：

General Hospital of Southern Theatre Command of PLA, No.111 Liuhua Road, Yuexiu District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

 510010

研究负责人邮政编码：

Study leader's postcode：

 510010

申请人所在单位：

中国人民解放军南部战区总医院

Applicant's institution：

General Hospital of Southern Theatre Command of PLA

研究负责人所在单位：

中国人民解放军南部战区总医院

Affiliation of the Leader：

General Hospital of Southern Theatre Command of PLA

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：

 NZLLKZ2023003

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：

南部战区总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee,General Hospital of Southern Theatre Command of PLA

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-03-03 00:00:00

伦理委员会联系人：

周泉

Contact Name of the ethic committee：

Quan Zhou

伦理委员会联系地址：

中国广东省广州市越秀区流花路111号南部战区总医院

Contact Address of the ethic committee：

General Hospital of Southern Theatre Command of PLA, No.111 Liuhua Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 186 0081 7477

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：

中国人民解放军南部战区总医院

Primary sponsor：

General Hospital of Southern Theatre Command of PLA

研究实施负责（组长）单位地址：

中国广东省广州市越秀区流花路111号南部战区总医院

Primary sponsor's address：

General Hospital of Southern Theatre Command of PLA, No.111 Liuhua Road, Yuexiu District, Guangzhou, Guangdong, 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)：

广东省

市(区县)：

1

Country：

China

Province：

Guangdong

City：

1

单位(医院)：

中国人民解放军南部战区总医院

具体地址：

广东省广州市流花路111号

Institution
hospital：

General Hospital of Southern Theatre Command of PLA

Address：

General Hospital of Southern Theatre Command of PLA, No.111 Liuhua Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源：

计生专项科研课题

Source(s) of funding：

Special research projects on birth control

研究疾病：

先天性心脏病  

Target disease：

congenital 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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

诊断性病例对照试验 

Study design：

Diagnostic test: case-control 

研究目的：

通过研究先天性心脏病发生因素，提高先天性心脏病的诊断和治疗的能力  

Objectives of Study：

To improve the diagnosis and treatment of congenital heart disease by studying the factors that contribute to the development of congenital heart disease

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）年龄≤14岁；（2）超声心动图确诊先天性心脏病

Inclusion criteria

(1)Age ≤ 14 years;(2)Echocardiography to confirm the diagnosis of congenital heart disease

排除标准：

（1）并发感染者；（2）临床资料不全者

Exclusion criteria：

(1) Those with co-infection; (2) Those with incomplete clinical information

研究实施时间：

Study execute time：

从 From 2022-07-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-07-01 00:00:00 至 To 2023-11-30 00:00:00

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）：

根据病史、查体、症状、心电图、心脏彩超检查等综合判定先天性心脏病，主要依据心脏彩超的结果。 心脏彩超调节探头频率在３～５ ＭＨｚ，对胎儿腹部在常规心脏诊断方式依据下进行横切，获取胎儿标准四腔心切面。活动旋转探头，对左右心室流出道切面和三血管平面进行扫查。通过不同切面检查胎儿心脏位置、大小、心房、心室、血流信号等情况，根据静脉、心房—心室—大动脉的顺序依次检查胎儿各个连接，观察室间隔、房间隔、心室壁及心包是否存在异常，并通过多普勒血流显像观察房室瓣口、室间隔、房间隔和大动脉内的血流速度、方向和性质。 常见先天性心脏病类型主要包括：左心发育不良综合征，主要表现为左心房左心室明显缩小；单心房单心室，主要表现为仅见一房一室和一组房室瓣，大动脉交叉消失；法洛四联症，主要表现为室间隔连续中断，主动脉骑跨，肺动脉狭窄；室间隔缺损，主要变现为室间隔肌部或膜周部连续中断。 有研究显示超声心动图检出心内结构畸形特异性为97.07%、敏感度为99.83%和受试者工作特征曲线(receiver operator characteristic curve, ROC曲线)分析对先天性患儿的疾病预测价值为0.985。

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):

The determination of congenital heart disease is based on a combination of history, physical examination, symptoms, and cardiac ultrasound, which is primarily based on the results of cardiac ultrasound. Cardiac ultrasound is performed with the probe frequency adjusted at 3-5 MHz, and the fetal abdomen is transected on the basis of conventional cardiac diagnostic modalities to obtain a standard four-chamber view of the fetal heart. The movable rotating probe was used to sweep the right and left ventricular outflow tract views and the three-vessel plane. The fetal heart position, size, atria, ventricles, and blood flow signals were examined through different sections, and the fetal connections were examined sequentially according to the order of veins, atria-ventricles-arteries to observe the presence of abnormalities in the interventricular septum, interatrial septum, ventricular wall, and pericardium, and the atrioventricular orifices and interventricular septum were observed by Doppler flow visualization, interventricular septum and within the aorta by Doppler flow imaging to observe the velocity, direction and nature of blood flow. Common types of congenital heart disease include: hypoplastic left heart syndrome, which is characterized by a markedly reduced size of the left atrium and left ventricle; single atrium and single ventricle, which is characterized by the presence of only one atrium, one ventricle, and one set of atrioventricular valves, and the disappearance of the aortic crossings; tetralogy of Fallot, which is characterized by the continuous interruption of the interventricular septum, the aortic ride, and the stenosis of pulmonary arteries; and ventricular septal defect, which is characterized by a continuous interruption of the myocardial or periventricular portion of the interventricular septum. Some studies have shown that echocardiographic detection of intracardiac structural malformations has a specificity of 97.07%, a sensitivity of 99.83%, and a predictive value of 0.985 for disease prediction in congenital children analyzed by the Receiver Operator Characteristic Curve (ROC curve).

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、先天性心脏病患儿血清进行高通量测序 2、qRT-PCR验证血清高通量测序结果 3、受试者工作特征曲线(receiver operator characteristic curve, ROC曲线)分析对先天性患儿的疾病预测价值

Index test:

1. High-throughput sequencing of serum from children with congenital heart disease. 2.qRT-PCR validation of serum high-throughput sequencing results. 3.Receiver operator characteristic curve (ROC curve) analysis of the predictive value of disease in children with congenital heart disease.

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）

先天性心脏病病患儿，包括室间隔缺损、房间隔缺损、动脉导管未闭等类型，表现为体型瘦长、面色苍白、口唇、指甲青紫或者哭闹或活动后青紫，杵状指趾，乏力多汗、活动后气促、经常感冒、反复呼吸道感染，易患肺炎和生长发力迟缓等。 听诊发现心脏有持续性杂音；出现心电图异常；超声心动图检查出现异常血流变化，左心发育不良综合征，主要表现为左心房左心室明显缩小；单心房单心室，主要表现为仅见一房一室和一组房室瓣，大动脉交叉消失；法洛四联症，主要表现为室间隔连续中断，主动脉骑跨，肺动脉狭窄；室间隔缺损，主要变现为室间隔肌部或膜周部连续中断。

例数:

Sample size:

20

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):

Children with congenital heart disease, including ventricular septal defects, atrial septal defects, and arterial ductus arteriosus, present with long and thin body, pale face, blue lips and nails, or bruising after crying or activity, pestle-like fingers and toes, weakness and sweating, shortness of breath after activity, frequent colds, recurrent respiratory infections, susceptibility to pneumonia, and delayed growth and development. Auscultation reveals a persistent murmur in the heart; an abnormal electrocardiogram is present; echocardiography reveals abnormal blood flow changes; hypoplastic left heart syndrome, mainly manifested as a markedly reduced size of the left atrium and left ventricle; single atrium and single ventricle, mainly manifested as a single atrium and a set of atrioventricular valves, and the disappearance of aortic crossover; tetralogy of Fallot, mainly manifested as a continuous disruption of the interventricular septum, aortic riding, and pulmonary artery stenosis; and interventricular septal In tetralogy of Fallot, continuous interruption of the ventricular septum, aortic ride, and pulmonary stenosis are the main manifestations.

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）：

病毒性心肌炎患者、心力衰竭等疾病患者，可结合病史、症状体征、验血、心脏超声检查进行鉴别。

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:

Patients with viral myocarditis, heart failure, and other diseases can be identified by history, signs and symptoms, blood tests, and cardiac ultrasound.

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州 

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

 中国人民解放军南部战区总医院 

单位级别：

 三甲 

Institution
hospital：

General Hospital of Southern Theatre Command of PLA

Level of the institution：

Tertiary A

测量指标：

Outcomes：

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 0 岁 years
最大 Max age 14 岁 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）：

由临床医生对先天性心脏病患儿和正常体检患儿按“CHD组和正常对照组”简单随机分组。

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

Children with congenital heart disease and children with normal physical examination were simply randomized by clinicians into "CHD group and normal control group".

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否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）：

临床试验公共管理平台 IPD（http://www.medresman.org.cn）。

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

ResMan IPD (http://www.medresman.org.cn) .

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：

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)

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

Data capture and management consists of two components, the Case Record Form (CRF) and the Electronic Data Capture and Management System (EDC).

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：

  2023-10-17 09:31:22