Today is 2020-08-05

Diagnostic Performance of CT-derived resting Pd/Pa vs CT-derived FFR in Coronary Lesion Severity Assessment
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注册号:

Registration number:

ChiCTR2000034345 

最近更新日期:

Date of Last Refreshed on:

2020-07-03 

注册时间:

Date of Registration:

2020-07-02 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

冠状动脉CT-Pd/Pa与CT-FFR的临床准确度研究 

Public title:

Diagnostic Performance of CT-derived resting Pd/Pa vs CT-derived FFR in Coronary Lesion Severity Assessment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

冠状动脉CT-Pd/Pa与CT-FFR的临床准确度研究 

Scientific title:

Diagnostic Performance of CT-derived resting Pd/Pa vs CT-derived FFR in Coronary Lesion Severity Assessment 

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:

曾勇 

研究负责人:

曾勇 

Applicant:

Yong Zeng 

Study leader:

Yong Zeng 

申请注册联系人电话:

Applicant telephone:

+86 13501373114 

研究负责人电话:

Study leader's telephone:

+86 13501373114 

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:

13501373114@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13501373114@163.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:

北京市朝阳区安贞路2号 

研究负责人通讯地址:

北京市朝阳区安贞路2号 

Applicant address:

2 Anzhen Rode, Chaoyang District, Beijing, China 

Study leader's address:

2 Anzhen Rode, Chaoyang 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:

 

申请人所在单位:

首都医科大学附属北京安贞医院 

Applicant's institution:

Beijing Anzhen Hospital, Capital Medical University 

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:

首都医科大学附属北京安贞医院 

Primary sponsor:

Beijing Anzhen Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市朝阳区安贞路2号 

Primary sponsor's address:

2 Anzhen Rode, Chaoyang 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):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

首都医科大学附属北京安贞医院

具体地址:

北京市朝阳区安贞路2号

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University

Address:

2 Anzhen Rode, Chaoyang District

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

冠心病 

Target disease:

coronary 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 

研究目的:

本研究旨在比较基于CT影像技术计算的静息Pd / Pa(CT-(Pd / Pa)静息)与有创静息Pd / Pa和CT-FFR技术相较有创FFR之间的诊断准确性。 此外,通过比较CT的静息Pd / Pa和CT-FFR的准确性,首次研究了简化的微循环阻力模型的误差和CT-FFR计算中冠状动脉供血状态的差异。 

Objectives of Study:

This study aims to investigate the diagnostic accuracies between the CT-derived resting Pd/Pa (CT-(Pd/Pa)rest) with invasive resting Pd/Pa and CT-FFR with invasive FFR, respectively. In addition by comparing the accuracy performance of CT-derived resting Pd/Pa and CT-FFR, the error of the simplified microcirculatory resistance model and discrepancy of blood supply status in coronary arteries in CT-FFR calculation is studied for the first time. 

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:

FFR测量手术时间和CCTA检查时间间隔少于30天且在探测器排数至少为64排的仪器上完成的患者; 

Inclusion criteria

patients who underwent coronary CTA by 64-row CT scanners or above, along with invasive coronary angiography (ICA), and FFR measurements within the next 30 days afterwards 

排除标准:

1)严重的术中不良心脏事件(心肌梗塞,心脏死亡或血运重建); 2)并发先天性心脏病; 3)既往冠状动脉搭桥手术或支架置入术; 4)安装起搏器; 5)人造心脏瓣膜; 6)分叉狭窄; 7)慢性完全闭塞; 8)CTA数据的非诊断质量; 9)体重指数(BMI)≥35; 10)既往心肌梗塞; 11)静息Pd / Pa或FFR分析的压力曲线不合格。 

Exclusion criteria:

1) major interprocedural adverse cardiac events (myocardial infarction, cardiac death, or revascularization); 2) complicated congenital heart diseases; 3) previous coronary artery bypass surgery or stenting; 4) installed pacemaker; 5) artificial heart valves; 6) bifurcation stenosis; 7) chronic total occlusion; 8) non-diagnostic quality of CTA data 9) body mass index (BMI)>=35; 10) prior myocardial infarction; 11) unqualified pressure curve for resting Pd/Pa or FFR analysis. 

研究实施时间:

Study execute time:

From2020-04-15To 2020-06-15 

征募观察对象时间:

Recruiting time:

From2020-04-15To 2020-05-15 

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):

基于CT影像技术计算的静息Pd / Pa(CT-(Pd / Pa)静息)

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):

CT-derived resting Pd/Pa (CT-(Pd/Pa)rest)

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):

有创静息Pd / Pa和CT-FFR技术

Index test:

invasive resting Pd/Pa and CT-FFR with invasive FFR

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)

冠心病患者

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):

coronary heart disease

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):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属北京安贞医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

CT-FFR

指标类型:

主要指标 

Outcome:

CT-FFR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Kappa

指标类型:

主要指标 

Outcome:

Kappa

Type:

Primary 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:

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

NA

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

NA

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):

ResMan临床试验公共管理平台

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

ResMan (www.medresman.org)

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-07-02
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