今天是:2019-06-24 星期一

18F-NaF PET/CT在弥漫性冠脉病变不稳定性斑块的应用
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注册号:

Registration number:

ChiCTR1900022527 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

18F-NaF PET/CT在弥漫性冠脉病变不稳定性斑块的应用 

Public title:

The Role Of 18F-NaF PET/CT Imaging of Coronary Artery Calcification in CAD Patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

18F-NaF PET/CT在弥漫性冠脉病变不稳定性斑块的应用 

Scientific title:

The Role Of 18F-NaF PET/CT Imaging of Coronary Artery Calcification in CAD Patients 

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:

朱紫薇 

研究负责人:

张晓丽 

Applicant:

Zhu Ziwei 

Study leader:

Zhang Xiaoli 

申请注册联系人电话:

Applicant telephone:

+86 13701076126 

研究负责人电话:

Study leader's telephone:

+86 010-6800 5458 

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:

rachelzzw@126.com 

研究负责人电子邮件:

Study leader's E-mail:

xlzhang68@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:

北京市朝阳区安贞路2号北京安贞医院核医学科 

研究负责人通讯地址:

北京市朝阳区安贞路2号北京安贞医院核医学科 

Applicant address:

2 Anzhen Road, Chaoyang District, Beijing, China 

Study leader's address:

2 Anzhen Road, 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:

Capital Medical University Affiliated Beijing Anzhen Hospital,Department of Nuclear Medicine  

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:

2018055X 

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:

首都医科大学附属北京安贞医院医学伦理委员会 

Name of the ethic committee:

Capital Medical University Affiliated BeiJing Anzhen Hospital,Medical ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-05 

伦理委员会联系人:

吴朝阳 

Contact Name of the ethic committee:

Wu Chaoyang 

伦理委员会联系地址:

北京市朝阳区安贞路2号 医务处 

Contact Address of the ethic committee:

Department of Medical Affairs, 2 Anzhen Road, Chaoyang District, Beijing, China 

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:

Capital Medical University Affiliated Beijing Anzhen Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区安贞路2号北京安贞医院核医学科 

Primary sponsor's address:

2 Anzhen Road, 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

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

Address:

2 Anzhen Road, Chaoyang District, Beijing, China

经费或物资来源:

北京市科委项目 临床特色应用研究课题 PET/CT分子显像评价冠心病心肌存活性和脑神经细胞葡萄糖代谢水平的相关性研究  

Source(s) of funding:

Beijing Science and Technology Commission of the project 

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:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

进一步探讨18F-NaF PET/CT显像在冠心病不稳定心绞痛弥漫性病变的应用价值 

Objectives of Study:

To further discuss the specificity of 18F-NaF PET/CT imaging on diffused cardiovascular disease 

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:

(1)不稳定性心绞痛拟行冠脉内膜剥脱后行冠脉搭桥术患者 (2)冠状动脉造影显示患者冠状动脉为弥漫性病变: (3)配合检查患者 (4)签署知情同意书 

Inclusion criteria

1. unstable angina pectoris coronary endarterectomy row in Patients Undergoing Coronary Artery Bypass Grafting; 2. coronary angiography showed diffuse coronary lesions in patients; 3. patients who cooperate; 4. patients who is willing to sign ICF. 

排除标准:

(1)心肌梗死急性期内,无法行搭桥手术患者 (2)辅助检查提示桥血管移植物不能使用: (3)既往冠状动脉三支血管均有PCI手术史患者 (4)不配合检查的患者 (5)孕产妇 

Exclusion criteria:

1. patients in the acute phase of myocardial infarction; 2. Auxiliary examination prompted bridge vascular grafts could not be used; 3. History of previous PCI three coronary Vascular Surgery Patients; 4. patient who do not cooperate,and are not willing to sign ICF; 5. pregnancy. 

研究实施时间:

Study execute time:

From2018-02-10To 2020-06-10 

干预措施:

Interventions:

组别:

Case series

样本量:

60

Group:

Case series

Sample size:

干预措施:

行18F-NaF PET/CT显像观察

干预措施代码:

Intervention:

18F-NaF PET/CTimaging

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):

北京安贞医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Anzhen Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

半定量摄取值

指标类型:

主要指标 

Outcome:

SUV

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:

冠状动脉内膜

组织:

Sample Name:

coronary intimal lesion

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 30 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):

N/A

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

N/A

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):

网络公开原始数据: ResMan

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

share the raw data on the internet: ResMan

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:

由参与成员进行数据采集及上传和管理

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

Data Acquisition and upload and manage by participants

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-15
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