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Association of trimethylamine N-oxide with coronary atherosclerotic burden in patients with non-ST-segment elevation myocardial infarction
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注册号:

Registration number:

ChiCTR1900022366 

最近更新日期:

Date of Last Refreshed on:

2019-04-23 

注册时间:

Date of Registration:

2019-04-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

非ST段抬高型心肌梗死患者三甲胺氮氧化物与冠状动脉粥样硬化负荷的关系 

Public title:

Association of trimethylamine N-oxide with coronary atherosclerotic burden in patients with non-ST-segment elevation myocardial infarction 

注册题目简写:

SZ-NSTEMI trial 

English Acronym:

SZ-NSTEMI trial 

研究课题的正式科学名称:

非ST段抬高型心肌梗死患者三甲胺氮氧化物与冠状动脉粥样硬化负荷的关系 

Scientific title:

Association of trimethylamine N-oxide with coronary atherosclerotic burden in patients with non-ST-segment elevation myocardial infarction 

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:

KHALID BIN WALEED 

研究负责人:

KHALID BIN WALEED 

Applicant:

KHALID BIN WALEED 

Study leader:

KHALID BIN WALEED 

申请注册联系人电话:

Applicant telephone:

+86 13824399004 

研究负责人电话:

Study leader's telephone:

+86 1382439004 

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:

khalid_khan141@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

khalid_khan141@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen 

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:

中国广东深圳市南山区朗山路12号 

研究负责人通讯地址:

中国广东深圳市南山区朗山路12号 

Applicant address:

12 Langshan Road, Nanshan District, Shenzhen, Guangdong, China 

Study leader's address:

12 Langshan Road, Nanshan District, Shenzhen, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

518055 

研究负责人邮政编码:

Study leader's postcode:

518055 

申请人所在单位:

中国医学科学院阜外医院深圳医院 

Applicant's institution:

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen 

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:

YN201901 

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:

中国医学科学院阜外医院深圳医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-11 

伦理委员会联系人:

李剑波 

Contact Name of the ethic committee:

Li Jiang-Bo 

伦理委员会联系地址:

中国广东深圳市南山区朗山路12号 

Contact Address of the ethic committee:

12 Langshan Road, Nanshan District, Shenzhen, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0755 82180028 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

472116547@qq.com 

研究实施负责(组长)单位:

中国医学科学院阜外医院深圳医院 

Primary sponsor:

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen 

研究实施负责(组长)单位地址:

中国广东深圳市南山区朗山路12号 

Primary sponsor's address:

12 Langshan Road, Nanshan District, Shenzhen, 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

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

中国医学科学院阜外医院深圳医院

具体地址:

中国广东深圳市南山区朗山路12号

Institution
hospital:

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Address:

12 Langshan Road, Nanshan District, Shenzhen, Guangdong, China

经费或物资来源:

中国医学科学院阜外医院深圳医院 

Source(s) of funding:

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen 

研究疾病:

非ST段抬高型心肌梗死 

Target disease:

Non-ST segment Elevation Myocardial Infarction  

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:

其它 

Study phase:

N/A 

研究目的:

Aims to evaluate the relationship between plasma TMAO levels, and the complexity and atherosclerotic burden in NSTEMI patients.  

Objectives of Study:

The study aimed to evaluate the relationship between plasma TMAO levels, and the complexity and atherosclerotic burden in NSTEMI patients.  

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:

The present study will include two groups of individuals. The first group will include one hundred NSTEMI patients older than 18 years, those who will undergo emergency or primary coronary angiography or percutaneous coronary intervention (PCI) from 15th April 2019 to 15th April 2020. NSTEMI will define according to current ESC guideline as the presence of acute chest pain, but no persistent ST-segment elevation; electrocardiogram (ECG) change may include ST-segment depression ≥0.05 mV, T-wave inversion ≥0.3 mV or flat T wave, or transient ST-segment elevation ≤0.05 mV or may be normal ECG; and positive elevated troponin T or I and/or CK-MB exceeding the upper limit of normal range. The second group will include healthy individuals without known cardiovascular diseases those who will visit for health screen. The second group purpose will provide the reference interval values for TMAO levels compared to the first group. 

Inclusion criteria

The present study will include two groups of individuals. The first group will include one hundred NSTEMI patients older than 18 years, those who will undergo emergency or primary coronary angiography or percutaneous coronary intervention (PCI) from 15th April 2019 to 15th April 2020. NSTEMI will define according to current ESC guideline as the presence of acute chest pain, but no persistent ST-segment elevation; electrocardiogram (ECG) change may include ST-segment depression ≥0.05 mV, T-wave inversion ≥0.3 mV or flat T wave, or transient ST-segment elevation ≤0.05 mV or may be normal ECG; and positive elevated troponin T or I and/or CK-MB exceeding the upper limit of normal range. The second group will include healthy individuals without known cardiovascular diseases those who will visit for health screen. The second group purpose will provide the reference interval values for TMAO levels compared to the first group. 

排除标准:

The exclusion criteria comprises; ST elevation myocardial infarction or stable or unstable coronary artery disease, heart failure, renal or hepatic disease, severe valvular disease, previous history of PCI or CABG, history stroke or bleeding within 3 months, peripheral arterial disease, pregnancy, chronic obstructive lung disease, acute and chronic infection, and history of cancer.  

Exclusion criteria:

The exclusion criteria comprises; ST elevation myocardial infarction or stable or unstable coronary artery disease, heart failure, renal or hepatic disease, severe valvular disease, previous history of PCI or CABG, history stroke or bleeding within 3 months, peripheral arterial disease, pregnancy, chronic obstructive lung disease, acute and chronic infection, and history of cancer.  

研究实施时间:

Study execute time:

From2019-04-15To 2020-04-15 

征募观察对象时间:

Recruiting time:

From2019-04-15To 2020-04-15 

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

中国医学科学院阜外医院深圳医院 

单位级别:

三甲医院 

Institution
hospital:

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

TMAO related to NSTEMI

指标类型:

主要指标 

Outcome:

TMAO related to NSTEMI

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:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

2 years

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 85 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):

Non-randomization trail. Only 100 NSTEMI patient will be recruited

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

Yes

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):

metadata and protocol

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 yet

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-08
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