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A retrospective study on the predictive value of inflammation combined with blood lipid index in the risk of coronary heart disease
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注册号:

Registration number:

ChiCTR2000033297 

最近更新日期:

Date of Last Refreshed on:

2020-05-27 

注册时间:

Date of Registration:

2020-05-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评估炎症联合血脂指标对冠心病风险预测价值的回顾性研究 

Public title:

A retrospective study on the predictive value of inflammation combined with blood lipid index in the risk of coronary heart disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项评估炎症联合血脂指标对冠心病风险预测价值的回顾性研究 

Scientific title:

A retrospective study on the predictive value of inflammation combined with blood lipid index in the risk of coronary 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:

孙润陆 

研究负责人:

张玉玲 

Applicant:

Runlu Sun 

Study leader:

Yuling Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13751825652 

研究负责人电话:

Study leader's telephone:

+86 13711675897 

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:

sunrunlu@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zzhangyuling@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:

广东省广州市沿江西路107号 

研究负责人通讯地址:

广东省广州市沿江西路107号 

Applicant address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

Study leader's address:

107 Yanjiang Road West, Guangzhou, Guangdong, 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:

中山大学孙逸仙纪念医院 

Applicant's institution:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 

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:

SYSE-KY-KS-2020-083 

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:

中山大学孙逸仙纪念医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-20 

伦理委员会联系人:

林双秀 

Contact Name of the ethic committee:

Shuangxiu Lin 

伦理委员会联系地址:

广东省广州市沿江西路107号 

Contact Address of the ethic committee:

107 Yanjiang Road West, Guangzhou, Guangdong, 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:

中山大学孙逸仙纪念医院 

Primary sponsor:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市越秀区沿江西路107号 

Primary sponsor's address:

107 Yanjiang Road West, 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

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学孙逸仙纪念医院

具体地址:

越秀区沿江西路107号

Institution
hospital:

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Address:

107 Yanjiang Road West, Yuexiu District

经费或物资来源:

无 

Source(s) of funding:

self-raised 

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:

1. 确定炎症指标(包括hsCRP、ESR、MCP-1和IL-6)对CAD风险的预测价值。 2. 确定血脂指标【包括HDL-C、TC、TG、apo A1、apo B和Lp(a)】及其亚组分(包括HDL2-C和HDL3-C)对CAD风险的预测价值。 3. 评价炎症联合血脂指标对比单一指标对CAD风险预测效能的改善程度。 

Objectives of Study:

1. Determine the predictive value of inflammatory markers (including hsCRP, ESR, McP-1, and il-6) for CAD risk. 2. Determine the predictive value of combined lipid profile [including hdl-c, TC, TG, apo A1, apo B and Lp(a)] and HDL2-C and HDL3-C for CAD risk. 3. To evaluate the improvement of inflammation combined with lipid index in CAD risk prediction compared with a single index. 

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)CAD组:冠状动脉造影示至少1支自身冠状动脉或其主要分支内径狭窄≥50%,明确诊断为冠状动脉粥样硬化性心脏病(CAD) (2)非CAD组:既往无CAD病史,近期无胸痛、胸闷、心悸或活动后气促等症状,并通过生化及心电检测未发现有CAD证据。 

Inclusion criteria

1. CAD group: coronary angiography showed at least one coronary artery or its main branch with diameter stenosis >= 50%, which was definitely diagnosed as coronary atherosclerotic heart disease (CAD); 2. Non CAD group: Patients with no previous history of CAD have no symptoms such as chest pain, chest distress, palpitation or shortness of breath after activity in the near future, and no evidence of CAD has been found through biochemical and ECG tests. 

排除标准:

(1)年龄>80岁; (2)妊娠或哺乳; (3)近1月出现急性冠脉综合征、急性心力衰竭或严重的心律失常; (4)近1月出现感染性或非感染性炎症; (5)心脏瓣膜病、房/室间隔缺损等结构性心脏病或心肌病; (6)严重肝肾功能不全、甲状腺疾病、恶性肿瘤、血液系统疾病; (7)近2月曾行大手术或受到严重外伤; (8)近3月曾使用降脂药、抗氧化剂、糖皮质激素或非甾体类消炎药。 

Exclusion criteria:

1. Patients over 80 years old; 2. Pregnant or nursing patients; 3. Patients with acute coronary syndrome, acute heart failure or serious arrhythmia in the past 1 month; 4. Patients with infectious or non infectious inflammation in recent 1 month; 5. Patients with structural heart disease or cardiomyopathy such as valvular heart disease, atrial / ventricular septal defect; 6. Patients with serious hepatorenal insufficiency, thyroid disease, malignant tumor and hematological system disease; 7. Patients who had major surgery or suffered severe trauma in recent 2 months; 8. Patients who have used lipid-lowering drugs, antioxidants, glucocorticoids or non steroidal anti-inflammatory drugs in recent 3 months. 

研究实施时间:

Study execute time:

From2020-05-20To 2020-07-31 

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):

临床结局

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):

Clinical outcomes

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):

基于炎症指标联合血脂指标的冠心病风险预测模型

Index test:

A predictive model based on inflammation combined with blood lipid index in the risk of coronary 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)

冠心病患者

例数:

Sample size:

200

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):

Patients with CAD.

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):

非冠心病患者

例数:

Sample size:

200

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

Patients without CAD.

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):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学孙逸仙纪念医院 

单位级别:

三级甲等 

Institution
hospital:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

炎症指标(包括hsCRP、ESR、MCP-1和IL-6)

指标类型:

主要指标 

Outcome:

inflammatory factors (hsCRP, ESR, MCP-1 and IL-6)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂谱(HDL-C、TC、TG、apo A1、apo B和Lp(a))

指标类型:

主要指标 

Outcome:

lipid profile (HDL-C, TC, TG, apo A1, apo B和Lp(a))

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:

血样

组织:

Sample Name:

blood sample

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 years
最大 Max age 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):

不适用

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

N/A

盲法:

未说明

Blinding:

Not stated

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:

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):

发表文章后公开原始数据,上传原始数据表

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

Publish the original data after publishing the article, upload the original data record form

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:

采用电子数据采集和管理系统

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

Electric data collection and management system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-27
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