今天是:2019-12-08 星期日

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 血糖变异性对糖尿病合并急性心肌梗死患者PCI术后发生造影剂肾病的预测价值
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注册号:

Registration number:

ChiCTR1900024069 

最近更新日期:

Date of Last Refreshed on:

2019-07-01 

注册时间:

Date of Registration:

2019-06-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 血糖变异性对糖尿病合并急性心肌梗死患者PCI术后发生造影剂肾病的预测价值 

Public title:

Glycemic Variability Predicts Contrast-Induced Nephropathy in Diabetic Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血糖变异性对糖尿病合并急性心肌梗死患者PCI术后发生造影剂肾病的预测价值 

Scientific title:

Glycemic Variability Predicts Contrast-Induced Nephropathy in Diabetic Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention 

研究课题代号(代码):

Study subject ID:

江苏省科技厅拨款(项目号BE2016785);中央大学基础研究基金(项目号2242018K40155) 

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:

左鹏飞 

研究负责人:

马根山 

Applicant:

Pengfei Zuo 

Study leader:

Genshan Ma 

申请注册联系人电话:

Applicant telephone:

+86 13512534468 

研究负责人电话:

Study leader's telephone:

+86 13002580569 

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:

zuopengfei1207@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

genshanma@sina.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:

南京市鼓楼区丁家桥87号 

研究负责人通讯地址:

南京市鼓楼区丁家桥87号 

Applicant address:

87 Dingjiaqiao, Nanjing, Jiangsu, China  

Study leader's address:

87 Dingjiaqiao, Nanjing, Jiangsu, 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:

东南大学附属中大医院 

Applicant's institution:

Zhongda Hospital Affiliated to Southeast 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:

东南大学附属中大医院 

Primary sponsor:

Zhongda Hospital Affiliated to Southeast University 

研究实施负责(组长)单位地址:

南京市鼓楼区丁家桥87号 

Primary sponsor's address:

87 Dingjiaqiao, Nanjing, Jiangsu, 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):

江苏省

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

东南大学附属中大医院

具体地址:

南京市鼓楼区丁家桥87号

Institution
hospital:

Zhongda Hospital Affiliated to Southeast University

Address:

87 Dingjiaqiao, Nanjing

经费或物资来源:

江苏省科技厅拨款(项目号BE2016785);中央大学基础研究基金(项目号2242018K40155) 

Source(s) of funding:

Grant of Jiangsu Province Science and Technology Agency (No.BE2016785); Fundamental Research Funds for the Central Universities (No.2242018K40155) 

研究疾病:

造影剂肾病 

Target disease:

Contrast-Induced Nephropathy 

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:

其它 

Study phase:

N/A 

研究目的:

探究血糖变异性对糖尿病合并急性心肌梗死患者PCI术后发生造影剂肾病的预测价值 

Objectives of Study:

we investigated the independent prognostic value of the in-hospital GV in diabetic patients who presented with AMI and were treated with PCI 

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)年龄≥18 岁;(2)患有糖尿病的急性心肌梗死患者;(3)行PCI治疗 

Inclusion criteria

(1) aged>=18 years old; (2) diabetic patients who presented with AMI; (3) treated with PCI. 

排除标准:

(1)糖尿病酮症酸中毒;(2)非酮症高渗性昏迷;(3)需要腹膜、血液透析的终末期肾病及肾移植;(4)心源性休克;(5)心脏骤停需行心肺复苏 

Exclusion criteria:

(1) diabetic ketosis; (2) nonketotic hyperosmolar coma; (3) end-stage renal disease requiring dialysis; (4) cardiogenic shock; (5) cardiac arrest requiring cardiopulmonary resuscitation. 

研究实施时间:

Study execute time:

From2019-07-01To 2020-06-30 

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):

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 outcome

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):

血糖变异性

Index test:

Variability of blood sugar concentration

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)

患有糖尿病的急性心肌梗死患者

例数:

Sample size:

55

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):

diabetic patients who presented with AMI

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):

患有糖尿病无急性心肌梗死患者

例数:

Sample size:

197

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

diabetic patients who presented without AMI

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

东南大学附属中大医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongda Hospital Affiliated to Southeast University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

平均血糖波动幅度

指标类型:

主要指标 

Outcome:

MAGE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌酐

指标类型:

主要指标 

Outcome:

Scr

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SPE, SEN, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SPE, SEN, 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 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):

连续选取252名于2019年7月到2020年6月期间在东南大学附属中大医院行PCI治疗的合并糖尿病的急性心肌梗死患者

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 after
the Study Completed(upload file):

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):

2021年6月公开于ResMan

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

Open by ResMan in June 2021

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:

原始数据和病例报告表由东南大学附属中大医院心内科资料室数据库管理

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

Metadata and case report forms were managed by the database of department of Cardiology reference room,Zhongda Hospital Affiliated to Southeast University

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-24
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