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Prospective and single center clinical study of the effect of hemoglobin level on the prognosis of patients with acute ST segment elevation myocardial infarction after PCI
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注册号:

Registration number:

ChiCTR-ROC-17011542 

最近更新日期:

Date of Last Refreshed on:

2017-06-01 

注册时间:

Date of Registration:

2017-06-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血红蛋白水平对急性ST段抬高型心肌梗死患者PCI术后预后的影响的前瞻性、单中心临床研究 

Public title:

Prospective and single center clinical study of the effect of hemoglobin level on the prognosis of patients with acute ST segment elevation myocardial infarction after PCI 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血红蛋白水平对急性ST段抬高型心肌梗死患者PCI术后预后的影响的前瞻性、单中心临床研究 

Scientific title:

Prospective and single center clinical study of the effect of hemoglobin level on the prognosis of patients with acute ST segment elevation myocardial infarction after PCI 

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:

罗二飞 

研究负责人:

汤成春 

Applicant:

Erfei Luo 

Study leader:

Chengchun Tang 

申请注册联系人电话:

Applicant telephone:

+86 18251981561 

研究负责人电话:

Study leader's telephone:

+86 13914705570 

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:

1458155158@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

tangchengchun@medmail.com.cn 

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 Road, Nanjing, Jiangsu, China  

Study leader's address:

87 Dingjiaqiao Road, Nanjing, Jiangsu, China  

申请注册联系人邮政编码:

Applicant postcode:

210009 

研究负责人邮政编码:

Study leader's postcode:

210009 

申请人所在单位:

东南大学附属中大医院 

Applicant's institution:

Department of Cardiology, Zhongda Hospital of Southeast University Medical School  

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 of Southeast University Medical School  

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 Road, 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

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

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 of Southeast University Medical School

Address:

87 Dingjiaqiao Road, Nanjing, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

急性心肌梗死 

Target disease:

acute myocardial infarction 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本课题拟探讨血红蛋白水平对急性ST段抬高型心肌梗死患者PCI术后预后的影响。探讨急性ST段抬高型心肌梗死患者理想的血红蛋白水平。为进一步优化心肌梗死治疗方案提供思路。 

Objectives of Study:

The purpose of this study is to investigate the effect of hemoglobin level on the prognosis of patients with acute ST segment elevation myocardial infarction after PCI. Objective to investigate the ideal hemoglobin level in patients with acute ST segment elevation myocardial infarction (AMI). The purpose of this study is to provide ideas for further optimizing the treatment of myocardial infarction. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

经临床确诊为急性ST抬高心肌梗死并行经皮冠状动脉介入治疗的病例。 

Inclusion criteria

Consecutive patients admitted to the hospital from June 2013 to April 2016, who were clinically diagnosed with acute ST elevation myocardial infarction, were treated with parallel percutaneous coronary intervention. 

排除标准:

近期(3个月)内有重大手术、外伤及出血史;抗凝和抗血小板治疗禁忌症;出血性脑血管意外或半年内有缺血性脑血管意外发生;存在出血性疾病或血小板减少;阿司匹林及造影剂过敏;严重的肝、肾功能损伤;恶性肿瘤;临床资料或者冠状动脉造影资料不全者。 

Exclusion criteria:

The recent (3 months) in major surgery, trauma and bleeding history; contraindications to anticoagulation and antiplatelet therapy; hemorrhagic cerebral vascular accident or within half a year have ischemic cerebrovascular accident; presence of hemorrhagic disease or thrombocytopenia; aspirin and contrast agent allergy; liver and kidney function damage; malignant tumor; clinical data coronary angiography or incomplete data. 

研究实施时间:

Study execute time:

From2017-07-01To 2017-12-01 

征募观察对象时间:

Recruiting time:

From2017-07-01To 2017-12-01 

干预措施:

Interventions:

组别:

低血红蛋白水平组

样本量:

130

Group:

Low hemoglobin level group

Sample size:

干预措施:

经临床确诊为急性ST抬高心肌梗死并行经皮冠状动脉介入治疗的病例。

干预措施代码:

Intervention:

Consecutive patients admitted to the hospital from June 2013 to April 2016, who were clinically diagnosed with acute ST elevation myocardial infarction, were treated with parallel percutaneous coronary intervention.

Intervention code:

组别:

中血红蛋白水平组

样本量:

130

Group:

Mid hemoglobin level group

Sample size:

干预措施:

经临床确诊为急性ST抬高心肌梗死并行经皮冠状动脉介入治疗的病例。

干预措施代码:

Intervention:

Consecutive patients admitted to the hospital from June 2013 to April 2016, who were clinically diagnosed with acute ST elevation myocardial infarction, were treated with parallel percutaneous coronary intervention.

Intervention code:

组别:

高血红蛋白水平组

样本量:

130

Group:

High hemoglobin level group

Sample size:

干预措施:

经临床确诊为急性ST抬高心肌梗死并行经皮冠状动脉介入治疗的病例。

干预措施代码:

Intervention:

Consecutive patients admitted to the hospital from June 2013 to April 2016, who were clinically diagnosed with acute ST elevation myocardial infarction, were treated with parallel percutaneous coronary intervention.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

东南大学附属中大医院 

单位级别:

三级医院 

Institution
hospital:

Zhongda Hospital of Southeast University Medical School  

Level of the institution:

tertiary hospital 

测量指标:

Outcomes:

指标中文名:

血红蛋白

指标类型:

主要指标 

Outcome:

hemoglobin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要不良心脑血管事件

指标类型:

主要指标 

Outcome:

Major Adverse Cardio Cerebrovascular Event

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):

连续选择于2013年6月至2016年4月入院的经临床确诊为急性ST抬高心肌梗死并行经皮冠状动脉介入治疗的病例。

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

Consecutive patients admitted to the hospital from June 2013 to April 2016, who were clinically diagnosed with acute ST elevation myocardial infarction, were treated with parallel percutaneous coronary intervention.

盲法:

Blinding:

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):

2018年7月通过临床试验公共管理平台ResMan

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

Open by ResMan in July 2018

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:

原始数据及病例记录表由东南大学附属中大医院心内科资料室数据库保存

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 of Southeast University Medical School

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-06-01
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