Today is 2022-07-06

Effects of parenteral anticoagulation on outcomes in patients with acute myocardial infarction and high ischemic risk after coronary intervention: a multicenter, observational study
download

注册号:

Registration number:

ChiCTR2200057108 

最近更新日期:

Date of Last Refreshed on:

2022-02-28 

注册时间:

Date of Registration:

2022-02-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

冠脉介入术后胃肠外抗凝治疗对急性心肌梗死合并高缺血风险患者预后的影响:一项多中心、观察性研究 

Public title:

Effects of parenteral anticoagulation on outcomes in patients with acute myocardial infarction and high ischemic risk after coronary intervention: a multicenter, observational study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

冠脉介入术后胃肠外抗凝治疗对急性心肌梗死合并高缺血风险患者预后的影响 

Scientific title:

Effects of parenteral anticoagulation on outcomes in patients with acute myocardial infarction and high ischemic risk after coronary intervention 

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:

刘远辉 

研究负责人:

刘远辉 

Applicant:

Liu Yuanhui 

Study leader:

Liu Yuanhui 

申请注册联系人电话:

Applicant telephone:

13824440637 

研究负责人电话:

Study leader's telephone:

13824440637 

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:

liuyuanhui@gdph.org.cn 

研究负责人电子邮件:

Study leader's E-mail:

liuyuanhui@gdph.org.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:

广东省广州市越秀区中山二路 

研究负责人通讯地址:

广东省广州市越秀区中山二路 

Applicant address:

Yuexiu Strict, Guangzhou City,Guangdong Province 

Study leader's address:

Yuexiu Strict, Guangzhou City,Guangdong Province 

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:

广东省人民医院 

Applicant's institution:

Guangdong Provincial People's Hospital 

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:

KY-Q-2021-308-01 

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:

广东省人民医院伦理审查委员会 

Name of the ethic committee:

Ethics Review Committee of Guangdong Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-17 

伦理委员会联系人:

姚丽明 

Contact Name of the ethic committee:

Liming Yao 

伦理委员会联系地址:

广东省广州市越秀区中山二路 

Contact Address of the ethic committee:

Yuexiu Strict, Guangzhou City,Guangdong Province 

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:

广东省人民医院 

Primary sponsor:

Guangdong Provincial People's Hospital 

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路 

Primary sponsor's address:

Yuexiu Strict, Guangzhou City,Guangdong Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省人民医院

具体地址:

广东省广州市越秀区中山二路

Institution
hospital:

Guangdong Provincial People's Hospital

Address:

Yuexiu Strict, Guangzhou City,Guangdong Province

经费或物资来源:

NA 

Source(s) of funding:

NA 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

旨在探讨冠脉介入术后胃肠外抗凝治疗对急性心肌梗死合并高缺血风险患者预后的影响 

Objectives of Study:

To investigate the effect of parenteral anticoagulation therapy on the prognosis of patients with acute myocardial infarction complicated with high ischemic risk after coronary intervention 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)年龄≥18岁; (2)诊断为急性心肌梗死; (3)具有高缺血风险患者。 

Inclusion criteria

(1) Age ≥ 18 years old; (2) Diagnosed as acute myocardial infarction; (3) Patients with high ischemic risk. 

排除标准:

(1)存在其他已明确需抗凝治疗指征患者,如机械瓣膜植入术、肺栓塞、下肢静脉血栓、心房颤动、主动脉球囊反搏术等; (2)明确活动性主要出血; (3)存在服用双联抗血小板药物禁忌症; (4)行外科搭桥治疗的患者; (5)终末期肾衰竭或者肾移植术后; (6)入院24小时内死亡的患者; (7)存在恶性肿瘤,预期寿命不超过1年。 

Exclusion criteria:

(1) Patients with other indications for anticoagulation therapy, such as mechanical valve implantation, pulmonary embolism, lower extremity venous thrombosis, atrial fibrillation, aortic balloon counterpulsation, etc.; (2) Identify major active bleeding; (3) Contraindications to taking dual antiplatelet drugs; (4) Patients undergoing coronary artery bypass graft; (5) After end-stage renal failure or kidney transplantation; (6) Patients who died within 24 hours of admission; (7) There was a malignant tumor, and the life expectancy was not more than 1 year. 

研究实施时间:

Study execute time:

From2022-03-01To 2022-10-31 

征募观察对象时间:

Recruiting time:

From2022-03-15To 2022-10-01 

干预措施:

Interventions:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial People's Hospital  

Level of the institution:

tertiary first class 

测量指标:

Outcomes:

指标中文名:

主要复合不良心血管事件

指标类型:

主要指标 

Outcome:

major adverse cardiovascular events

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 18 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):

NA

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

NA

盲法:

Blinding:

是否共享原始数据:

IPD sharing

No

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):

NA

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

NA

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:

CRF和EDC

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

CRF and EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-02-28
return list