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翟正芹医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 经溶栓微导管血栓内溶栓对急性ST段抬高型心肌梗死高血栓负荷患者预后影响的多中心随机对照研究
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注册号:

Registration number:

ChiCTR2000033350 

最近更新日期:

Date of Last Refreshed on:

2020-05-29 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

翟正芹医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 经溶栓微导管血栓内溶栓对急性ST段抬高型心肌梗死高血栓负荷患者预后影响的多中心随机对照研究 

Public title:

Microatheter-targeted intracoronary thrombolysis in acute ST-elevation myocardial infarction patient with high thrombus burden: A multicenter and randomized clinical trial. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经溶栓微导管血栓内溶栓对急性ST段抬高型心肌梗死高血栓负荷患者预后影响的多中心随机对照研究 

Scientific title:

Microatheter-targeted intracoronary thrombolysis in acute ST-elevation myocardial infarction patient with high thrombus burden: A multicenter and randomized clinical trial. 

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:

翟正芹 

研究负责人:

郑金刚 

Applicant:

Zhengqin Zhai 

Study leader:

Jingang Zheng 

申请注册联系人电话:

Applicant telephone:

+86 18612511571 

研究负责人电话:

Study leader's telephone:

+86 18519805577 

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:

Zhengqin712@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

mdjingangzheng@163.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:

北京市朝阳区樱花园东街2号 

研究负责人通讯地址:

北京市朝阳区樱花园东街2号 

Applicant address:

2 Cherry Blossom Garden East Street, Chaoyang District, Beijing  

Study leader's address:

Cherry Blossom Garden East Street, Chaoyang District, Beijing  

申请注册联系人邮政编码:

Applicant postcode:

100029 

研究负责人邮政编码:

Study leader's postcode:

100029 

申请人所在单位:

中日友好医院 

Applicant's institution:

China-Japan Friendship Hospital 

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:

中日友好医院 

Primary sponsor:

China-Japan Friendship Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区樱花园东街2号 

Primary sponsor's address:

2 Cherry Blossom Garden East Street, Chaoyang District, Beijing  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院

具体地址:

朝阳区樱花园东街2号

Institution
hospital:

China-Japan Friendship Hospital

Address:

2 Cherry Blossom Garden East Street, Chaoyang District

经费或物资来源:

中华医学会心血管病学分会(CSC)临床研究专项基金 

Source(s) of funding:

CSC Clinical Research Funding 

研究疾病:

高血栓负荷的急性ST段抬高型心肌梗死 

Target disease:

STEMI patients with high thrombus burden 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

对高血栓负荷的STEMI患者,采用经新型溶栓微导管血栓内溶栓的治疗方法,与血栓抽吸组相比较,观察不同方法对患者心肌灌注和临床结局的影响。 

Objectives of Study:

To evaluate the efficacy, safety and feasibility of microcatheter-targeted intracoronary thrombolysis when compared with thrombus aspiration in patients with high thrombus burden when combined with primary percutaneous 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:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄在 18-80 岁之间(含 18 和 80 岁); (2)STEMI发病12小时以内; (3)造影后提示罪犯血管完全闭塞,且TIMI血栓分级≥3级。 

Inclusion criteria

1. Between 18 and 80 years old; 2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms; 3. Total occlusion of the culprit artery with high thrombus burden after guidewire passes the lesion (TIMI thrombus grade >= 3). 

排除标准:

(1)溶栓后补救PCI; (2)既往已行冠脉搭桥手术; (3)预期寿命<1年; (4)近6个月内有活动性出血、出血性疾病或已知有明显出血倾向; (5)严重肝或肾功能不全; (6)妊娠或哺乳期; (7)未控制的高血压(>180/100mmHg); (8)既往任何时候发生过出血性脑卒中,及3个月内发生过缺血性脑卒中; (9)心肺复苏术后; (10)不能知情同意或不能完成研究方案的所有治疗和随访评估; 

Exclusion criteria:

1. Rescue-PCI; 2. Previous coronary bypass grafting; 3. The predicted survival time less than 12 months due to non-cardiac diseases; 4. Active bleeding, bleeding diseases or known bleeding tendency within 6 months; 5. Sever hepatic or renal dysfunction; 6. Pregnancy or lactation; 7. Uncontrolled hypertension (>180/100mmHg); 8. Previous hemorrhagic stroke in any time or ischemic stroke within 3 months; 9. Cardiopulmonary resuscitation; 10. No informed consent or failure to complete all the treatment or follow-up according to the protocol. 

研究实施时间:

Study execute time:

From2021-01-01To 2025-12-31 

干预措施:

Interventions:

组别:

溶栓微导管组

样本量:

1000

Group:

Microcatheter-targeted thrombolysis group

Sample size:

干预措施:

经微导管血栓内溶栓

干预措施代码:

Intervention:

Microcatheter-targeted intracoronary thrombolysis

Intervention code:

组别:

血栓抽吸组

样本量:

1000

Group:

Thrombus aspiration group

Sample size:

干预措施:

常规冠脉内血栓抽吸

干预措施代码:

Intervention:

Conventional intracoronary thrombus aspiration

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津总医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Medical University General Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京同仁医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tongren Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

清华大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Tsinghua University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous region 

City:

 

单位(医院):

新疆生产建设兵团医院 

单位级别:

三级甲等 

Institution
hospital:

The Xinjiang Production and Construction Corps Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous region 

City:

 

单位(医院):

新疆医科大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second People's Hospital of Aksu  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjinag Uygur Autonomous Region 

City:

 

单位(医院):

新疆医科大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Xinjiang Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

新疆医科大学第五附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Fifth Affiliated Hospital of Xinjiang Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津泰达心血管病医院 

单位级别:

三级甲等 

Institution
hospital:

Teda International Cardiovascular Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

河南省胸科医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial Chest Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

新疆农四师医院 

单位级别:

二级甲等 

Institution
hospital:

Bingturn Sishi Hospital  

Level of the institution:

Secondary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

新疆伊犁哈萨克自治州友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Friendship Hospital of Ili Kazak Autonomous Prefecture  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

新疆维吾尔族自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

新疆生产建设兵团第二师库尔勒医院 

单位级别:

二级甲等 

Institution
hospital:

The Second Division Hospital of Xinjiang Production and Construction Corps  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

随访6个月要不良心血管事件发生率

指标类型:

主要指标 

Outcome:

Incidence of maior adverse cardiovascular events during six-month follow up

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后心肌呈色分级

指标类型:

次要指标 

Outcome:

Myocardial blush grade after procedure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后ST段回落

指标类型:

次要指标 

Outcome:

ST segment resolution after procedure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TIMI血流3级比例

指标类型:

次要指标 

Outcome:

Ratio of TIMI flow grade 3

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天随访内主要心血管事件发生率

指标类型:

次要指标 

Outcome:

The incidence of MACEs during 30-day follow up

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

随访30天卒中和严重出血事件发生率

指标类型:

主要指标 

Outcome:

The incidence of stroke or bleeding during 30-day follow up

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

随访3个月主要心血管事件发生率

指标类型:

次要指标 

Outcome:

The incidence of MACEs during three-month follow up

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

边支闭塞

指标类型:

次要指标 

Outcome:

Side-branch occlusion

Type:

Secondary 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

计算机随机数法

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

Random numbers generated by computer

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):

中日友好医院

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

China-Japan Friendship Hospital

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

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-29
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