急性冠脉综合征针刺全程干预治疗的临床研究

注册号:

Registration number:

AMCTR-IOR-20000318 

注册号获得时间:

Date of releasing the registration number:

2020/1/2 1:24:21 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

急性冠脉综合征针刺全程干预治疗的临床研究 

Public title:

Clinical study on the treatment of acute coronary syndrome with acupuncture 

研究课题的正式科学名称:

急性冠脉综合征针刺全程干预治疗的临床研究 

Scientific title:

Clinical study on the treatment of acute coronary syndrome with acupuncture 

研究课题代号(代码):

Study subject ID:

ZY(2018-2020)-FWTX-1011 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

王珂 

研究负责人:

周嘉 

Applicant:

Wang Ke 

Study leader:

Zhou Jia 

申请注册联系人电话:

Applicant telephone:

86+21-65161782-3136 

研究负责人电话:

Study leader's telephone:

86+21-65161782-3136 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

86+21-65164621 

申请注册联系人电子邮件:

Applicant E-mail:

wangke8430@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pdzhoujia@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:

上海市虹口区甘河路110号 

研究负责人通讯地址:

上海市虹口区甘河路110号 

Applicant address:

No. 110, Ganhe Rd., Hongkou District, Shanghai 

Study leader's address:

No. 110, Ganhe Rd., Hongkou District, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

200437 

研究负责人邮政编码:

Study leader's postcode:

200437 

申请人所在单位:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

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:

2019-084 

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-08 

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor's address:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address:

No. 110, Ganhe Rd., Hongkou District, Shanghai

经费或物资来源:

上海市卫生健康委员会 

Source(s) of funding:

Shanghai Municipal Health Commission 

研究疾病:

急性冠状动脉综合征 

Target disease:

Acute coronary syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

观察针刺全程干预治疗参与ACS急救的疗效,为针刺全程干预参与ACS急救的有效性提供可靠的科学依据。 

Objectives of Study:

To observe the effect of acupuncture intervention in the treatment of ACS. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 急性入院患者; 2. 年龄≥18周岁且≤80周岁,性别不限; 3. 符合急性ST段抬高心肌梗死(STEMI)和非ST段抬高心肌梗死(NSTEMI)诊断; 4. 符合并接受急诊PCI术; 5. 同意参加本研究并签署知情同意书者。 

Inclusion criteria

1. Emergency inpatient; 2. Aged 18 to 80 years, gender is not limited; 3. Diagnosis of acute st-segment elevation myocardial infarction (STEMI) and non-st-segment elevation myocardial infarction (NSTEMI); 4. Meet and accept emergency PCI; 5. Patients who agree to follow the trial protocol. 

排除标准:

1. 病情危重生命体征严重不平稳者; 2. 合并肝、肾、造血系统等严重损害者; 3. 研究对象本人因酗酒、智障等原因不能配合; 4. 无法完成PCI术的患者; 5. 合并严重心脏并发症,如心源性休克、恶性心律失常、急性心力衰竭等; 6. 针刺部位皮肤破损或感染等不适合针刺者; 7. 不同意在我院住院治疗而难以完成后续观察者; 8. 近期 4 周内作过手术及有出血倾向者。 

Exclusion criteria:

1. Patients who are critically ill with seriously unstable vital signs; 2. Combine severe damage such as liver, kidney, and hematopoietic system; 3. The subject himself could not cooperate due to alcoholism, mental retardation and other reasons; 4. Patients who are unable to complete PCI; 5. Complicated with serious cardiac complications, such as cardiogenic shock, malignant arrhythmia, acute heart failure, etc.; 6. Patients with skin damage or infection at the acupionts are not suitable for acupuncture; 7. Disagree with the hospitalization in our hospital and it is difficult to complete follow-up observers; 8. Patients who have had surgery within the last 4 weeks or have a tendency to bleed. 

研究实施时间:

Study execute time:

From2018-09-01To 2021-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

112

Group:

Control group

Sample size:

干预措施:

常规ACS治疗

干预措施代码:

Con

Intervention:

Conventional ACS treatment

Intervention code:

组别:

针刺组

样本量:

112

Group:

Acupunture group

Sample size:

干预措施:

常规ACS治疗的基础上加用针刺

干预措施代码:

Acu

Intervention:

Adding acupuncture to conventional ACS treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Third-grade class-A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长征医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Changzheng hospital  

Level of the institution:

Third-grade class-A hospital 

测量指标:

Outcomes:

指标中文名:

PCI术中慢血流发生率

指标类型:

主要指标 

Outcome:

slow blood flow in PCI operation

Type:

Primary indicator 

指标中文名:

心肌酶谱变化

指标类型:

主要指标 

Outcome:

Change of serum myocardial zymogram level

Type:

Primary indicator 

指标中文名:

重大心脑血管不良事件发生率

指标类型:

主要指标 

Outcome:

Major adverse cardiac/cerebrovascular event (MACCE) rate

Type:

Primary indicator 

指标中文名:

心脏磁共振扫描

指标类型:

次要指标 

Outcome:

Cardiac Magnetic Resonance

Type:

Secondary indicator 

指标中文名:

心电图检查

指标类型:

次要指标 

Outcome:

Electrocardiogram

Type:

Secondary indicator 

指标中文名:

心脏彩超检查

指标类型:

次要指标 

Outcome:

Cardiac Ultrasound Examination

Type:

Secondary indicator 

指标中文名:

NRS胸痛评分

指标类型:

次要指标 

Outcome:

NRS of chest pain

Type:

Secondary indicator 

指标中文名:

西雅图心绞痛评分

指标类型:

次要指标 

Outcome:

Seattle Angina Questionnaire

Type:

Secondary indicator 

指标中文名:

焦虑评分

指标类型:

次要指标 

Outcome:

Anxiety score

Type:

Secondary indicator 

指标中文名:

抑郁评分

指标类型:

次要指标 

Outcome:

Depression score

Type:

Secondary indicator 

指标中文名:

应激指标(皮质酮、肾上腺素、去甲肾上腺素)

指标类型:

次要指标 

Outcome:

Stress indicator (Corticosterone, Adrenaline, Norepinephrine)

Type:

Secondary indicator 

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

使用后保存 

说明

保存于生物样本库,保存时限1年

Fate of sample:

Preservation after use 

Note:

kept in the Biomedical Research Library at Lingnan Medical Research Center for a year

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 years

随机方法(请说明由何人用什么方法产生随机序列):

以中心为分层变量的分层区块随机化方法进行随机分组

性别:

男女均可

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

A center‐stratified, block randomisation method

Gender:

Both

盲法:

采用盲法评价,由不知分组情况的第三者进行疗效评价;资料总结阶段采用盲法统计分析,实行研究者、操作者、统计者三分离

Blinding:

Blind method for evaluators and statisticians

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

通过发表期刊文章公开原始数据

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

by publication

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

CRF表采集数据,数据电子存档管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

collect data by CRF, and manage data via computer

创建人:

Creater Name:

 2019-11-22
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