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中国经皮冠状动脉介入治疗后协作康复研究
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注册号:

Registration number:

ChiCTR-TRC-12002500 

最近更新日期:

Date of Last Refreshed on:

2015-09-05 

注册时间:

Date of Registration:

2012-09-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国经皮冠状动脉介入治疗后协作康复研究 

Public title:

Chinese collaborative study for rehabilitation after percutaneous coronary intervention 

注册题目简写:

中国PCI后康复研究 

English Acronym:

CSRPCI 

研究课题的正式科学名称:

中国经皮冠状动脉介入治疗后协作康复研究 

Scientific title:

Chinese collaborative study for rehabilitation after percutaneous 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:

李鹏虹 

研究负责人:

刘江生 

Applicant:

LI Peng-hong 

Study leader:

LIU Jiang-sheng 

申请注册联系人电话:

Applicant telephone:

+86 13328205383 

研究负责人电话:

Study leader's telephone:

+86 13960929021 

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:

phlee@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

xxgljs@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:

福州市北环中路147号 

研究负责人通讯地址:

福州市333邮政信箱 

Applicant address:

147 Middle Beihuan Road, Fuzhou, Fujian, China 

Study leader's address:

P.O.Box 333, Fuzhou 

申请注册联系人邮政编码:

Applicant postcode:

350003 

研究负责人邮政编码:

Study leader's postcode:

350003 

申请人所在单位:

福建省立医院北院(福建省老年医院) 

Applicant's institution:

North Hospital of Fujian Provincial Hospital (Fujian Provincial Geriatric 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:

心血管康复医学杂志社 

Primary sponsor:

Publishing House, Chinese Journal of Cardiovascular Rehabilitation Medicine 

研究实施负责(组长)单位地址:

福州市 333 邮政信箱 

Primary sponsor's address:

Publishing House, Chinese Journal of Cardiovascular Rehabilitation 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):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

心血管康复医学杂志社

具体地址:

福州市 333 邮政信箱

Institution
hospital:

Publishing House, Chinese Journal of Cardiovascular Rehabilitation Medicine

Address:

P.O.Box, 333, Fuzhou, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

冠状动脉硬化性心脏病 PCI 术后 

Target disease:

Coronary atherosclerotic heart disease after PCI 

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:

验证中国经皮冠状动脉介入治疗后康复程序的科学性,有效性和可行性, 探讨心脏康复医疗对PCI后患者病情(心绞痛、合并症等)、心功能、再狭窄、体力、生活质量的影响,及其机理。 

Objectives of Study:

To verify scientificity, validity and feasibility of Chinese rehabilitation program for patients after PCI, explore influence of cardiac rehabilitation medicine on patient's condition (angina, complication etc.), heart function, restenosis, physical strength and quality of life in patients after 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:

随机平行对照 

Study design:

Parallel 

纳入标准:

确诊冠心病,行急诊或择期PCI术后 

Inclusion criteria

The patients were definitely diagnosed as coronary heart disease, and after emergency or elective period PCI. 

排除标准:

1.心功能:左室射血分数(LVEF)≤35%;2,严重的心律失常;3,术后心绞痛未缓解;4,认知功能障碍;5,骨骼肌肉疾患不能运动者 

Exclusion criteria:

1.Heart function: Left ventricular ejection fraction (LVEF)<=35%; 2. Severe arrhythmia; 3. Angina didn't relieve after operation; 4. Cognitive dysfunction; 5. Patient cannot exercise because skeletal muscle disease. 

研究实施时间:

Study execute time:

From2010-08-01To 2015-08-01 

征募观察对象时间:

Recruiting time:

From2010-08-01To 2015-08-01 

干预措施:

Interventions:

组别:

康复组

样本量:

250

Group:

Rehabilitation group

Sample size:

干预措施:

康复措施

干预措施代码:

Intervention:

Rehabilitation management

Intervention code:

组别:

常规治疗组

样本量:

250

Group:

Routine treat control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建省立医院北院(福建省老年医院) 

单位级别:

三级 

Institution
hospital:

North Hospital of Fujian Provincial Hospital (Fujian Provincial Geriatric Hospital)  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

保定 

Country:

China 

Province:

Hebei 

City:

Baoding 

单位(医院):

中国人民解放军第252医院(全军老年心血管病中心 

单位级别:

三级 

Institution
hospital:

The PLA 252 Hospital (The PLA aged cardiovascular disease centre)  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changshsa 

单位(医院):

中国人民解放军第163医院 

单位级别:

三级 

Institution
hospital:

The PLA 163 Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

再窄率 %

指标类型:

主要指标 

Outcome:

Restenosis rate %

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动功能

指标类型:

主要指标 

Outcome:

Exercise function MET

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

《中国心血管病人生活质量评定问卷》评分

指标类型:

次要指标 

Outcome:

China questionnaire of quality of life in cardiaviscalar patient

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

附加指标 

Outcome:

Blood lipids

Type:

Additional 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:

血液

Sample Name:

Blood lipids

Tissue:

Blood lipids

人体标本去向

使用后销毁 

说明

使用后销毁

Fate of sample:

Destruction after use 

Note:

Destruction after use

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 43 years
最大 Max age 78 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

采用完全随机设计,用SPSS程序生成随机序列,由协作单位课题负责人操作。

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

The study was a completely randomized design, random sequence was generated using SPSS program and c

盲法:

Blinding:

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:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-09-16
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