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明德醫院和香港中文大學共同合作，對缺血性心肌病進行體外震波治療的研究
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注册号：

Registration number：

 ChiCTR-TRC-10001035 

最近更新日期：

Date of Last Refreshed on：

 2015-06-27 12:34:45 

注册时间：

Date of Registration：

 2010-07-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

明德醫院和香港中文大學共同合作，對缺血性心肌病進行體外震波治療的研究

Public title：

MAtilda Hospital and Chinese University Shock Wave therapy for Ischemic Myocardium (MACUSWIM)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

明德醫院和香港中文大學共同合作，對缺血性心肌病進行體外震波治療的研究

Scientific title：

MAtilda Hospital and Chinese University Shock Wave therapy for Ischemic Myocardium (MACUSWIM)

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：

CUHK_CCT00251

申请注册联系人：

Cheuk Man Yu 

研究负责人：

Cheuk Man Yu / Sheung Poon 

Applicant：

Cheuk Man Yu 

Study leader：

Cheuk Man Yu / Sheung Poon 

申请注册联系人电话：

Applicant telephone：

 +852 2632 1752

研究负责人电话：

Study leader's
telephone：

+852 2632 1752

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：

 cmyu@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 poonsps@yahoo.com.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00251

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00251

申请注册联系人通讯地址：

Rm.12A28, 12/F, main building, PWH

研究负责人通讯地址：

Rm.12A28, 12/F, main building, PWH

Applicant address：

Rm.12A28, 12/F, main building, PWH

Study leader's address：

Rm.12A28, 12/F, main building, PWH

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：

Chinese University of Hong Kong

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 NA

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：

Chinese University of Hong Kong

Name of the ethic committee：

Chinese University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2008-04-07 00:00:00

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：

Chinese University of Hong Kong

Primary sponsor：

Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Chinese University of Hong Kong

Primary sponsor's address：

Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Chinese University of Hong Kong

具体地址：

Chinese University of Hong Kong

Institution
hospital：

Chinese University of Hong Kong

Address：

Chinese University of Hong Kong

经费或物资来源：

Chinese University of Hong Kong

Source(s) of funding：

Chinese University of Hong Kong

研究疾病：

Ischemic Cardiomyopathy  

Target disease：

Ischemic Cardiomyopathy

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

明德醫院和香港中文大學共同合作，對缺血性心肌病進行體外震波治療的研究  

Objectives of Study：

To assess MAtilda Hospital and Chinese University Shock Wave therapy for Ischemic Myocardium (MACUSWIM)

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Patient is male or female between 18 and 85 years of age on day of signing informed consent;
2. Contraception for female patients who are of reproductive potential: a femalepatient who is of reproductive potential agrees to remain abstinent or use (or havetheir partner use) 2 acceptable methods of birth control for the duration of the study.An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. Note: Female patients who have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use ofcontraceptives;
3. Patients with coronary angiography demonstrating coronary anatomy not amenable to revascularization or suitable for routine elective coronary artery bypass grafting with impaired LVEF < 40% and with substantial viable reversible myocardial ischemia in at least one vascular territory on MRI.

Exclusion criteria：

1. Patient is male or female between 18 and 85 years of age on day of signing informed consent;
2. Contraception for female patients who are of reproductive potential: a femalepatient who is of reproductive potential agrees to remain abstinent or use (or havetheir partner use) 2 acceptable methods of birth control for the duration of the study.An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. Note: Female patients who have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use ofcontraceptives;
3. Patients with coronary angiography demonstrating coronary anatomy not amenable to revascularization or suitable for routine elective coronary artery bypass grafting with impaired LVEF < 40% and with substantial viable reversible myocardial ischemia in at least one vascular territory on MRI.

研究实施时间：

Study execute time：

从 From 2008-02-04 00:00:00至 To 2012-07-21 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2008-02-04 00:00:00 至 To 2012-07-06 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 60

Group：

Two groups

Sample size：

干预措施：

Shock Wave therapy the patients with Ischemic Myocardium for 2 years

干预措施代码：

Intervention：

Shock Wave therapy for 2 years

Intervention code：

组别：

0

样本量：

 0

Group：

0

Sample size：

干预措施：

60 stable chronic angina patients with either coronary artery disease that is not amenable for revascularization or triple vessel coronary artery disease awaiting coronary artery bypass grafting will undergo baseline exercise testing, echocardiography, magnetic resonance imaging, and questionnaire assessment of symptoms.

干预措施代码：

Intervention：

60 stable chronic angina patients with either coronary artery disease that is not amenable for revascularization or triple vessel coronary artery disease awaiting coronary artery bypass grafting will undergo baseline exercise testing, echocardiography, magnetic resonance imaging, and questionnaire assessment of symptoms.

Intervention code：

组别：

0

样本量：

 0

Group：

0

Sample size：

干预措施：

After randomization, they will then undergo ultrasound shock wave therapy for 20 minutes, three times a week on either the first, fifth, and ninth week of the study or the 18th, 23rd, and 27th week of the study. Three blood tests will be taken during the first 12 hours after shock wave to monitor cardiac muscle enzyme and growth factor enzymes.

干预措施代码：

Intervention：

After randomization, they will then undergo ultrasound shock wave therapy for 20 minutes, three times a week on either the first, fifth, and ninth week of the study or the 18th, 23rd, and 27th week of the study. Three blood tests will be taken during the first 12 hours after shock wave to monitor cardiac muscle enzyme and growth factor enzymes.

Intervention code：

组别：

0

样本量：

 0

Group：

0

Sample size：

干预措施：

MRI heart, Exercise testing, and echocardiography would be performed at 6 months and coronary artery bypass grafting would be performed at 6 months. Follow up questionnaire and clinical assessment would be performed at 6 and 12 months FU. Patients randomized to non treatment arm will undergo MRI, exercise tests, questionnaires and echocardiography but will not attend for shock wave therapy.

干预措施代码：

Intervention：

MRI heart, Exercise testing, and echocardiography would be performed at 6 months and coronary artery bypass grafting would be performed at 6 months. Follow up questionnaire and clinical assessment would be performed at 6 and 12 months FU. Patients randomized to non treatment arm will undergo MRI, exercise tests, questionnaires and echocardiography but will not attend for shock wave therapy.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 CUHK 

单位级别：

 CUHK 

Institution
hospital：

CUHK

Level of the institution：

CUHK

测量指标：

Outcomes：

指标中文名：

Improved Exercise duration on standard Bruce Protocol Exercise test

指标类型：

主要指标

Outcome：

Improved Exercise duration on standard Bruce Protocol Exercise test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Improved angina frequency.

指标类型：

主要指标

Outcome：

Improved angina frequency.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Improved CCS angina grade.

指标类型：

次要指标

Outcome：

Improved CCS angina grade.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Improved 6 minute walk.

指标类型：

次要指标

Outcome：

Improved 6 minute walk.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Improved SF-36.

指标类型：

次要指标

Outcome：

Improved SF-36.

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 85 岁 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）：

RCT

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

random number table

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

: Open label

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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：

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-06-27 12:34:45
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