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远程缺血适应对阵发性心房颤动患者心房颤动负荷的影响
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注册号:

Registration number:

ChiCTR-IOR-17012666 

最近更新日期:

Date of Last Refreshed on:

2017-09-14 

注册时间:

Date of Registration:

2017-09-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

远程缺血适应对阵发性心房颤动患者心房颤动负荷的影响 

Public title:

Effects of remote ischemic conditioning on atrial fibrillation burden in patients with paroxysmal atrial fibrillation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

远程缺血适应对阵发性心房颤动患者心房颤动负荷的影响 

Scientific title:

Effects of remote ischemic conditioning on atrial fibrillation burden in patients with paroxysmal atrial fibrillation 

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:

陈龙 

研究负责人:

陈龙 

Applicant:

Long Chen 

Study leader:

Long Chen 

申请注册联系人电话:

Applicant telephone:

+86 13851638480 

研究负责人电话:

Study leader's telephone:

+86 13851638480 

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:

longchen.crown@163.com 

研究负责人电子邮件:

Study leader's E-mail:

longchen.crown@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:

江苏省南京市鼓楼区丁家桥87号 

研究负责人通讯地址:

江苏省南京市鼓楼区丁家桥87号 

Applicant address:

87 Dingjia Qiao, Gulou District, Nanjing, China 

Study leader's address:

87 Dingjia Qiao, Gulou District, Nanjing, China 

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:

东南大学附属中大医院 

Applicant's institution:

Zhongda Hospital, School of Medicine, Southeast University 

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:

2017ZDSYLL043-P01 

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:

东南大学附属中大医院临床研究伦理委员会 

Name of the ethic committee:

IEC for Clinical Research of Zhongda Hospital, Affiliated to Southeast University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-06-13 

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:

东南大学附属中大医院 

Primary sponsor:

Zhongda Hospital, School of Medicine, Southeast University 

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区丁家桥87号 

Primary sponsor's address:

87 Dingjia Qiao, Gulou District, Nanjing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

东南大学附属中大医院

具体地址:

江苏省南京市鼓楼区丁家桥87号

Institution
hospital:

Zhongda Hospital, School of Medicine, Southeast University

Address:

87 Dingjia Qiao, Gulou District, Nanjing, China

经费或物资来源:

我院心内科赞助 

Source(s) of funding:

sponsored by department of cardiology,Zhongda Hospital 

研究疾病:

心房颤动 

Target disease:

atrial fibrillation 

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:

主要目的:12周远程缺血适应对阵发性房颤患者房颤负荷的影响。 

Objectives of Study:

The main objective of this study is to explore the effects of remote ischemic conditioning on atrial fibrillation burden for 12 weeks.  

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:

年龄≥18岁且≤75岁的男性或女性;能够理解并签署知情同意书;在筛选前3个月以上植入了具有房颤检测功能的双腔起搏器;筛选前的最后一次起搏器程控示房颤的负荷≥1%且小于等于70%,并且筛选期(4周)后随机化前的程控示房颤的负荷≥2%且小于等于70%;妊娠期女性应同意在试验期及试验结束后1周内采取有效的避孕措施。 

Inclusion criteria

1. patients between the age of 18 and 75 years old who can understand and sign informed consent; 2. have implanted dual-chamber pacemaker with function of detecting AF more than 3 months before recruitment; 3. the last pacemaker's progamming shows atrial fibrillation burden between 1% and 70% before recruitment and the AF burden between 2% and 70% before randomization; 4. Pregnant women should agree to take effective contraceptives within and 1 week after the trial. 

排除标准:

持续性或永久性房颤;既往有房扑或房速病史(已成功消融者除外);因可逆原因导致的房颤,包括但不限于:甲状腺功能亢进、心包炎、心肌炎或肺动脉栓塞等;永久起搏器和/或起搏器电极导线功能障碍的;近期内拟行永久起搏器更换的;近3月内发生了急性心肌梗死、不稳定性心绞痛、冠脉支架植入术或冠脉搭桥手术;有严重的心脏瓣膜病(中度以上的狭窄或关闭不全);近3月内发生了卒中;近3月内行心律失常射频消融的;孕期和哺乳期女性;近30天内或可能将在试验期内参加其他临床试验的;其他研究者认为不适合参加本试验的情况。 

Exclusion criteria:

1. patients with persistent or permanent AF; 2. history of atrial flutter or atrial tachycardia or valvular heart disease; 3. reversible AF caused by hyperthyroidism pericarditis myocarditis pulmonary embolism et al; 4. pacemaker malfunction or pacemaker replacement recently; 5. ACS or cardiac stent implantation or stroke or radiofrequency catheter ablation within 3 months; 6. Pregnant or lactating women; 7. have participate in other studies within 30 days or will participate in experiment period; 8. other situations thought not appropriate for the study. 

研究实施时间:

Study execute time:

From2017-08-01To 2018-08-01 

征募观察对象时间:

Recruiting time:

From2017-09-01To 2018-06-30 

干预措施:

Interventions:

组别:

RIC组

样本量:

33

Group:

RIC group

Sample size:

干预措施:

远端缺血适应

干预措施代码:

Intervention:

remote ischemia conditioning

Intervention code:

组别:

对照组

样本量:

33

Group:

control group

Sample size:

干预措施:

不处理

干预措施代码:

Intervention:

no interventions

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

东南大学附属中大医院 

单位级别:

三级甲等医院 

Institution
hospital:

Zhongda Hospital, School of Medicine, Southeast University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

房颤负荷;生活质量

指标类型:

主要指标 

Outcome:

AF burden; quality of life

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:

心电数据

组织:

Sample Name:

electrocardiographic

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 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):

随机数字表法(余金波)

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

random number table(Jinbo Yu)

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

否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):

在中国临床试验注册中心公布,网址为http://www.chictr.org.cn/,时间在试验完成后

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

we will share the study data at http://www.chictr.org.cn/ after the study finished

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:

数据采集将按照预先设计好的数据表格将数据录入Excel表格;数据有专人管理,及时更新及备份。

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

Data will be entered into excel for collection according to pre-designed data form. The data will be updated and backed up by fixed doctor.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-09-14
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