中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR-OCH-13003951
最近更新日期： Date of Last Refreshed on：	2016-06-11 16:33:11
注册时间： Date of Registration：	2013-12-02 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	實時三維超聲心動圖在缺血性功能性關閉不全的二尖瓣單張適應的前瞻性臨床研究
Public title：	Mitral leaflet adaptation in ischemic functional regurgitation: A prospective clinical study using real-time 3-dimensional echocardiography
注册题目简写：
English Acronym：
研究课题的正式科学名称：	實時三維超聲心動圖在缺血性功能性關閉不全的二尖瓣單張適應的前瞻性臨床研究
Scientific title：	Mitral leaflet adaptation in ischemic functional regurgitation: A prospective clinical study using real-time 3-dimensional echocardiography
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：	Dr. Alex Pui Wai LEE	研究负责人：	Dr. Alex Pui Wai LEE
Applicant：	Dr. Alex Pui Wai LEE	Study leader：	Dr. Alex Pui Wai LEE
申请注册联系人电话： Applicant telephone：	+852 2632-3140	研究负责人电话： Study leader's telephone：	+852 2632-3140
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：	alexpwlee@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	alexpwlee@cuhk.edu.hk
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：	9/F, Clinical Sciences Building, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong	研究负责人通讯地址：	9/F, Clinical Sciences Building, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
Applicant address：	9/F, Clinical Sciences Building, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong	Study leader's address：	9/F, Clinical Sciences Building, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
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：	The Chinese University of Hong Kong
Applicant's institution：	The 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：	CRE-2012.058	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：	Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
Name of the ethic committee：	Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2012-03-13 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：

Research Grant Council

Primary sponsor：

Research Grant Council

研究实施负责（组长）单位地址：

Research Grant Council

Primary sponsor's address：

Research Grant Council

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 SAR	City：
单位(医院)：	The Chinese University of Hong Kong	具体地址：	The Chinese University of Hong Kong
Institution hospital：	The Chinese University of Hong Kong	Address：	The Chinese University of Hong Kong

经费或物资来源：

RGC-GRF

Source(s) of funding：

RGC-GRF

研究疾病：

Ischemic mitral regurgitation post first episode of myocardial infarction

Target disease：

Ischemic mitral regurgitation post first episode of myocardial infarction

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

1. To confirm the clinical occurence of mitral leaflet adaptation in IMR by prospectively following up 2 MI cohorts, one with IMR, another without, using RT3DE to track changes in mitral leaflet, annular and left ventricular geometry from the acute to chronic phase of the disease; 2. To define the natural history of mitral leaflet adaptation with regard to its incidence, onset timing, durability, and extent by following up the study population for 1 year; 3. To test the hypothesis that inadequate leaflet adaptive enlargement to compensate for leaflet tethering contributes to the development of IMR by prospectively comparing IMR + and IMR- groups; 4. To explore the interactions between adaptive structural alteration taking placing in the mitral leaflets, annulus, and left ventricle, and their relationships with the development of IMR; 5. To identify potential factor(s) including clinical characteristics, echo cardiographic feathers, and therapeutic measures that may affect the occurrence and degree of mitral leaflet adaptation.

Objectives of Study：

1. To confirm the clinical occurence of mitral leaflet adaptation in IMR by prospectively following up 2 MI cohorts, one with IMR, another without, using RT3DE to track changes in mitral leaflet, annular and left ventricular geometry from the acute to chronic phase of the disease; 2. To define the natural history of mitral leaflet adaptation with regard to its incidence, onset timing, durability, and extent by following up the study population for 1 year; 3. To test the hypothesis that inadequate leaflet adaptive enlargement to compensate for leaflet tethering contributes to the development of IMR by prospectively comparing IMR + and IMR- groups; 4. To explore the interactions between adaptive structural alteration taking placing in the mitral leaflets, annulus, and left ventricle, and their relationships with the development of IMR; 5. To identify potential factor(s) including clinical characteristics, echo cardiographic feathers, and therapeutic measures that may affect the occurrence and degree of mitral leaflet adaptation.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Prospectively enrolled patients hospitalized for first episode of acute MI.
1. Diagnosis of MI is based on cardiac pain, newly developed Q waves, ST elevation/depression on ECG, and typical rise and fall of cardiac biomarkers (Troponin and/or CPK);
2. Patient will receive standard management for acute MI including medications and/or revascularization according to physician discretion;
3. All MI patients meeting the inclusion criteria will have serial transthoracic echocardiographic study including 2D/3D/TDI within 72 hours, in 7-14 days, and at 1 month post-MI. Patients will be separated into 2 groups based on presence or absence of IMR at 1 month, as defined by color flow imaging. The rationale of using 1 month for group separation is to avoid inclusion of transient MR due to acute ischemia, and is based on accepted definition of IMR in large epidemiological studies (2-4), as well as the time frame of ML adaptation in animal studies (13, 14, 17);
4. Healthy controls with normal history, physical examination and echocardiography matched for age, gender and body surface area will be enrolled from the community.

Inclusion criteria

Prospectively enrolled patients hospitalized for first episode of acute MI.
1. Diagnosis of MI is based on cardiac pain, newly developed Q waves, ST elevation/depression on ECG, and typical rise and fall of cardiac biomarkers (Troponin and/or CPK);
2. Patient will receive standard management for acute MI including medications and/or revascularization according to physician discretion;
3. All MI patients meeting the inclusion criteria will have serial transthoracic echocardiographic study including 2D/3D/TDI within 72 hours, in 7-14 days, and at 1 month post-MI. Patients will be separated into 2 groups based on presence or absence of IMR at 1 month, as defined by color flow imaging. The rationale of using 1 month for group separation is to avoid inclusion of transient MR due to acute ischemia, and is based on accepted definition of IMR in large epidemiological studies (2-4), as well as the time frame of ML adaptation in animal studies (13, 14, 17);
4. Healthy controls with normal history, physical examination and echocardiography matched for age, gender and body surface area will be enrolled from the community.

排除标准：

Prior MI or known left ventricular dysfunction, previous cardiac surgery, papillary muscle rupture, MR due to primary organic valve disease, associated aortic valve or congenital heart disease, poor image quality, and atrial fibrillation.

Exclusion criteria：

Prior MI or known left ventricular dysfunction, previous cardiac surgery, papillary muscle rupture, MR due to primary organic valve disease, associated aortic valve or congenital heart disease, poor image quality, and atrial fibrillation.

研究实施时间：

Study execute time：

从 From 2013-02-18 00:00:00至 To 2016-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2013-02-18 00:00:00 至 To 2015-10-31 00:00:00

干预措施：

Interventions：

组别：	ischemic MR	样本量：	75
Group：	ischemic MR	Sample size：	75
干预措施：	NA	干预措施代码：
Intervention：	NA	Intervention code：

组别：	non-ischemic MR	样本量：	75
Group：	non-ischemic MR	Sample size：	75
干预措施：	NA	干预措施代码：
Intervention：	NA	Intervention code：

组别：	control	样本量：	50
Group：	control	Sample size：	50
干预措施：	NA	干预措施代码：
Intervention：	NA	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 SAR	City：
单位(医院)：	The Chinese University of Hong Kong	单位级别：	The Chinese University of Hong Kong
Institution hospital：	The Chinese University of Hong Kong	Level of the institution：	The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：	Mitral Regurgitation	指标类型：	主要指标
Outcome：	Mitral Regurgitation	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	symptoms	指标类型：	主要指标
Outcome：	symptoms	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	physicial examination	指标类型：	主要指标
Outcome：	physicial examination	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	ECG	指标类型：	主要指标
Outcome：	ECG	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	6 mins hall walk - secondary indicator	指标类型：	主要指标
Outcome：	6 mins hall walk - secondary indicator	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Treadmill exercise test - secondary indicator	指标类型：	主要指标
Outcome：	Treadmill exercise test - secondary indicator	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Blood test - secondary indicator	指标类型：	主要指标
Outcome：	Blood test - secondary indicato	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：	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	90	岁 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）：

not applicable

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

not applicable

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：
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
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）：	NA
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NA
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：	NA
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	NA
数据与安全监察委员会： Data and Safety Monitoring Committee：
注册人： Name of Registration：	2013-12-06 00:00:00