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利用組織多普勒超聲波, 對早期的右心室功能不全, 以及其對左心室功能的影響, 進行一系列的超聲波評估
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注册号：

Registration number：

 ChiCTR-ONRC-10000909 

最近更新日期：

Date of Last Refreshed on：

 2015-06-14 11:38:46 

注册时间：

Date of Registration：

 2010-06-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

利用組織多普勒超聲波, 對早期的右心室功能不全, 以及其對左心室功能的影響, 進行一系列的超聲波評估

Public title：

Serial Echocardiographic Assessment of Early Right Ventricular Dysfunction by Tissue Doppler Echocardiography & its Impact on Left Ventricular Function

注册题目简写：

English Acronym：

研究课题的正式科学名称：

利用組織多普勒超聲波, 對早期的右心室功能不全, 以及其對左心室功能的影響, 進行一系列的超聲波評估

Scientific title：

Serial Echocardiographic Assessment of Early Right Ventricular Dysfunction by Tissue Doppler Echocardiography & its Impact on Left Ventricular Function

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：

Cheuk Man Yu 

研究负责人：

Cheuk Man Yu 

Applicant：

Cheuk Man Yu 

Study leader：

Cheuk Man Yu 

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：

 poonsp@cuhk.edu.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_CCT00138

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_CCT00138

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：

PWH

Applicant's institution：

PWH

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：

PWH

Name of the ethic committee：

PWH

伦理委员会批准日期：

Date of approved by ethic committee：

 2006-02-07 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：

RGC funding

Primary sponsor：

RGC funding

研究实施负责（组长）单位地址：

Rm. 12A28, 12/F, Main Building, PWH

Primary sponsor's address：

Rm. 12A28, 12/F, Main Building, PWH

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

RGC funding for the study

Source(s) of funding：

RGC funding for the study

研究疾病：

Chronic obstructive pulmonary disease (COPD)  

Target disease：

Chronic obstructive pulmonary disease (COPD)

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：

 IV期临床试验 

Study phase：

4

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

Serial Echocardiographic Assessment of Early Right Ventricular Dysfunction by Tissue Doppler Echocardiography & its Impact on Left Ventricular Function.  

Objectives of Study：

Serial Echocardiographic Assessment of Early Right Ventricular Dysfunction by Tissue Doppler Echocardiography & its Impact on Left Ventricular Function.

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) COPD with history of hospitalization due to acute exacerbation within the past 3 months;
2) COPD who are dependent on assisted ventilation of any kind that may affect cardiac function;
3) Patients who have other interstitial lung disease, e.g. pneumoconiosis, bronchiectasis, alveolar fibrosis, etc;
4) Patients with other active lung pathologies, such as primary or secondary lung malignancies, pneumonia, active tuberculosis, pleural effusion, etc;
5) Patients with primary pulmonary hypertension;
6) Patients with secondary pulmonary hypertension other than due to COPD, such as thromboembolism;
7) Patients who known structural heart disease, such as coronary heart disease, left ventricular hypertrophy, significant valvular heart disease, cardiomyopathies, etc;
8) Patients with active cardiac arrhythmias such as atrial fibrillation;
9) Patients with active systemic illness or end-organ disease that may affect cardiac or pulmonary function, such as renal or liver failure;
10) Patients with disease with expected life expectancy <1 year, such as malignancies;
11) Patients who refuse to participate the study.

Exclusion criteria：

1) COPD with history of hospitalization due to acute exacerbation within the past 3 months;
2) COPD who are dependent on assisted ventilation of any kind that may affect cardiac function;
3) Patients who have other interstitial lung disease, e.g. pneumoconiosis, bronchiectasis, alveolar fibrosis, etc;
4) Patients with other active lung pathologies, such as primary or secondary lung malignancies, pneumonia, active tuberculosis, pleural effusion, etc;
5) Patients with primary pulmonary hypertension;
6) Patients with secondary pulmonary hypertension other than due to COPD, such as thromboembolism;
7) Patients who known structural heart disease, such as coronary heart disease, left ventricular hypertrophy, significant valvular heart disease, cardiomyopathies, etc;
8) Patients with active cardiac arrhythmias such as atrial fibrillation;
9) Patients with active systemic illness or end-organ disease that may affect cardiac or pulmonary function, such as renal or liver failure;
10) Patients with disease with expected life expectancy <1 year, such as malignancies;
11) Patients who refuse to participate the study.

研究实施时间：

Study execute time：

从 From 2006-03-27 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2006-03-27 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 75

Group：

1

Sample size：

干预措施：

Serial Echocardiographic examine the effect of Chronic Obstructive Pulmonary Disease of Early Right Ventricular Dysfunction; Duration of intervention: 5 years

干预措施代码：

Intervention：

Serial Echocardiographic examine the effect of Chronic Obstructive Pulmonary Disease of Early Right Ventricular Dysfunction; Duration of intervention: 5 years

Intervention code：

组别：

2

样本量：

 75

Group：

2

Sample size：

干预措施：

The goal of the proposed research project is to examine the effect of chronic obstructive pulmonary disease (COPD) on early occurrence of right ventricular [RV] dysfunction in both systole and diastole independent of development of hypertension, and its impact on left ventricular [LV] function. This can be achieved by the use of a sensitive echocardiographic tools, namely tissue Doppler imaging (TDI) and 3-dimensional echocardiography (3DE)

干预措施代码：

Intervention：

The goal of the proposed research project is to examine the effect of chronic obstructive pulmonary disease (COPD) on early occurrence of right ventricular [RV] dysfunction in both systole and diastole independent of development of hypertension, and its impact on left ventricular [LV] function. This can be achieved by the use of a sensitive echocardiographic tools, namely tissue Doppler imaging (TDI) and 3-dimensional echocardiography (3DE)

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)：

 PWH 

单位级别：

 PWH 

Institution
hospital：

PWH

Level of the institution：

PWH

测量指标：

Outcomes：

指标中文名：

Patients enrolled into the study will perform baseline assessment that include spirometry with DLCO, ECG, echo (with TDI and 3DE) examination, 6-Minute hall walk test, quality of life by St. Georges Respiratory Questionnaire, and blood test for neurohormones (B-type natriuretic peptides [BNP]), N-terminal Pro-BNP, epinephrine and norepinephrine). The investigation data collected from the Cross-sectional study will also be used as the baseline tests for the Prospective study. Patients will then

指标类型：

主要指标

Outcome：

Patients enrolled into the study will perform baseline assessment that include spirometry with DLCO, ECG, echo (with TDI and 3DE) examination, 6-Minute hall walk test, quality of life by St. Georges Respiratory Questionnaire, and blood test for neurohormones (B-type natriuretic peptides [BNP]), N-terminal Pro-BNP, epinephrine and norepinephrine). The investigation data collected from the Cross-sectional study will also be used as the baseline tests for the Prospective study. Patients will then

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Patients enrolled into the study will perform base

指标类型：

主要指标

Outcome：

Patients enrolled into the study will perform base

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Patients enrolled into the study will perform base

指标类型：

主要指标

Outcome：

Patients enrolled into the study will perform base

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Nil

指标类型：

次要指标

Outcome：

Nil

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Nil

指标类型：

次要指标

Outcome：

Nil

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Ni

指标类型：

次要指标

Outcome：

Ni

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：

暂停或中断

Suspending

年龄范围：

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

NA

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

NA

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）：

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：

  2015-06-14 11:38:46
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