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急性高原病的预警及评价关键指标研究
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注册号:

Registration number:

ChiCTR-RCS-12002232 

最近更新日期:

Date of Last Refreshed on:

2015-08-17 

注册时间:

Date of Registration:

2012-05-31 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

急性高原病的预警及评价关键指标研究 

Public title:

Investigation on the key factors in precaution and evaluation on Acute Moutain Sickness 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

急进高原人群病理生理指标与急性高原病发病的相关性研究 

Scientific title:

Investigation on the relationship between the pathophysiological factors in human rushing into the plateau and the pathology of AMS 

研究课题代号(代码):

Study subject ID:

国家卫生部行业专项201002012 

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:

陈国柱 

研究负责人:

黄岚 

Applicant:

Chen Guozhu 

Study leader:

Huang Lan 

申请注册联系人电话:

Applicant telephone:

+86 13617686963 

研究负责人电话:

Study leader's telephone:

+86 13808398102 

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:

cgz112ny@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huanglan260@yahoo.com.cn 

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:

重庆市沙坪坝区新桥医院全军心血管病研究所 

研究负责人通讯地址:

重庆市沙坪坝区新桥医院全军心血管病研究所 

Applicant address:

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, China, 

Study leader's address:

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, 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:

重庆市沙坪坝区新桥医院全军心血管病研究所 

Applicant's institution:

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, China, 

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:

(2012)临审第(2012015)号 

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:

中国人民解放军第三军医大学第二附属医院伦理委员会 

Name of the ethic committee:

the ethics committee of the Xinqiao Hospital, Third Military Medical University, Chongqing, PRC 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-05-09 

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:

重庆市沙坪坝区新桥医院全军心血管病研究所 

Primary sponsor:

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, China 

研究实施负责(组长)单位地址:

重庆市沙坪坝区新桥医院全军心血管病研究所 

Primary sponsor's address:

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, 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):

重庆

市(区县):

沙坪坝区

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市沙坪坝区新桥医院

具体地址:

重庆市沙坪坝区新桥医院全军心血管病研究所

Institution
hospital:

Xinqiao Hospital, Third Military Medical University

Address:

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University, Chongqing, China

经费或物资来源:

国家卫生部行业专项(201002012) 

Source(s) of funding:

Special Health Research Project, the Ministry of Health of the People's Republic of China (201002012) 

研究疾病:

急性高原病 

Target disease:

acute mountain sickness 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

建立急性高原病患者数据库资料;描述急性高原病的人口学资料、发病症状、相关体征、实验室检查和检验,并探寻其与AMS发病的关系;探索急性高原病预警及评估关键指标;建立急性高原病预警模型或评价体系 

Objectives of Study:

To build a database of AMS patients, find the chracters of demography, clinical syndrome, lab test of AMS, and establish a evaluating system to diagnose AMS in the early stage. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1.急进高原健康成人,年龄18-60岁, 2.按AMS诊断标准诊断为AMS的病人 

Inclusion criteria

1. Healthy adults rushing into plateau, aged from 18 to 60; 2. Patients diagnosed by AMS criteria. 

排除标准:

近期(6月内)高原暴露史,有精神、神经系统疾病患者,依从性差。 

Exclusion criteria:

1. High altitude exposure history within past 6 months; 2. Patients with psychological or neurological disorder; 3. Patients with bad comp1iance. 

研究实施时间:

Study execute time:

From2011-05-31To 2013-12-31 

征募观察对象时间:

Recruiting time:

From2011-05-31To 2013-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

4000

Group:

trail group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

沙坪坝区 

Country:

China 

Province:

Chongqing 

City:

Shapingba district 

单位(医院):

新桥医院 

单位级别:

三级甲等 

Institution
hospital:

Xinqiao hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

青海 

市(区县):

格尔木市 

Country:

China 

Province:

Qinghai 

City:

Golmud 

单位(医院):

解放军第二十二医院 

单位级别:

二级甲等 

Institution
hospital:

NO.22 hospital of PLA  

Level of the institution:

Secondary A hospital 

国家:

中国 

省(直辖市):

青海 

市(区县):

西宁 

Country:

China 

Province:

Qinghai 

City:

Xining 

单位(医院):

解放军第四医院 

单位级别:

三级甲等 

Institution
hospital:

NO.4 hospital of PLA  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

青海 

市(区县):

格尔木市 

Country:

China 

Province:

Qinghai 

City:

Golmud 

单位(医院):

格尔木市人民医院 

单位级别:

三级乙等 

Institution
hospital:

People's hospital of Golmud  

Level of the institution:

Tertiary B hospital 

国家:

中国 

省(直辖市):

新疆 

市(区县):

叶城 

Country:

China 

Province:

Xinjiang 

City:

Yecheng 

单位(医院):

解放军第十八医院 

单位级别:

二级甲等 

Institution
hospital:

NO.18 hospital of PLA  

Level of the institution:

Secondary A hospital 

测量指标:

Outcomes:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血氧饱和度

指标类型:

主要指标 

Outcome:

oxygen saturation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

主要指标 

Outcome:

Heart 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:

心脏超声

指标类型:

主要指标 

Outcome:

UCG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

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:

血生化指标

指标类型:

主要指标 

Outcome:

blood biochmistry markers

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

其它实验室检测指标

指标类型:

主要指标 

Outcome:

other laboratory biomarker

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 years
最大 Max age 60 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):

方便选择

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

convenient selection

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):

重庆市沙坪坝区新桥医院全军心血管病研究所

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

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University

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:

重庆市沙坪坝区新桥医院全军心血管病研究所

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

Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Third Military Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-05-31
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