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心脑血管疾病和相关疾病危险因素及干预研究(开滦研究)
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注册号:

Registration number:

ChiCTR-TNRC-11001489 

最近更新日期:

Date of Last Refreshed on:

2017-06-01 

注册时间:

Date of Registration:

2011-08-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

心脑血管疾病和相关疾病危险因素及干预研究(开滦研究) 

Public title:

Risk factors and intervention for cardiology, cerebrovascular and related disease (Kailuan Study) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心脑血管疾病和相关疾病危险因素及干预研究 

Scientific title:

Risk factors and intervention for cardiology, cerebrovascular and related disease 

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:

吴寿岭 

研究负责人:

吴寿岭 

Applicant:

Shouling Wu 

Study leader:

Shouling Wu 

申请注册联系人电话:

Applicant telephone:

+86 315 3025655 

研究负责人电话:

Study leader's telephone:

+86 315 3025655 

申请注册联系人传真 :

Applicant Fax:

+86 315 3025655 

研究负责人传真:

Study leader's fax:

+86 315 3025655 

申请注册联系人电子邮件:

Applicant E-mail:

drwusl@163.com 

研究负责人电子邮件:

Study leader's E-mail:

drwusl@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.klyy.com/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.klyy.com/ 

申请注册联系人通讯地址:

河北省唐山市新华东道57号 

研究负责人通讯地址:

河北省唐山市新华东道57号 

Applicant address:

57 East Xinhua Rd, Tangshan, Hebei, China 

Study leader's address:

57 East Xinhua Rd, Tangshan, Hebei, China 

申请注册联系人邮政编码:

Applicant postcode:

063000 

研究负责人邮政编码:

Study leader's postcode:

063000 

申请人所在单位:

开滦(集团)有限责任公司医院 

Applicant's institution:

Kailuan Hospital 

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:

2006-5 

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:

开滦(集团)有限责任公司医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Kailuan hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2006-01-05 

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:

开滦(集团)有限责任公司 

Primary sponsor:

Kailuan Hospital 

研究实施负责(组长)单位地址:

河北省唐山市新华东道70号 

Primary sponsor's address:

70 East Xinhua Rd, Tangshan, Hebei 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

开滦(集团)有限责任公司

具体地址:

河北省唐山市新华东道70号

Institution
hospital:

Kailuan Hospital

Address:

70 East Xinhua Rd, Tangshan, Hebei

经费或物资来源:

开滦(集团)有限责任公司 

Source(s) of funding:

Kailuan (Group) Co., Ltd. 

研究疾病:

心脑血管疾病和帕金森病、老年痴呆、肾脏病、睡眠障碍、糖尿病、自身免疫疾病、味觉/嗅觉功能障碍、癌症、呼吸系统疾病、肝脏疾病等其他非传染性疾病 

Target disease:

CVD, Parkinson, dementia, renal disorders, sleep disorders, diabetes, autoimmune diseases, taste/olfactory disorder, cancer, liver disease and respiratory disease 

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:

研究目的:

探讨心脑血管疾病和其他非传染性疾病的遗传和环境(例如空气污染、生活因素和压力)危险因素及干预研究。 

Objectives of Study:

To investigate the genetic and environmental (eg, air pollution, lifestyle factors and stress) risk factors and intervention for cardiovascular diseases, cerebrovascular diseases and other non-communicable diseases. 

药物成份或治疗方案详述:

螺内酯 醛固酮抑制剂 卡托普利 血管紧张素转换酶抑制剂 氢氯噻嗪 利尿剂 尼群地平 钙拮抗剂 

Description for medicine or protocol of treatment in detail:

spironolactone aldosterone Receptor Blocker captopril angiotensin-converting Enzyme Inhibitor nitrendipine calcium antagonist hydrochlorothiazide diuretic 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)年龄大等于18周岁;2)参加了开滦集团2006-2007年的健康查体;3)基础资料完整。 

Inclusion criteria

1. Individual aged 18 years and above; 2. Participated in health examination sponsored by Kailuan (Group) Co., Ltd. from June 2006 to September 2007; 3. Wwith completed baseline data 

排除标准:

1)主要基础资料缺失;2)不能按时完成随访的严重心脑血管疾病患者。 

Exclusion criteria:

1) baseline data missing; 2) patients with severe disease and can not be followed up. 

研究实施时间:

Study execute time:

From2006-01-01To 2016-01-01 

征募观察对象时间:

Recruiting time:

From2006-01-01To 2007-01-01 

干预措施:

Interventions:

组别:

A组

样本量:

1498

Group:

Group A

Sample size:

干预措施:

服用尼群地平5mg 2/日+卡托普利12.5mg 2/日

干预措施代码:

Intervention:

nitrendipine 5mg 2/day+captopril 12.5mg

Intervention code:

组别:

B组

样本量:

841

Group:

Group B

Sample size:

干预措施:

服用尼群地平 5mg 2/日+螺内酯 20mg 1/日

干预措施代码:

Intervention:

nitrendipine 5mg 2/day+spironolactone 20mg

Intervention code:

组别:

C组

样本量:

1300

Group:

Group C

Sample size:

干预措施:

服用氢氯噻嗪12.5mg 1/日+卡托普利12.5mg 2/日

干预措施代码:

Intervention:

hydrochlorothiazide 12.5mg 1/day+captopril 12.5mg

Intervention code:

组别:

D组

样本量:

1266

Group:

Group D

Sample size:

干预措施:

服用氢氯噻嗪12.5mg 1/日+螺内酯20mg 1/日

干预措施代码:

Intervention:

hydrochlorothiazide 12.5mg 1/day+captopril 12.5mg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

唐山 

Country:

China 

Province:

Hebei 

City:

Tangshan 

单位(医院):

开滦(集团)有限责任公司医院 

单位级别:

三级甲等 

Institution
hospital:

Kailuan hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

心脑血管疾病和相关疾病

指标类型:

主要指标 

Outcome:

Cardiovascular diseases, cerebrovascular diseases and other non-communicable diseases

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压、肥胖、血糖、血脂、炎症标志物、白蛋白、血清铁相关标志物、动脉硬化、其他非传染性疾病标志物(例如,踝臂指数)

指标类型:

次要指标 

Outcome:

Blood pressure, obesity, blood concentrations of glucose, lipid profiles, inflammation biomarkers, albumin, iron-related biomarkers, arterial stiffness, and other makers for these non-communicable diseases (e.g., ankle-brachial index)

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 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):

计算机软件

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

computer software

盲法:

研究对象 否

Blinding:

subjects not

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

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):

开滦(集团)有限责任公司医院

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

Kailuan hospital

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:

开滦(集团)有限责任公司医院

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

Kailuan hospital

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-08-24
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