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鸢尾素与卒中预后的关系分析
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注册号:

Registration number:

ChiCTR-OPC-17013501 

最近更新日期:

Date of Last Refreshed on:

2017-11-23 

注册时间:

Date of Registration:

2017-11-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

鸢尾素与卒中预后的关系分析 

Public title:

Irisin Is Associated with Functional Outcomes in the Ischemic Stroke  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

鸢尾素与卒中预后的关系分析 

Scientific title:

Irisin Is Associated with Functional Outcomes in the Ischemic Stroke  

研究课题代号(代码):

Study subject ID:

山东省科学技术发展项目(2015GGB14296)and 山东省重点实验室发展项目(2016GSF201229) 

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:

曾现伟 

研究负责人:

曾现伟 

Applicant:

Xian-Wei Zeng 

Study leader:

Xian-Wei Zeng 

申请注册联系人电话:

Applicant telephone:

+86 15201338315 

研究负责人电话:

Study leader's telephone:

+86 15201338315 

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:

wfzwxin@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wfzwxin@126.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:

山东省潍坊市虞河路2428 

研究负责人通讯地址:

山东省潍坊市虞河路2428 

Applicant address:

2428 Yuhe Road, Weifang, Shandong, China 

Study leader's address:

2428 Yuhe Road, Weifang, Shandong, China 

申请注册联系人邮政编码:

Applicant postcode:

261031 

研究负责人邮政编码:

Study leader's postcode:

261031 

申请人所在单位:

潍坊医学院附属医院 

Applicant's institution:

Affiliated Hospital of Weifang Medical College 

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:

2017-0017 

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:

潍坊医学院附属医院伦理委员会 

Name of the ethic committee:

Review board of the Affiliated Hospital of Weifang Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-22 

伦理委员会联系人:

邓爱军 

Contact Name of the ethic committee:

Ai-Jun Deng 

伦理委员会联系地址:

山东省潍坊市虞河路2428 

Contact Address of the ethic committee:

2428 Yuhe Road, Weifang, Shandong, China 

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:

潍坊医学院附属医院 

Primary sponsor:

Affiliated Hospital of Weifang Medical College 

研究实施负责(组长)单位地址:

山东省潍坊市虞河路2428 

Primary sponsor's address:

2428 Yuhe Road, Weifang, Shandong, 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):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

潍坊医科大学附属医院

具体地址:

山东省潍坊市虞河路2428

Institution
hospital:

Affiliated Hospital of Weifang Medical College

Address:

2428 Yuhe Road, Weifang, Shandong, China

经费或物资来源:

山东省科学技术发展项目(2015GGB14296)and 山东省重点实验室发展项目(2016GSF201229) 

Source(s) of funding:

Shandong Province Science and Technology Development Plan Project (No. 2015GGB14296); Shandong Province Key Research and Development Projects (No. 2016GSF20122) 

研究疾病:

急性缺血性脑卒中 

Target disease:

Ischemic Stroke 

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:

探索性研究/预试验 

Study phase:

研究目的:

研究急性缺血性脑卒中急性期血清鸢尾素浓度与卒中预后的关系 

Objectives of Study:

In this study, we investigate the short-term prognostic value of early measurement of irisin concentration in Chinese patients with Acute Ischemic Stroke (AIS). 

药物成份或治疗方案详述:

该研究不涉及药物治疗或者治疗方案 

Description for medicine or protocol of treatment in detail:

NA 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

初次发病24小时以内;符合WHO诊断标准;经过磁共振和(或者)CT确诊的急性缺血性脑卒中患者 

Inclusion criteria

AIS was defined according to the World Health Organization Multinational Monitoring of Trends and Determinants in Cardiovascular Disease (WHO-MONICA) criteria, and were verified by magnetic resonance imaging (MRI) reports performed within 24hours after admission. 

排除标准:

(1) 发病前诊断痴呆或认知障碍, 任何精神疾病病史和意识水平下降;(2) 恶性肿瘤、肝功能不全、肾功能不全、代谢异常 (不含糖尿病)、严重水肿和自身免疫性疾病;(3) 在发病前使用精神科药物;(4) 未经知情同意, 丢失血液样本, 或目前用于影响血清 irisin 水平的药物。 

Exclusion criteria:

(1) pre-stroke diagnosis of dementia or cognitive impairment, a history of any psychiatric illness and decreased level of consciousness; (2) malignant tumor, sarcopenia, liver insufficiency and renal insufficiency (creatinine >1.5 mg/dl), metabolic abnormalities (not included diabetes), severe edema and autoimmune diseases; (3) used psychotropic drugs prior to stroke onset; (4) without informed consents, lost blood samples, or current medications used that influence serum irisin levels. 

研究实施时间:

Study execute time:

From2017-12-16To 2019-06-15 

干预措施:

Interventions:

组别:

脑卒中组

样本量:

1000

Group:

Patients with Ischemic Stroke

Sample size:

干预措施:

无关于措施

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

潍坊医科大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Weifang Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国康复研究中心 

单位级别:

三甲甲等 

Institution
hospital:

Chinese Rehabilitation Research Center  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京天坛医院 

单位级别:

三甲甲等 

Institution
hospital:

Beijing tiantan hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

修正Rankin评分

指标类型:

主要指标 

Outcome:

modified Rankin Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

美国国立研究院卒中评分

指标类型:

次要指标 

Outcome:

NIHSS score

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:

标本中文名:

血清

组织:

Sample Name:

serum

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 25 years
最大 Max age 90 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):

非随机研究,序列研究

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

NA

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

采用网络平台

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

online site

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:

电子采集和管理系统

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

Electronic Data Capture, EDC),如ResMan即为一种

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-11-23
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