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: |
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English Acronym: |
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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: |
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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): |
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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 |
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Applicant's institution: |
Affiliated Hospital of Weifang Medical College |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Review board of the Affiliated Hospital of Weifang Medical College |
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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 |
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Contact Name of the ethic committee: |
Ai-Jun Deng |
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伦理委员会联系地址: |
山东省潍坊市虞河路2428 |
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Contact Address of the ethic committee: |
2428 Yuhe Road, Weifang, Shandong, China |
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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 |
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Primary sponsor: |
Affiliated Hospital of Weifang Medical College |
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研究实施负责(组长)单位地址: |
山东省潍坊市虞河路2428 |
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Primary sponsor's address: |
2428 Yuhe Road, Weifang, Shandong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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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) |
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Source(s) of funding: |
Shandong Province Science and Technology Development Plan Project (No. 2015GGB14296); Shandong Province Key Research and Development Projects (No. 2016GSF20122) |
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研究疾病: |
急性缺血性脑卒中 |
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Target disease: |
Ischemic Stroke |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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 |
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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). |
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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 |
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Description for medicine or protocol of treatment in detail: |
NA |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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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 |
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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. |
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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。 |
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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: |
从From2017-12-16至To 2019-06-15 |
征募观察对象时间: Recruiting time: |
从From2017-12-16至To 2018-12-15 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
NA |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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 |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |