今天是:2020-09-23 星期三

吴业君医师:请在ResMan IPD平台资料上传处上传原始数据。 应用高分辨率磁共振血管壁成像评估颅内动脉粥样硬化性狭窄他汀类药物治疗效果的临床研究
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注册号:

Registration number:

ChiCTR2000034235 

最近更新日期:

Date of Last Refreshed on:

2020-06-29 

注册时间:

Date of Registration:

2020-06-29 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

吴业君医师:请在ResMan IPD平台资料上传处上传原始数据。 应用高分辨率磁共振血管壁成像评估颅内动脉粥样硬化性狭窄他汀类药物治疗效果的临床研究 

Public title:

Clinical research of using high resolution vessel wall magnetic resonance to evaluate the therapeutic effect of statins in intracranial atherosclerotic stenosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用高分辨率磁共振血管壁成像评估颅内动脉粥样硬化性狭窄他汀类药物治疗效果的临床及基础研究 

Scientific title:

Clinical and basic research of using high resolution vessel wall magnetic resonance to evaluate the therapeutic effect of statins in intracranial atherosclerotic stenosis 

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:

吴业君 

研究负责人:

吴业君 

Applicant:

Wu Yejun 

Study leader:

Wu Yejun 

申请注册联系人电话:

Applicant telephone:

+86 13591691080 

研究负责人电话:

Study leader's telephone:

+86 13591691080 

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:

naych1@163.com 

研究负责人电子邮件:

Study leader's E-mail:

naych1@163.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:

辽宁省沈阳市皇姑区崇山东路4号 

研究负责人通讯地址:

辽宁省沈阳市皇姑区崇山东路4号 

Applicant address:

4 Chongshan Road, Huanggu District, Shenyang, Liaoning, China  

Study leader's address:

4 Chongshan Road, Huanggu District, Shenyang, Liaoning, 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:

中国医科大学附属第四医院阅片会诊中心 

Applicant's institution:

Department of Radiology, the Fourth Affiliated Hospital of China Medical University 

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:

EC-2019-KS-016 

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:

中国医科大学附属第四医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Fourth Affiliated Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-26 

伦理委员会联系人:

金元哲 

Contact Name of the ethic committee:

Yuanzhe Jin 

伦理委员会联系地址:

辽宁省沈阳市皇姑区崇山东路4号 

Contact Address of the ethic committee:

4 Chongshan Road, Huanggu District, Shenyang, Liaoning, 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:

中国医科大学附属第四医院 

Primary sponsor:

The Fourth Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

辽宁省沈阳市皇姑区崇山东路4号 

Primary sponsor's address:

4 Chongshan Road, Huanggu District, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属第四医院

具体地址:

皇姑区崇山东路4号

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University

Address:

4 Chongshan Road, Huanggu District

经费或物资来源:

辽宁省自然科学基金资助项目 

Source(s) of funding:

Natural Science Foundation of Liaoning Province 

研究疾病:

颅内动脉粥样硬化 

Target disease:

intracranial atherosclerosis 

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:

其它 

Study phase:

N/A 

研究目的:

确定高分辨率磁共振血管壁成像在评价颅内动脉粥样硬化性血管狭窄他汀类药物治疗效果的的价值,指导临床个体化治疗和精准医疗,为临床对粥样硬化性狭窄患者的治疗提供可靠信息。 

Objectives of Study:

To determine the value of high-resolution vessel wall magnetic resonance angiography in evaluating the therapeutic effect of statins in intracranial atherosclerotic stenosis, to guide clinical individualized treatment and precision medicine, and to provide reliable information for clinical treatment of atherosclerotic stenosis patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1) 患者经临床诊断为颅内粥样硬化性动脉狭窄(需包含明确超声,CT或MRI检查结果); (2) 患者首次服用他汀类药物治疗粥样硬化性颅内动脉狭窄; (3) 年龄20~80岁; (4) 患者至少有1个或1个以上的粥样硬化危险因素:高血压、糖尿病、高血脂、吸烟、肥胖。 

Inclusion criteria

(1) the clinical diagnosis of patients with intracranial atherosclerotic arterial stenosis (should include ultrasound, CT or MRI results); (2) patients taking statins for the first time in treatment of atherosclerotic intracranial artery stenosis; (3) patients aged 20 to 80 years; (4) at least one or more than one of the atherosclerosis risk factors: hypertension, diabetes, hyperlipidemia, smoking, and obesity. 

排除标准:

(1) HR MRI检查禁忌症; (2) HRMRI检查序列不完整或图像质量不佳无法进行测量分析; (3) 孕妇及儿童。 

Exclusion criteria:

(1) HR MRI contrentions; (2) HRMRI sequences were incomplete or the image quality was poor and could not be measured and analyzed; (3) pregnant women and children. 

研究实施时间:

Study execute time:

From2019-03-27To 2022-07-01 

征募观察对象时间:

Recruiting time:

From2019-03-27To 2022-07-01 

干预措施:

Interventions:

组别:

试验组

样本量:

200

Group:

experimental group

Sample size:

干预措施:

阿托伐他汀钙20mg日一次口服

干预措施代码:

Intervention:

Atorvastatin calcium 20mg daily orally

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属第四医院 

单位级别:

公立三甲医院 

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

磁共振成像斑块负荷

指标类型:

主要指标 

Outcome:

plaque burden of MRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

磁共振成像斑块性质

指标类型:

主要指标 

Outcome:

character of plaque of MRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

磁共振成像狭窄率

指标类型:

主要指标 

Outcome:

stenosis rate of MRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂四项

指标类型:

主要指标 

Outcome:

TG CHOHDLLDL

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 80 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):

一个单臂,前瞻性观察性研究

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

a single-arm,prospective,observational study

盲法:

N/A

Blinding:

N/A

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):

临床随访结束后6个月公开,数据上传临床试验公共管理平台,http://www.medresman.org.cn。

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

6 months after the end of clinical follow-up, data were uploaded to Clinical Trial Management Public Platform, http://www.medresman.org.cn.

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:

病例记录表形式采集数据,数据管理利用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:

The data is collected in Case Record Form, and the data is managed by(Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-06-29
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