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Study on Clinical, pathological and TCM Syndromes of IgA Nephropathy with malignant Hypertension
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注册号:

Registration number:

ChiCTR2200055933 

最近更新日期:

Date of Last Refreshed on:

2022-01-26 

注册时间:

Date of Registration:

2022-01-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

伴恶性高血压IgA肾病临床、病理及中医证候特征研究 

Public title:

Study on Clinical, pathological and TCM Syndromes of IgA Nephropathy with malignant Hypertension 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

伴恶性高血压IgA肾病临床、病理及中医证候特征研究 

Scientific title:

Study on Clinical, pathological and TCM Syndromes of IgA Nephropathy with malignant Hypertension 

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:

ChiMCTR2200005559 

申请注册联系人:

柯江华 

研究负责人:

柯江华 

Applicant:

kejianghua 

Study leader:

kejianghua 

申请注册联系人电话:

Applicant telephone:

19860782356 

研究负责人电话:

Study leader's telephone:

19860782356 

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:

1585827227@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1585827227@qq.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:

北京市海淀区复兴路28号院东病房楼 

研究负责人通讯地址:

北京市海淀区复兴路28号院东病房楼 

Applicant address:

Hospital East Ward Building, No.28 Fuxing Road, Haidian District, Beijing 

Study leader's address:

Hospital East Ward Building, No.28 Fuxing Road, Haidian District, Beijing 

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:

中国人民解放军总医院 

Applicant's institution:

Chinese PLA General Hosptial 

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:

S2021-165-01 

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:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Chinese PLA General Hosptial 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-04-16 

伦理委员会联系人:

曹江 

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:

中国人民解放军总医院 

Primary sponsor:

Chinese PLA General Hosptial 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

No.28 Fuxing Road, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国人民解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Chinese PLA General Hosptial

Address:

Chinese PLA General Hosptial

经费或物资来源:

北京市科技计划课题 

Source(s) of funding:

Beijing Science and Technology Planning Project 

研究疾病:

IgA肾病,恶性高血压 

Target disease:

IgAN,malignant hypertension 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

分析IgA肾病患者发生恶性高血压的中西医相关因素,探索其中医病机。 

Objectives of Study:

To analyze the related factors of traditional Chinese and Western medicine in malignant hypertension in patients with IgA nephropathy and explore its TCM pathogenesis.  

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:

纳入标准(1)本研究经解放军总医院第一医学中心伦理委员会批准(伦理批件号:S2021-165-01),回顾性纳入的患者免签知情同意,前瞻性纳入的患者均自愿参加本研究并签署知情同意书。(2)2013年以后在解放军总医院第一医学中心肾脏病医学部,经肾穿刺活检确诊的原发性IgA肾病患者。(3)肾穿刺住院诊断伴恶性高血压[10],即血压显著升高,通常>200/120 mmHg,同时可伴有显著双侧视网膜病变(火焰状出血、棉絮斑或视乳头水肿)。(4)肾穿刺活检时年龄18岁以上(含18岁),性别不限;(5)有肾穿刺活检前后7日内中医调查问卷。 

Inclusion criteria

Inclusion criteria (1) this study was approved by the ethics committee of the first medical center of the PLA General Hospital (ethics approval No.: s2021-165-01). The retrospective patients were exempted from signing informed consent, and the prospective patients voluntarily participated in this study and signed informed consent. (2) After 2013, patients with primary IgA nephropathy diagnosed by renal biopsy in the Department of Nephrology of the first medical center of the PLA General Hospital. (3) In hospital diagnosis of renal puncture with malignant hypertension [10], that is, the blood pressure is significantly elevated, usually > 200 / 120mmhg, and can be accompanied by significant bilateral retinopathy (flame hemorrhage, cotton wool spots or optic papilledema). (4) The age of renal biopsy was over 18 years old (including 18 years old), regardless of gender; (5) There was a questionnaire of traditional Chinese medicine within 7 days before and after renal biopsy.  

排除标准:

排除标准:(1)可评价的肾小球数少于8个;(2)紫癜性肾炎、狼疮性肾炎、乙型肝炎等继发性IgA肾病;(3)合并膜性肾病等其他肾脏疾病;(4)合并有糖尿病、结缔组织病等系统性疾病;(5)病历资料不完整。 

Exclusion criteria:

Exclusion criteria: (1) the number of evaluable glomeruli was less than 8; (2) Secondary IgA nephropathy such as purpura nephritis, lupus nephritis and hepatitis B; (3) Other renal diseases such as membranous nephropathy; (4) combined with diabetes, connective tissue disease and other systemic diseases. (5) The medical records are incomplete.  

研究实施时间:

Study execute time:

From2022-01-12To 2023-04-16 

征募观察对象时间:

Recruiting time:

From2022-01-12To 2023-04-16 

干预措施:

Interventions:

组别:

2

样本量:

102

Group:

two

Sample size:

干预措施:

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):

北京 

市(区县):

海淀区 

Country:

China 

Province:

beijing 

City:

Haidian District 

单位(医院):

PLA General Hospital  

单位级别:

3甲 

Institution
hospital:

PLA General Hospital  

Level of the institution:

3A hospital 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

no

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:

组织:

Sample Name:

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 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):

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

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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):

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

NO

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:

NO

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

no

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-01-26
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