ART疗法与脂质异常及心血管风险

注册号:

Registration number:

ChiCTR2200059861 

最近更新日期:

Date of Last Refreshed on:

2023-03-11 22:34:16 

注册时间:

Date of Registration:

2022-05-13 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

ART疗法与脂质异常及心血管风险

Public title:

Art therapy and lipid abnormalities and cardiovascular risk

注册题目简写:

English Acronym:

研究课题的正式科学名称:

ART疗法与脂质异常

Scientific title:

Art therapy and lipid abnormalities

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:

刘胜囡 

研究负责人:

万静 

Applicant:

Shengnan Liu 

Study leader:

Jing Wan 

申请注册联系人电话:

Applicant telephone:

+86 15516860051

研究负责人电话:

Study leader's
telephone:

+86 18971656126

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:

2020283030101@whu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

wanjing_zn@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:

湖北省武汉市武昌区东湖路169号

研究负责人通讯地址:

湖北省武汉市武昌区东湖路169号

Applicant address:

169 Donghu Road, Wuchang District, Wuhan, Hubei

Study leader's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei

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:

武汉大学中南医院

Applicant's institution:

Zhongnan Hospital of Wuhan University

研究负责人所在单位:

武汉大学中南医院

Affiliation of the Leader:

Zhongnan Hospital of Wuhan University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

科伦[2022122K]

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:

武汉大学中南医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Zhongnan Hospital of Wuhan University

伦理委员会批准日期:

Date of approved by ethic committee:

2022-06-13 00:00:00

伦理委员会联系人:

郑磊

Contact Name of the ethic committee:

Lei Zheng

伦理委员会联系地址:

湖北省武汉市武昌区东湖路169号

Contact Address of the ethic committee:

169 Donghu Road, Wuchang District, Wuhan, Hubei

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:

武汉大学中南医院

Primary sponsor:

Zhongnan Hospital of Wuhan University

研究实施负责(组长)单位地址:

湖北省武汉市武昌区东湖路169号

Primary sponsor's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院

具体地址:

湖北省武汉市武昌区东湖路169号

Institution
hospital:

Zhongnan Hospital of Wuhan University

Address:

169 Donghu Road, Wuchang District, Wuhan, Hubei

经费或物资来源:

武汉大学中南医院

Source(s) of funding:

Zhongnan Hospital of Wuhan University

研究疾病:

艾滋病  

Target disease:

AIDS

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

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

分析HIV/AIDS患者疗效及其远期预后,并对相关心血管并发症做初步探讨与论述。  

Objectives of Study:

To analyze the curative effect and long-term prognosis of HIV / AIDS patients, and to make a preliminary discussion and Discussion on the related cardiovascular complications.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1. 患者有严重的心脑血管等疾病,濒临死亡者;
2. 严重精神疾病患者;
3. 资料不全影响判断者。

Exclusion criteria:

1. The patient has serious cardiovascular and cerebrovascular diseases and is on the verge of death;
2. Patients with severe mental illness;
3. Incomplete information affects the judge.

研究实施时间:

Study execute time:

From 2022-05-01 00:00:00 To 2022-08-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-05-01 00:00:00 To 2022-08-01 00:00:00

干预措施:

Interventions:

组别:

实验组

样本量:

300

Group:

Experimental group

Sample size:

干预措施:

ART

干预措施代码:

Intervention:

ART

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院 

单位级别:

三甲 

Institution
hospital:

Zhongnan Hospital of Wuhan University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

血脂

指标类型:

主要指标

Outcome:

Blood lipid index

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗逆转录病毒药物应用以及降脂药物应用情况

指标类型:

主要指标

Outcome:

Use of antiretrovirals and lipid-lowering drugs

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 85 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):

随机序列表

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

Random sequence

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

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):

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-05-13 12:02:20