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A prospective and observational study of superselective adrenal artery embolization in the treatment of primary aldosteronism
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注册号:

Registration number:

ChiCTR2100047689 

最近更新日期:

Date of Last Refreshed on:

2021-06-22 

注册时间:

Date of Registration:

2021-06-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于真实世界的超选择性肾上腺动脉栓塞治疗原发性醛固酮增多症病例注册登记研究 

Public title:

A prospective and observational study of superselective adrenal artery embolization in the treatment of primary aldosteronism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于真实世界的超选择性肾上腺动脉栓塞治疗原发性醛固酮增多症病例注册登记研究 

Scientific title:

A prospective and observational study of superselective adrenal artery embolization in the treatment of primary aldosteronism 

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:

董一飞 

研究负责人:

董一飞 

Applicant:

Yi-Fei Dong 

Study leader:

Yi-Fei Dong 

申请注册联系人电话:

Applicant telephone:

+86 13576007061 

研究负责人电话:

Study leader's telephone:

+86 13576007061 

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:

yf_dong66@126.com 

研究负责人电子邮件:

Study leader's E-mail:

yf_dong66@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:

江西省南昌市东湖区明德路1号 

研究负责人通讯地址:

江西省南昌市东湖区明德路1号 

Applicant address:

1 Mingde Road, Donghu District, Nanchang, Jiangxi, China 

Study leader's address:

1 Mingde Road, Donghu District, Nanchang, Jiangxi, 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:

南昌大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Nanchang 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:

2021001 

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:

南昌大学第二附属医院医疗技术伦理委员会 

Name of the ethic committee:

Ethics Review Committee of the Second Affiliated Hospital of Nanchang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-01-25 

伦理委员会联系人:

南昌大学第二附属医院医疗技术伦理委员会 

Contact Name of the ethic committee:

Ethics Review Committee of the Second Affiliated Hospital of Nanchang University 

伦理委员会联系地址:

江西省南昌市东湖区明德路1号 

Contact Address of the ethic committee:

1 Mingde Road, Donghu District, Nanchang, Jiangxi, 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:

南昌大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Nanchang University 

研究实施负责(组长)单位地址:

江西省南昌市明德路1号 

Primary sponsor's address:

1 Mingde Road, Donghu District, Nanchang, Jiangxi, 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):

江西省

市(区县):

Country:

China

Province:

Jiangxi

City:

单位(医院):

南昌大学第二附属医院

具体地址:

江西省南昌市东湖区明德路1号

Institution
hospital:

The Second Affiliated Hospital of Nanchang University

Address:

1 Mingde Road, Donghu District, Nanchang

经费或物资来源:

申办方 

Source(s) of funding:

Sponsor 

研究疾病:

原发性醛固酮增多症 

Target disease:

Primary Aldosteronism 

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:

收集真实世界临床实践中接受超选择性肾上腺动脉栓塞治疗的原发性醛固酮增多症病例,通过观察性研究,评价超选择性肾上腺动脉栓塞治疗原发性醛固酮增多症的有效性及安全性。 

Objectives of Study:

To evaluate the efficacy and safety of super selective adrenal artery embolization (SAAE) for primary aldosteronism in a real-world setting by observating the cases treated with SAAE. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1、按照2016年国际内分泌学会的临床指南确诊为原发性醛固酮增多症; 2、年龄18~75岁,男女不限; 3、未服降压药时至少3次非同日诊室血压≥140/90mmHg,或者是24小时动态血压全天平均血压>130/80 mmHg或白天平均血压>135/85 mmHg; 4、分侧肾上腺静脉取血分型诊断为醛固酮瘤和/或特发性醛固酮增多症患者; 5、向患者及家属详细介绍当前所有治疗原发性醛固酮增多症的方法,其同意接受SAAE治疗。 

Inclusion criteria

1. Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines; 2. Aged 18-75 years males and females; 3. At least 3 non ambulatory office BP >=140 / 90 mmHg while not taking antihypertensive medication or if either the 24-h ambulatory BP average throughout the day is > 130 / 80 mmHg or the daytime average BP is > 135 / 85 mmHg; 4. Patients with a diagnosis of aldosteronoma and / or idiopathic aldosteronism; 5. All current treatments for primary aldosteronism were described in detail to patients and families, who consented to treatment with super selective adrenal artery embolization. 

排除标准:

1.直径大于2cm以上的腺瘤; 2.3月内有脑卒中、心肌梗死和血管内支架置入史; 3.肾功能不全,血肌酐>176μmol/L或估算的肾小球滤过率<45 mL/min/1.73 m2; 4.伴有其他严重的器质性疾病致使患者无法耐受SAAE治疗; 5.孕产妇; 6.严重对比剂过敏史。 

Exclusion criteria:

1. Adenomas greater than 2 cm in diameter; 2. History of stroke, myocardial infarction and endovascular stent placement within 3 months; 3. Renal insufficiency with blood creatinine > 176μMol / L or an estimated glomerular filtration rate < 45 ml / min / 1.73 m2; 4. Concomitant with other severe organic disease such that the patient was unable to tolerate SAAE treatment; 5. Maternal; 6. History of severe contrast allergy. 

研究实施时间:

Study execute time:

From2018-01-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

肾上腺动脉栓塞组

样本量:

250

Group:

SAAE Group

Sample size:

干预措施:

超选择性肾上腺动脉栓塞

干预措施代码:

Intervention:

super selective adrenal artery embolization

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江西省 

市(区县):

南昌市 

Country:

China 

Province:

Jiangxi Province 

City:

Nanchang City 

单位(医院):

南昌大学第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Nanchang University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

家庭血压

指标类型:

主要指标 

Outcome:

Home blood pressure

Type:

Primary indicator 

测量时间点:

1,3,6,12个月

测量方法:

电话随访

Measure time point of outcome:

the 1st, 3rd, 6th and 12th month

Measure method:

follow-up by telephone

指标中文名:

动态血压监测

指标类型:

主要指标 

Outcome:

ambulatory blood pressure monitoring

Type:

Primary indicator 

测量时间点:

1,3,6,12个月

测量方法:

门诊随访

Measure time point of outcome:

the 1st, 3rd, 6th and 12th month

Measure method:

follow-up by outpatient visits

指标中文名:

血钾浓度

指标类型:

主要指标 

Outcome:

Blood potassium concentration

Type:

Primary indicator 

测量时间点:

1,3,6,12个月

测量方法:

门诊随访

Measure time point of outcome:

the 1st, 3rd, 6th and 12th month

Measure method:

follow-up by outpatient visits

指标中文名:

血浆醛固酮浓度

指标类型:

主要指标 

Outcome:

Plasma aldosterone concentration

Type:

Primary indicator 

测量时间点:

1,3,6,12个月

测量方法:

门诊随访

Measure time point of outcome:

the 1st, 3rd, 6th and 12th month

Measure method:

follow-up by outpatient visits

指标中文名:

血浆肾素活性

指标类型:

主要指标 

Outcome:

Plasma renin activity

Type:

Primary indicator 

测量时间点:

1,3,6,12个月

测量方法:

门诊随访

Measure time point of outcome:

the 1st, 3rd, 6th and 12th month

Measure method:

follow-up by outpatient visits

指标中文名:

服用降压药物种类

指标类型:

主要指标 

Outcome:

Type of antihypertensive drugs

Type:

Primary indicator 

测量时间点:

0,1,3,6,12个月

测量方法:

电话/门诊随访

Measure time point of outcome:

the 0, 1st, 3rd, 6th and 12th month

Measure method:

follow-up by telephone or outpatient visits

指标中文名:

肾上腺CT平扫或增强

指标类型:

主要指标 

Outcome:

Plain or enhanced CT scan of adrenal gland

Type:

Primary indicator 

测量时间点:

1个月

测量方法:

门诊随访

Measure time point of outcome:

the 1st month

Measure method:

follow-up by outpatient visits

指标中文名:

治疗过程中以及整个研究期间发生的不良事件

指标类型:

主要指标 

Outcome:

Adverse events

Type:

Primary indicator 

测量时间点:

0,1,3,6,12个月

测量方法:

电话/门诊随访

Measure time point of outcome:

the 0, 1st, 3rd, 6th and 12th month

Measure method:

follow-up by telephone or outpatient visits

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:

标本中文名:

血压

组织:

Sample Name:

Blood pressure

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 75 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):

连续入组

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

Consecutive enrollment

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

申办方

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

Sponsor

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-06-22
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