NCT03778645

Brief Summary

Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Right adrenal vein catheterization is often difficult due to unfavorable anatomy of the vein including small vein size, short length, caudal direction for the transfemoral approach, and rare drainage to the accessory hepatic vein. All of these factors limit the widespread use of this approach. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

December 15, 2018

Last Update Submit

December 19, 2018

Conditions

HyperaldosteronismAngiography

Keywords

Adrenal venous samplingHyperaldosteronismAngiographyAntecubital approach

Outcome Measures

Primary Outcomes (1)

  • The success rate of bilateral adrenal sampling

    From January 1st 2012 to December 31st 2018

Secondary Outcomes (3)

  • The success rate of right adrenal sampling

    From January 1st 2012 to December 31st 2018

  • The success rate of left adrenal sampling

    From January 1st 2012 to December 31st 2018

  • The incidence of adrenal vein ruptures occurring during AVS

    From January 1st 2012 to December 31st 2018

Interventions

Adrenal Venous SamplingPROCEDURE

Adrenal Venous Sampling via an Antecubital Approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with primary aldosteronism underwent AVS via antecubital approach between January 1st 2012 and December 31st 2018 in medical centers (agreement of the principal investigator to participate to the AVSA) in China

You may qualify if:

  • Consent of the principal investigator to participate to the data collection of patients with primary aldosteronism underwent AVS via antecubital approach

You may not qualify if:

  • Refusal of the principal investigator to participate to the AVSA Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

The Eighth Affiliated Hospital of Sun Yat-sen University

Shenzhen, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Xi'an NO.3 Hospital

Xi’an, Shanxi, China

RECRUITING

The First Affiliated Hospital of Medical College of Shihezi Universtiy

Shihezi, Xinjiang, China

RECRUITING

Related Publications (1)

  • Dong H, Huang J, Zhang Y, Dong Y, Liu M, Yan Z, Li J, Chen Y, Zou Y, Wang J, Kang Y, Jiang Z, Song W, Zuo Y, Xiong H, Xu J, Jiang X. Adrenal Venous Sampling Via an Antecubital Approach in Primary Aldosteronism: A Multicenter Study. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e274-e279. doi: 10.1210/clinem/dgad433.

    PMID: 37466201DERIVED

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Xiongjing Jiang, MD

    Fuwai Hospital, National Center for Cardiovascular Disease

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiongjing Jiang, MD

CONTACT

+861088322385jxj103@hotmail.com

Hui Dong, MD

CONTACT

+861088322385donghui666@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 19, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)