Adrenal Venous Sampling Via an Antecubital Approach | NCT03778645

Studies
Adrenal Venous Sampling Via an Antecubital Approach

NCT03778645

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Dec 21, 2018Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Hyperaldosteronism
Angiography

Interventions

Adrenal Venous Sampling

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Dec 15, 2018

First Submission Date that Met QC Criteria

Dec 15, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2018

Last Update Posted Date

Dec 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiongjing Jiang, Professor, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Primary aldosteronism (PA) is recognized as the most common cause of secondary hypertension, with a prevalence of approximately 10% among unselected hypertensive populations. Subtype diagnosis is crucial because unilateral primary aldosteronism can be treated by laparoscopic adrenalectomy or open surgery, which may result in a cure or significant improvement of blood pressure, thus decreases the incidence of cardio-cerebrovascular complications. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012 at the Fuwai Hospital. So far, there have been more than fifteen hospitals to have some experience on AVS via antecubital approach with investigators' helps. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adrenal Venous Sampling	Procedure	Adrenal Venous Sampling via an Antecubital Approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The success rate of bilateral adrenal sampling		From January 1st 2012 to December 31st 2018

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refusal of the principal investigator to participate to the AVSA Study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiongjing Jiang, MD	Contact	+861088322385		jxj103@hotmail.com
Hui Dong, MD	Contact	+861088322385		donghui666@sina.com

Overall Officials

Name	Affiliation	Role
Xiongjing Jiang, MD	Fuwai Hospital, National Center for Cardiovascular Disease	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Recruiting	Beijing	Beijing Municipality	100037	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37466201	Derived	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.

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases