Clinical trial NCT03778645: Adrenal Venous Sampling Via an Antecubital Approach
Official title: Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperaldosteronism
Angiography
Keywords: Adrenal venous sampling
Hyperaldosteronism
Angiography
Antecubital approach
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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

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.

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

Primary outcomes:
measure: The success rate of bilateral adrenal sampling
timeFrame: From January 1st 2012 to December 31st 2018
Secondary outcomes:
measure: The success rate of right adrenal sampling
timeFrame: From January 1st 2012 to December 31st 2018
measure: The success rate of left adrenal sampling
timeFrame: From January 1st 2012 to December 31st 2018
measure: The incidence of adrenal vein ruptures occurring during AVS
timeFrame: From January 1st 2012 to December 31st 2018
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: Xi'an NO.3 Hospital
state: Shanxi
city: Shihezi
country: China
facility: The First Affiliated Hospital of Medical College of Shihezi Universtiy
state: Xinjiang
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease
name: Xiongjing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: