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Adrenal Venous Sampling Via an Antecubital Approach (AVSA)

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ClinicalTrials.gov Identifier: NCT03778645
Recruitment Status : Unknown
Verified December 2018 by Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Recruiting
First Posted : December 19, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment
Hyperaldosteronism Angiography Procedure: Adrenal Venous Sampling

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018



Intervention Details:
  • Procedure: Adrenal Venous Sampling
    Adrenal Venous Sampling via an Antecubital Approach


Primary Outcome Measures :
  1. The success rate of bilateral adrenal sampling [ Time Frame: From January 1st 2012 to December 31st 2018 ]

Secondary Outcome Measures :
  1. The success rate of right adrenal sampling [ Time Frame: From January 1st 2012 to December 31st 2018 ]
  2. The success rate of left adrenal sampling [ Time Frame: From January 1st 2012 to December 31st 2018 ]
  3. The incidence of adrenal vein ruptures occurring during AVS [ Time Frame: From January 1st 2012 to December 31st 2018 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778645


Contacts
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Contact: Xiongjing Jiang, MD +861088322385 jxj103@hotmail.com
Contact: Hui Dong, MD +861088322385 donghui666@sina.com

Locations
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China, Beijing
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100037
Contact: Xiongjing Jiang, MD    86-1088322385    jxj103@hotmail.com   
Sub-Investigator: Hui Dong, MD         
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China
Contact: Qifu Li, MD    +86-023-89011552      
China, Guangdong
The Eighth Affiliated Hospital of Sun Yat-sen University Recruiting
Shenzhen, Guangdong, China
Contact: Nan Jia, MD    86-0755-83982222    jiananchina@hotmail.com   
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China
Contact: Jianling Li, MD    +8607715359553      
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China
Contact: Min Liu, MD    +96-037165586642      
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China
Contact: Yifei Dong, MD    86-0791-86297662      
China, Liaoning
The Second Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China
Contact: Ying Zhang, MD         
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Jianzhong Xu, MD    86-021-64370045    jianzhongxv@gmail.com   
China, Shanxi
Xi'an NO.3 Hospital Recruiting
Xi'an, Shanxi, China
Contact: Kang Cheng, MD    86-029-61895566    chengkang2009@foxmail.com   
China, Xinjiang
The First Affiliated Hospital of Medical College of Shihezi Universtiy Recruiting
Shihezi, Xinjiang, China
Contact: Zhitao Yan, MD    +86-0993-2859034      
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Xiongjing Jiang, MD Fuwai Hospital, National Center for Cardiovascular Disease
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Responsible Party: Xiongjing Jiang, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03778645    
Other Study ID Numbers: 2018-995
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital:
Adrenal venous sampling
Hyperaldosteronism
Angiography
Antecubital approach
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents