<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03778645</url>
  </required_header>
  <id_info>
    <org_study_id>2018-995</org_study_id>
    <nct_id>NCT03778645</nct_id>
  </id_info>
  <brief_title>Adrenal Venous Sampling Via an Antecubital Approach</brief_title>
  <acronym>AVSA</acronym>
  <official_title>Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA.&#xD;
      Right adrenal vein catheterization is often difficult due to unfavorable anatomy of the vein&#xD;
      including small vein size, short length, caudal direction for the transfemoral approach, and&#xD;
      rare drainage to the accessory hepatic vein. All of these factors limit the widespread use of&#xD;
      this approach. Given that the right adrenal vein is angled caudally in most patients, AVS via&#xD;
      an antecubital approach was performed since January 2012. The purpose of this multicenter&#xD;
      retrospective study was to evaluate the safety and feasibility of AVS via the antecubital&#xD;
      approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary aldosteronism (PA) is recognized as the most common cause of secondary hypertension,&#xD;
      with a prevalence of approximately 10% among unselected hypertensive populations. Subtype&#xD;
      diagnosis is crucial because unilateral primary aldosteronism can be treated by laparoscopic&#xD;
      adrenalectomy or open surgery, which may result in a cure or significant improvement of blood&#xD;
      pressure, thus decreases the incidence of cardio-cerebrovascular complications. Currently,&#xD;
      adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Given that the&#xD;
      right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was&#xD;
      performed since January 2012 at the Fuwai Hospital. So far, there have been more than fifteen&#xD;
      hospitals to have some experience on AVS via antecubital approach with investigators' helps.&#xD;
      The purpose of this multicenter retrospective study was to evaluate the safety and&#xD;
      feasibility of AVS via the antecubital approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The success rate of bilateral adrenal sampling</measure>
    <time_frame>From January 1st 2012 to December 31st 2018</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The success rate of right adrenal sampling</measure>
    <time_frame>From January 1st 2012 to December 31st 2018</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The success rate of left adrenal sampling</measure>
    <time_frame>From January 1st 2012 to December 31st 2018</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of adrenal vein ruptures occurring during AVS</measure>
    <time_frame>From January 1st 2012 to December 31st 2018</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Hyperaldosteronism</condition>
  <condition>Angiography</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adrenal Venous Sampling</intervention_name>
    <description>Adrenal Venous Sampling via an Antecubital Approach</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with primary aldosteronism underwent AVS via antecubital approach between&#xD;
        January 1st 2012 and December 31st 2018 in medical centers (agreement of the principal&#xD;
        investigator to participate to the AVSA) in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consent of the principal investigator to participate to the data collection of&#xD;
             patients with primary aldosteronism underwent AVS via antecubital approach&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the principal investigator to participate to the AVSA Study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiongjing Jiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital, National Center for Cardiovascular Disease</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiongjing Jiang, MD</last_name>
    <phone>+861088322385</phone>
    <email>jxj103@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hui Dong, MD</last_name>
    <phone>+861088322385</phone>
    <email>donghui666@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiongjing Jiang, MD</last_name>
      <phone>86-1088322385</phone>
      <email>jxj103@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Hui Dong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qifu Li, MD</last_name>
      <phone>+86-023-89011552</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Eighth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nan Jia, MD</last_name>
      <phone>86-0755-83982222</phone>
      <email>jiananchina@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianling Li, MD</last_name>
      <phone>+8607715359553</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Liu, MD</last_name>
      <phone>+96-037165586642</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yifei Dong, MD</last_name>
      <phone>86-0791-86297662</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Zhang, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianzhong Xu, MD</last_name>
      <phone>86-021-64370045</phone>
      <email>jianzhongxv@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xi'an NO.3 Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kang Cheng, MD</last_name>
      <phone>86-029-61895566</phone>
      <email>chengkang2009@foxmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Medical College of Shihezi Universtiy</name>
      <address>
        <city>Shihezi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhitao Yan, MD</last_name>
      <phone>+86-0993-2859034</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Xiongjing Jiang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Adrenal venous sampling</keyword>
  <keyword>Hyperaldosteronism</keyword>
  <keyword>Angiography</keyword>
  <keyword>Antecubital approach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperaldosteronism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03778645
org study id: 2018-995
nct id: NCT03778645
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: The success rate of bilateral adrenal sampling
time frame: From January 1st 2012 to December 31st 2018
measure: The success rate of right adrenal sampling
time frame: From January 1st 2012 to December 31st 2018
measure: The success rate of left adrenal sampling
time frame: From January 1st 2012 to December 31st 2018
measure: The incidence of adrenal vein ruptures occurring during AVS
time frame: From January 1st 2012 to December 31st 2018
intervention type: Procedure
intervention name: Adrenal Venous Sampling
description: Adrenal Venous Sampling via an Antecubital Approach
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiongjing Jiang, MD
role: Principal Investigator
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease
last name: Xiongjing Jiang, MD
phone: +861088322385
email: jxj103@hotmail.com
last name: Hui Dong, MD
phone: +861088322385
email: donghui666@sina.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Xiongjing Jiang
investigator title: Professor
mesh term: Hyperaldosteronism
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Epinephryl borate
sharing ipd: No