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Adrenal Vein Sampling International Study (AVIS Study) (AVIS)

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ClinicalTrials.gov Identifier: NCT01234220
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova

Brief Summary:

The AVIS Study is a retrospective multicenter international study that aims to answer a series of questions on the use and performance of adrenal venous catheterization (AVS) for the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated among the centres that are internationally recognized and have published in the field of AVS and have agreed to participate in the study.

The first aim of the AVIS study is to collect summary data on how AVS is being performed throughout the world to answer the following questions:

  • How many AVS studies haw been performed yearly from 2005 to 2010 at each center?
  • How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of adrenal vein rupture been steady or has it changed over the 5 years?
  • How many centers use bilaterally simultaneous and how many use sequential AVS catheterization?
  • How many radiologists perform AVS at each center?
  • How many centers use a cosyntropin stimulation during AVS?
  • What is the percentage of PA patients in whom AVS is performed?
  • How many centres calculate the selectivity index? What is the minimum cutoff used?
  • How many centers calculate the lateralization index? What is the minimum cutoff used?
  • Are the AVS studies that are not bilaterally selective used for diagnosis?
  • How many centers calculate the controlateral suppression index and what is the minimum cutoff used?
  • What is the cost of AVS for the National Health System or Insurance and for patients? The second aim of the study is to calculate the rate of AVS studies that are selective and show lateralization of aldosterone excess at each center by applying predefined set of criteria for defining selectivity and lateralization. Data on the final diagnosis of the PA subtype will be gathered and used as reference to assess the performance of AVS using receiver operating characteristic curves analysis and the Youden index to determine the optimal cutoffs. A worksheet will need to be completed providing information on the following: Demography; Date of AVS;Baseline blood pressure (BP) values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol concentration in the infra-adrenal inferior vena cava and in the right and left adrenal vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy); post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or RM) and AVS.

Condition or disease
Hyperaldosteronism

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Study Type : Observational
Actual Enrollment : 2604 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Study on Use and Interpretation of Adrenal Vein Sampling
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : November 2011


Group/Cohort
Adrenal Venous Sampling (AVS)
Patients with Primary Aldosteronism (PA) undergoing AVS to discriminate PA forms with unilateral from bilateral excess aldosterone production.



Primary Outcome Measures :
  1. Number of adrenal vein ruptures occurring during AVS [ Time Frame: January 1st 2005 - November 1st 2010 ]

Secondary Outcome Measures :
  1. AVS cost for the patient and the health insurance system [ Time Frame: January 1st 2005 - November 1st 2010 ]
    The amount in euros that the patient and the health insurance system has to pay for the AVS study will be estimated in each center.

  2. number of selective AVS at right or left side [ Time Frame: January 1st 2005 - November 1st 2010 ]
    The number of selective AVS at right or left side will be calculated using different cutoff values for the selectivity index.

  3. number of bilaterally selective AVS [ Time Frame: January 1st 2005 - November 1st 2010 ]
    The number of bilaterally selective AVS will be calculated using different cutoff values for the selectivity index.

  4. number of lateralized AVS and number of the patients undergoing adrenalectomy [ Time Frame: January 1st 2005 - November 1st 2010 ]
    The number of lateralized AVS will be calculated using different cutoff values for the lateralization index.



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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 who underwent AVS during the last 5 years in 15 worldwide centers.
Criteria

Inclusion Criteria:

  • consent of the leading investigator to participate to the data collection

Exclusion Criteria:

  • refusal of the leading investigator to participate to the AVIS 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): NCT01234220


Locations
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Sponsors and Collaborators
University Hospital Padova
Investigators
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Study Director: GianPaolo Rossi, MD, FACC Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gian Paolo Rossi, MD, FAHA, FACC, MD, FAHA, FACC, University Hospital Padova
ClinicalTrials.gov Identifier: NCT01234220    
Other Study ID Numbers: GPR-AVIS
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013
Keywords provided by Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova:
Aldosterone
Primary Aldosteronism
Aldosterone Producing Adenoma (APA)
Idiopathic Adrenal Hyperplasia (IHA)
Adrenal Venous Sampling
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases