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Adrenal Vein Sampling International Study (AVIS Study)

NCT01234220 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2604

Last updated 2013-01-15

No results posted yet for this study

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.

Conditions

  • Hyperaldosteronism

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Principal Investigators

  • GianPaolo Rossi, MD, FACC · Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-06-30
Completion
2011-11-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234220 on ClinicalTrials.gov