Adrenal Vein Sampling International Study (AVIS Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova
ClinicalTrials.gov Identifier:
NCT01234220
First received: November 2, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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
Hyperaldosteronism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Study on Use and Interpretation of Adrenal Vein Sampling

Resource links provided by NLM:


Further study details as provided by University Hospital Padova:

Primary Outcome Measures:
  • Number of adrenal vein ruptures occurring during AVS [ Time Frame: January 1st 2005 - November 1st 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AVS cost for the patient and the health insurance system [ Time Frame: January 1st 2005 - November 1st 2010 ] [ Designated as safety issue: No ]
    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.

  • number of selective AVS at right or left side [ Time Frame: January 1st 2005 - November 1st 2010 ] [ Designated as safety issue: No ]
    The number of selective AVS at right or left side will be calculated using different cutoff values for the selectivity index.

  • number of bilaterally selective AVS [ Time Frame: January 1st 2005 - November 1st 2010 ] [ Designated as safety issue: No ]
    The number of bilaterally selective AVS will be calculated using different cutoff values for the selectivity index.

  • number of lateralized AVS and number of the patients undergoing adrenalectomy [ Time Frame: January 1st 2005 - November 1st 2010 ] [ Designated as safety issue: No ]
    The number of lateralized AVS will be calculated using different cutoff values for the lateralization index.


Enrollment: 2604
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adrenal Venous Sampling (AVS)
Patients with Primary Aldosteronism (PA) undergoing AVS to discriminate PA forms with unilateral from bilateral excess aldosterone production.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234220

Locations
United States, Pennsylvania
Hospital of The University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
Medical College of Wisconsin
Menomonee Falls, Wisconsin, United States, 53051
Australia
Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital
Brisbane, Australia, 4120
Canada, Alberta
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada
Canada, Quebec
Centre Hospitalier de l'Université de Montreal (CHUM)
Montreal, Quebec, Canada
Czech Republic
General Faculty Hospital, Prague
Prague, Czech Republic
France
University of Paris, Hopital Européen Georges Pompidou
Paris, France
Germany
Christian J Strasburger
Berlin, Germany, 10117
Heinrich Heine Universität Düsseldorf
Düsseldorf, Germany
Medizinische Klinik Innenstadt
Munich, Germany
University Hospital Wuerzburg
Wuerzburg, Germany, 97080
Italy
Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy
Padua, Italy
Medicina 2, Dipartimento di Medicina Interna e Specialità Mediche, Azienda Ospedaliera Santa Maria Nuova
Reggio Emilia, Italy, 42123
Japan
National Hospital Organizatio, Kyoto Medical Center
Kyoto, Japan
Tohoku University Hospital
Sendai, Japan
Institute of Clinical Endocrinology, Tokyo Women's Medical University
Tokyo, Japan
Yokohama Rosai Hospital
Yokohama City, Japan
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6525GA
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
University Hospital Padova
Investigators
Study Director: GianPaolo Rossi, MD, FACC Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gian Paolo Rossi, MD, FAHA, FACC, MD, FAHA, FACC, University Hospital Padova
ClinicalTrials.gov Identifier: NCT01234220     History of Changes
Other Study ID Numbers: GPR-AVIS
Study First Received: November 2, 2010
Last Updated: January 14, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Hospital Padova:
Aldosterone
Primary Aldosteronism
Aldosterone Producing Adenoma (APA)
Idiopathic Adrenal Hyperplasia (IHA)
Adrenal Venous Sampling

Additional relevant MeSH terms:
Hyperaldosteronism
Adrenal Gland Diseases
Adrenocortical Hyperfunction
Endocrine System Diseases
Epinephrine
Epinephryl borate
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 23, 2014