Adrenal Vein Sampling International Study (AVIS Study)
This study has been completed.
Sponsor:
University Hospital Padova
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
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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:
Genetics Home Reference related topics:
congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency
Cushing disease
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
U.S. FDA Resources
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
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 Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Epinephrine Epinephryl borate Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013