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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01234220




Registration number
NCT01234220
Ethics application status
Date submitted
2/11/2010
Date registered
4/11/2010
Date last updated
15/01/2013

Titles & IDs
Public title
Adrenal Vein Sampling International Study (AVIS Study)
Scientific title
Multicenter Study on Use and Interpretation of Adrenal Vein Sampling
Secondary ID [1] 0 0
GPR-AVIS
Universal Trial Number (UTN)
Trial acronym
AVIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperaldosteronism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adrenal Venous Sampling (AVS) - Patients with Primary Aldosteronism (PA) undergoing AVS to discriminate PA forms with unilateral from bilateral excess aldosterone production.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adrenal vein ruptures occurring during AVS
Timepoint [1] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [1] 0 0
AVS cost for the patient and the health insurance system
Timepoint [1] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [2] 0 0
number of selective AVS at right or left side
Timepoint [2] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [3] 0 0
number of bilaterally selective AVS
Timepoint [3] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [4] 0 0
number of lateralized AVS and number of the patients undergoing adrenalectomy
Timepoint [4] 0 0
January 1st 2005 - November 1st 2010

Eligibility
Key inclusion criteria
* consent of the leading investigator to participate to the data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* refusal of the leading investigator to participate to the AVIS Study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
2604
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4120 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Prague
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Düsseldorf
Country [10] 0 0
Germany
State/province [10] 0 0
Munich
Country [11] 0 0
Germany
State/province [11] 0 0
Wuerzburg
Country [12] 0 0
Italy
State/province [12] 0 0
Padua
Country [13] 0 0
Italy
State/province [13] 0 0
Reggio Emilia
Country [14] 0 0
Japan
State/province [14] 0 0
Kyoto
Country [15] 0 0
Japan
State/province [15] 0 0
Sendai
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Japan
State/province [17] 0 0
Yokohama City
Country [18] 0 0
Netherlands
State/province [18] 0 0
Nijmegen
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital Padova
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GianPaolo Rossi, MD, FACC
Address 0 0
Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01234220