副腎静脈サンプリング国際研究（AVIS研究）

基本情報

NCT ID

NCT01234220

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

2,604

治験依頼者名

University Hospital Padova

概要

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.

対象疾患

依頼者（Sponsor）

実施施設 (4)