Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571084
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
New Screening and Diagnostic Cut-off Points of PA Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Establishment and Clinical Application Evaluation of Screening and Diagnostic Cut-off Points With Aldosterone and Renin for Primary Aldosteronism Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule sandwich method aldosterone and renin chemiluminescent immunoassay
Detailed Description:
Primary aldosteronism PA is the most common causes of secondary hypertension The diagnostic workup for PA is composed of multiple steps and requires measurement of both plasma aldosterone and renin In terms of assay of aldosterone most of currently available chemiluminescence assays are based on competitive methods What is actually detected is the sum of aldosterone and its metabolite aldosterone 3C glucuronide which causes the value to be about 50100 higher than the actual value This study aims to establish a new ARR aldosteronerenin ratio cutoff point for PA screening and a new cutoff point for PA diagnosis using a recently developed two-site sandwich chemiluminescence method Snibe China for aldosterone and renin assay
Hypertensive patients referred to hospitals for screening of PA will be included All the participants proceed to seated saline infusion test SIT and captopril challenge test CCT for confirmation Aldosterone and renin will be measured using chemiluminescent immunoassay on the Liaison analyzer DiaSorin Italy and MAGLUMI X8 Snibe China as well as liquid chromatography-tandem mass spectrometry LC-MSMS platform According to the experience of Fuwai Hospital the following diagnosis criteria are proposed Based on the results of currently used DiaSorin Italy aldosterone 85ngdL and renin 15μIUmL after sitting saline infusion conform PA and aldosterone 85ngdL excludes PA
The total number of cases to be enrolled in this study is planned to be 770 including at least 77 positive subjects and at least 406 negative subjects By drawing the ROC curve the point corresponding to the maximum value of the Youden index will be selected as the cutoff value and the corresponding sensitivity specificity positive predictive value negative predictive value positive likelihood ratio negative likelihood ratio etc will be calculated
Hypertensive patients referred to hospitals for screening of PA will be included All the participants proceed to seated saline infusion test SIT and captopril challenge test CCT for confirmation Aldosterone and renin will be measured using chemiluminescent immunoassay on the Liaison analyzer DiaSorin Italy and MAGLUMI X8 Snibe China as well as liquid chromatography-tandem mass spectrometry LC-MSMS platform According to the experience of Fuwai Hospital the following diagnosis criteria are proposed Based on the results of currently used DiaSorin Italy aldosterone 85ngdL and renin 15μIUmL after sitting saline infusion conform PA and aldosterone 85ngdL excludes PA
The total number of cases to be enrolled in this study is planned to be 770 including at least 77 positive subjects and at least 406 negative subjects By drawing the ROC curve the point corresponding to the maximum value of the Youden index will be selected as the cutoff value and the corresponding sensitivity specificity positive predictive value negative predictive value positive likelihood ratio negative likelihood ratio etc will be calculated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None