Ignite Creation Date:
2025-12-18 @ 8:12 AM
Ignite Modification Date:
2025-12-23 @ 6:50 PM
Study NCT ID:
NCT05781724
Status:
None
Last Update Posted:
2024-09-26 00:00:00
First Post:
2023-02-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Biomarkers and Analytical Methods
Sponsor:
None
Organization:
Study Overview
Official Title:
Cardiac Biomarkers:Comparison Between Analytical Methods
Status:
None
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to evaluate the analytical performance of different kits and molecular markers commercially available (or in pre-industrial development phase) for the assays of the cardiac biomarkers: cTnI , NT-proBNP and sST2.
500 samples (residual serum) from patients hospitalized and/or referred to the DEA Department, for which troponin and/or NT-proBNP tests have been requested routinely or urgently by clinicians, will be included in the study.
The analytical performance of the various kits and the intra- and interassay imprecision will be evaluated. Comparison of methods will be calculated by Passing-Bablok regression and graph by Bland-Altman.
Through the non-parametric Passing-Bablok model the obtained data will be compared with the various analytical methods, reporting them one in function of the other, together with the regression line.
From the regression equation, the proportional systematic error will be evaluated as angular coefficient of the straight line and the constant systematic error as an intercept of the equation
500 samples (residual serum) from patients hospitalized and/or referred to the DEA Department, for which troponin and/or NT-proBNP tests have been requested routinely or urgently by clinicians, will be included in the study.
The analytical performance of the various kits and the intra- and interassay imprecision will be evaluated. Comparison of methods will be calculated by Passing-Bablok regression and graph by Bland-Altman.
Through the non-parametric Passing-Bablok model the obtained data will be compared with the various analytical methods, reporting them one in function of the other, together with the regression line.
From the regression equation, the proportional systematic error will be evaluated as angular coefficient of the straight line and the constant systematic error as an intercept of the equation
Detailed Description:
None
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?: