Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT05007158
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2021-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Procalcitonin as a Biomarker Diagnosing CDI
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Study Overview
Official Title:
A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection
Status:
COMPLETED
Status Verified Date:
2021-07
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:
(DIRT II)
Brief Summary:
Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.
The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection
The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: