Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-30 @ 4:26 PM
Study NCT ID:
NCT03962361
Status:
UNKNOWN
Last Update Posted:
2019-05-24
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Biomarkers of Neurological Outcome After a Sudden Cardiac Death
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Organization:
Study Overview
Official Title:
New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 aim of the project is to establish the value of circulating microparticles as a new biomarker for neurological prognosis of patients recovered from sudden cardiac death who remain comatose.
Detailed Description:
This is a pilot study. Analytical, observational, longitudinal, retrospective and prospective, non-randomized. Patients recovered from sudden cardiac death of ischemic cause and remain comatose will be included in the protocol if they fit the pre-specified inclusion criteria. Biological samples will be collected (at admission, at 24 and 72 hours) and stored in the Biobank of Hospital de la Santa Creu i Sant Pau for further analysis. In addition demographic, clinical and analytical variables will be collected. At the end of the recruitment period, we will analyse the concentrations of circulating microparticles according to ICCC-IIBSantPau methodology in the samples obtained. The primary outcome variable will be the neurological status at Coronary Care Unit discharge and at 6 months. The objective of the study will evaluate the relationship between the neurological status and the blood concentrations of circulating microparticles.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: