NCT03962361

New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Sudden Death
• Hypoxia Brain
• Cell Membrane Microparticles
• Biomarkers

Interventions

Type	Name	Description
OTHER	Concentration of circulating microparticles.	The microparticles contained in the blood sample will be isolated by ultracentrifugation and quantified by flow cytometry. The microparticles concentration will be determined by the number of microparticles per uL of plasma, based on the volume of the sample, the flow rate of the cytometer and the number of fluorescent events.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2019-05-24
• Last updated: 2019-05-24

Locations

1 site across 1 country: Spain