New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cerebral Microembolism in Cardiology

NCT03802760

Cerebral Embolism

COMPLETED

Human Cardiac Mitochondria in Acute Endocarditis and Obesity

NCT03690076

Obesity Endocarditis

UNKNOWN

Left Ventricular Structural Predictors of Sudden Cardiac Death

NCT01076660

Ischemic Cardiomyopathy Nonischemic Cardiomyopathy

RECRUITING

Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy

NCT02657967

Non-ischemic Cardiomyopathy

COMPLETED

Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

NCT00181233

Sudden Cardiac Death

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Sudden Death Hypoxia Brain Cell Membrane Microparticles Biomarkers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sudden cardiac death of ischemic cause

Patients admitted to the Coronary Care Unit for sudden cardiac death of ischemic cause and remain comatose (GCS \< 8 points).

Concentration of circulating microparticles.

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 18 years old.
* Patients recovered from a sudden cardiac death (in-hospital and out-of-hospital) with return of spontaneous circulation (ROSC) (defined as systolic blood pressure \> 60 mmHg or palpable pulse for \> 5 minutes) who remain unconsciousness (defined as a score on the Glasgow Coma Scale \<8 ) for \> 5-10 minutes after ROSC.
* Treated with hypothermia as recommended by the European guidelines for resuscitation ( 2010)..

Exclusion Criteria

* Non-cardiac sudden death.
* Active oncologic pathology .
* Traumatic or spontaneous intra-cranial haemorrhage.
* Inability to obtain required blood samples or refusal of the informed consent necessary for it.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No