Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death

Summary

Ventricular fibrillation (VF)-related sudden cardiac death (SCD) is a leading cause of mortality. Patients may survive with neurological damage despite state-of-the-art treatment. Current biological and imaging parameters show significant limitations on early predicting cerebral performance at hospital admission. A spectral-based model was recently suggested to correlate time-dependent VF spectral changes with acute cerebral injury in comatose survivors after cardiac arrest, which opens the possibility to implement early prognostic tools in clinical practice. The AWAKE trial is an investigator-initiated, multicenter, observational trial aiming to validate a spectral-based model to early predict cerebral performance and survival in resuscitated comatose survivors admitted to specialized intensive care units. The primary clinical outcome is favorable neurological performance (FNP) during hospitalization. Patients will be categorized into 4 subsets of NP according to the risk score obtained from the predictive model. The secondary clinical outcomes are survival to hospital discharge, and FNP and survival after 6 months of follow-up. Model-derived categorization will be compared with clinical outcomes to assess model sensitivity, specificity and accuracy. Eligible patients will be included prospectively and retrospectively, using an electronic Case Report Form to enter data from medical records and in-person interviews. Patients will be divided into: study group (predictive data required) including comatose (Glasgow Coma Scale -GCS- ≤8) survivors undergoing temperature control after return of spontaneous circulation (RoSC), and control group including patients who regain consciousness (GCS=15) after RoSC. VF tracings prior to the first DC shock will be digitized and analyzed to derive spectral data and risk scores.

Conditions

• Sudden Cardiac Death
• Ventricular Fibrillation
• Reperfusion Injury

Interventions

DIAGNOSTIC_TEST

Spectral analysis of ventricular fibrillation tracings

Up to 5-s long ventricular fibrillation segments will be extracted after segmentation and signal codification from artifact-free tracings. Signals will be band-pass filtered between 1.5 and 40 Hz. Averaged power spectral density will be obtained at each frequency using the non-parametric Welch method for using fast Fourier transform and normalized to the peak power in the 1.5-10 Hz band for each patient. Dominant frequency, HL-PSDR (the relative power between high and low frequency bands (cut-off: 3.9 Hz)) and HL-pKR ( relative number of spectral peaks above and below the 3.9 Hz threshold with power above 40% the frequency with the highest power), along with the number of DC shocks before ROSC, will be the variables used to obtain a model-derived risk score for outcome prediction.

Sponsors & Collaborators

• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital General de Ciudad Real

  collaborator OTHER

• Fundación de Investigación en Red en Enfermedades Cardiovasculares

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Spanish Society of Cardiology

  collaborator OTHER

• Fundacion Investigacion Interhospitalaria Cardiovascular

  collaborator OTHER

• Hospital San Carlos, Madrid

  lead OTHER

Principal Investigators

• David Filgueiras-Rama, MD · Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

• Manuel Marina-Breysse, MD · Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

• María-Jesús García-Torrent, PharmD, PhD · Hospital San Carlos, Madrid

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2022-09-30

Completion

2023-03-31

Countries

• Spain

Study Locations