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Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death (AWAKE)

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ClinicalTrials.gov Identifier: NCT03248557
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Hospital Universitario La Paz
Hospital General de Ciudad Real
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Hospital General Universitario Gregorio Marañon
Sociedad Española de Cardiología
Fundacion Investigacion Interhospitalaria Cardiovascular
Information provided by (Responsible Party):
David Filgueiras-Rama, Hospital San Carlos, Madrid

Brief 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.

Condition or disease Intervention/treatment
Sudden Cardiac Death Ventricular Fibrillation Reperfusion Injury Diagnostic Test: Spectral analysis of ventricular fibrillation tracings

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Study Type : Observational
Estimated Enrollment : 143 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Early Prognostic Value of an Algorithm Based on Spectral Variables of Ventricular fibrillAtion From the EKG of Patients With suddEn Cardiac Death: a Multicenter Observational Trial
Study Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study
Comatose survivors (GCS ≤8) after RoSC, in whom neurological prognosis is unknown at the time of admission. Neurological performance of patients from the study group (prospective and retrospective) will be categorized according to a risk score obtained from the multivariate spectral-based model.
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.

Control
Patients who are conscious (GCS=15) and whose neurological status is known and good at admission.
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.




Primary Outcome Measures :
  1. Favorable neurological performance (FNP) during hospitalization [ Time Frame: Hospitalization, up to 2 months after admission ]

    Patients will be assessed using the Pittsburgh Cerebral Performance Categories (CPC) outcome categorization of brain injury. They will be considered to have FNP if they score 1 or 2 in the CPC scale (good performance and moderate disability, respectively). CPCs 3, 4 and 5 (severe disability, vegetative state and brain death, respectively) will be considered as a non-FNP.

    In the prospective cohort, FNP will also be determined using the mini-mental state examination (cut-off value 24/30).



Secondary Outcome Measures :
  1. Survival to hospital discharge [ Time Frame: Hospitalization, up to 2 months ]
    Patients discharged alive

  2. Favorable neurological performance (FNP) at follow-up [ Time Frame: 6 months after discharge (prospective patients) or at patient enrollment (retrospective patients) ]
    Patients will be assessed using the Pittsburgh Cerebral Performance Categories (CPC) outcome categorization of brain injury. They will be considered to have FNP if they score 1 or 2 in the CPC scale (good performance and moderate disability, respectively). CPCs 3, 4 and 5 (severe disability, vegetative state and brain death, respectively) will be considered as a non-FNP.

  3. Survival at follow-up [ Time Frame: 6 months after discharge (prospective patients) or at patient enrollment (retrospective patients) ]
    Patients alive at the time of follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients admitted to the hospital after out or in-hospital cardiac arrest due to VF will be registered and screened for potential inclusion in the study. Patients will be classified into either of two groups:

  1. Study group: comatose survivors (GCS ≤8) after RoSC, in whom neurological prognosis is unknown at the time of admission. This group is divided into a prospective cohort (new admissions), and a retrospective one, in which cases will be obtained from existing databases in the participating centers.
  2. Control group: patients who are conscious (GCS=15) and whose neurological status is known and good at admission. This will be the control group for the spectral-based predictive model (gold standard for FNP).
Criteria

Inclusion Criteria:

  • In or out-of-hospital cardiac arrest with ventricular fibrillation (VF) as first documented rhythm.
  • A ≥3-second VF tracings before the first direct current (DC) shock.
  • Signed informed consent. Patients unable to consent, it will be requested to an authorized relative.
  • Study group: GCS ≤8 and subject to temperature management (hypothermia 32-34ºC or normothermia 36ºC).
  • Control group: GCS=15, thus no indication for temperature management.

Exclusion Criteria:

  • First documented rhythm other than VF (e.g. ventricular tachycardia, pulseless electrical activity, asystole)
  • Unavailable or suboptimal quality of the ECG tracing before the first DC shock.
  • Terminal disease or cognitive impairment before the SCD event.
  • Other possible causes of comatose status different from SCD (e.g. drugs, traumatic brain injury, hypoxia).
  • Aged under 18 .
  • Unwilling to provide the informed consent.
  • Comatose status (GCS≤8) and absence of temperature management or GCS ≥9 if temperature management was undertaken.
  • Hemodynamic instability leading to incomplete 24 h of temperature management
  • Early mortality and absence of subsequent withdrawal of sedation to assess cerebral performance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248557


Contacts
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Contact: David Filgueiras-Rama, MD +913303696 david.filgueiras@cnic.es
Contact: Julián Palacios-Rubio, MD +913307045 palaciosrubioj@gmail.com

Locations
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Spain
Hospital General Universitario de Ciudad Real Recruiting
Ciudad Real, Spain, 13005
Contact: Carmen Corcobado-Márquez, MD    +34926278000 ext 78753    mccorcobado@hotmail.com   
Principal Investigator: Carmen Corcobado-Márquez, MD         
Sub-Investigator: Francisco Ruiz-Lorenzo, MD         
Sub-Investigator: Carmen Espinosa-González, MD         
Hospital General Universitario Gregorio Marañón Active, not recruiting
Madrid, Spain, 28007
Fundación Centro Nacional de Investigaciones Cardiovasculares, Carlos III Active, not recruiting
Madrid, Spain, 28029
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: David Filgueiras-Rama, MD    +34913303696    david.filgueiras@cnic.es   
Contact: Julián Palacios-Rubio, MD    +34913307045    julian.palacios@salud.madrid.org   
Principal Investigator: Julián Palacios-Rubio, MD         
Sub-Investigator: Inés García-González, MD         
Sub-Investigator: José M. Gil-Perdomo, MD         
Sub-Investigator: María Bringas-Bollada, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Esteban López de Sa, MD    +34917277000    estebanlopezdesa@secardiologia.es   
Principal Investigator: Esteban López de Sa, MD         
Sub-Investigator: Verónica Rial-Bastón, MD         
Sponsors and Collaborators
Hospital San Carlos, Madrid
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Hospital Universitario La Paz
Hospital General de Ciudad Real
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Hospital General Universitario Gregorio Marañon
Sociedad Española de Cardiología
Fundacion Investigacion Interhospitalaria Cardiovascular
Investigators
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Principal Investigator: David Filgueiras-Rama, MD Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Chair: Manuel Marina-Breysse, MD Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Chair: María-Jesús García-Torrent, PharmD, PhD Hospital Clínico San Carlos
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Filgueiras-Rama, MD, PhD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03248557    
Other Study ID Numbers: 16/405-E
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Filgueiras-Rama, Hospital San Carlos, Madrid:
resuscitation
wavelet analysis
spectral analysis
post-cardiac arrest syndrome
Additional relevant MeSH terms:
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Reperfusion Injury
Death, Sudden, Cardiac
Ventricular Fibrillation
Death
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Heart Arrest
Heart Diseases
Death, Sudden
Arrhythmias, Cardiac