Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death (NCT03248557) | Clinical Trial Compass
CompletedNot Applicable
Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death
Spain168 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study analyzed the electrical patterns of ventricular fibrillation to try to predict who survives cardiac arrest with good brain function — does the type of ventricular fibrillation I experienced, or my loved one experienced, give any clues about expected neurological recovery based on what studies like this have found?
2Since this trial is completed and was measuring 'favorable neurological performance' during hospitalization, has any published data from it changed how your team interprets cardiac arrest cases or guides decisions about ongoing care?
3The study also looked at reperfusion injury, which is damage that can happen when blood flow returns to the heart after a cardiac arrest — is that a concern in this situation, and are there treatments your team uses to reduce that risk?
4This was a prognostic study, meaning it was trying to predict outcomes rather than test a new treatment — does that mean the findings might help you give us a clearer picture of what neurological recovery might look like, and how do you use tools like this in your own assessments?
5Since this trial is already completed and not enrolling anyone, are there other active studies or newer approaches to improving outcomes after ventricular fibrillation that might be worth discussing as options right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Favorable neurological performance (FNP) during hospitalization
Timeframe: Hospitalization, up to 2 months after admission