Cardiac Arrest Recovery EEG Study (CARES)
Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
Přehled studie
Postavení
Podmínky
Detailní popis
Cardiac arrest claims over 450,000 lives per year in the United States alone. There is a high incidence of neurological complications amongst survivors, and these represent the leading cause of morbidity.
Over the past several years, the care of these patients has been improved via the introduction of new systemic as well as neurospecific therapies. Speed of institution of therapy appears to be an important factor affecting efficacy. Yet, in the crucial initial hours to days post-arrest, assessment of neurological status in these patients is essentially non-existent.
Thus, there is a need for an objective validated tool to assess prognosis and to track neurological status in the early recovery period. In response to this need, we have developed an EEG based Cortical Health Index (CHI). This EEG-based index incorporates multiple weighted parameters derived from 2 channels (4 scalp electrodes + 1 ground electrode) which are related to neurologic functional recovery. The strength and uniqueness of this approach results from consideration of both the temporal as well as the spectral domains of EEG. Our Phase II results demonstrate that CHI measured within the first 6-hours post-arrest resuscitation is strongly correlated with clinical outcome at hospital discharge in a 30-patient cardiac arrest study. Together with our industry collaborator, we now propose to pursue regulatory approval of the CHI Monitor. Our plan involves a prospective clinical trial involving 4 centers and 100 patients (64 Cardiac Arrest Patients and 36 patients undergoing ICD placement as controls). We will test the ability of CHI to: 1) provide early prediction of subsequent neurological functional outcome of cardiac arrest patients, and 2) provide real-time tracking of brain injury and response to therapy. Successful completion of this project is defined by FDA clearance of the CHI Monitor.
It is our goal that the CHI Monitor will identify patients who could benefit from aggressive intervention, and then track the response to the therapy. Providing this information to the treating physician in the immediate post-resuscitation period represents a major change in care delivery for the cardiac arrest survivor.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21224
- Nábor
- Johns Hopkins Bayview Medical Center
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Vrchní vyšetřovatel:
- Romergryko Geocadin, MD
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Baltimore, Maryland, Spojené státy, 21187
- Nábor
- Johns Hopkins Hospital
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Kontakt:
- Daniel F Hanley, MD
- Telefonní číslo: 410-614-6996
- E-mail: dhanley@jhmi.edu
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Vrchní vyšetřovatel:
- Romergryko Geocadin, MD
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Virginia
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Richmond, Virginia, Spojené státy, 23298
- Zatím nenabíráme
- Virginia Commonwealth University
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Kontakt:
- Mary Ann Peberdy, MD
- Telefonní číslo: 804-828-4571
- E-mail: mpeberdy@aol.com
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Vrchní vyšetřovatel:
- Mary Ann Peberdy, MD
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
- Nábor
- Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
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Kontakt:
- Michel Torbey, MD,MPH
- Telefonní číslo: 414-805-5343
- E-mail: mtorbey@mcw.edu
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Vrchní vyšetřovatel:
- Michel Torbey, MD, MPH
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Cardiac Arrest:
Patients 18 years and older:
- with cardiac arrest in the hospital and successfully resuscitated, or
- with cardiac arrest out of the hospital and successfully resuscitated
ICD patients:
Patients 18 years and older:
- Who are undergoing elective procedure in the electrophysiology laboratory for placement of a cardiac defibrillator and who will most likely undergo induction of ventricular arrhythmia as part of the procedure
Exclusion Criteria:
Cardiac Arrest:
- Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
- CNS infection
- Skull defects and scalp diseases that are not amenable to standard EEG testing
ICD patients:
- Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
- CNS infection
- Skull defects and scalp diseases that are not amenable to standard EEG testing
Studijní plán
Jak je studie koncipována?
Detaily designu
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Neil S Rothman, PhD, Infinite Biomedical Technologies - Study Sponsor
- Vrchní vyšetřovatel: Romergryko Geocadin, MD, Johns Hopkins University
- Vrchní vyšetřovatel: Michel Torbey, MD, MPH, Medical College of Wisconsin
- Vrchní vyšetřovatel: Mary Ann Peberdy, MD, Virginia Commonwealth University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R44HL070129 (Grant/smlouva NIH USA)
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