Cardiac Arrest Recovery EEG Study (CARES)
Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21224
- Rekrutierung
- Johns Hopkins Bayview Medical Center
-
Hauptermittler:
- Romergryko Geocadin, MD
-
Baltimore, Maryland, Vereinigte Staaten, 21187
- Rekrutierung
- Johns Hopkins Hospital
-
Kontakt:
- Daniel F Hanley, MD
- Telefonnummer: 410-614-6996
- E-Mail: dhanley@jhmi.edu
-
Hauptermittler:
- Romergryko Geocadin, MD
-
-
Virginia
-
Richmond, Virginia, Vereinigte Staaten, 23298
- Noch keine Rekrutierung
- Virginia Commonwealth University
-
Kontakt:
- Mary Ann Peberdy, MD
- Telefonnummer: 804-828-4571
- E-Mail: mpeberdy@aol.com
-
Hauptermittler:
- Mary Ann Peberdy, MD
-
-
Wisconsin
-
Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Rekrutierung
- Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
-
Kontakt:
- Michel Torbey, MD,MPH
- Telefonnummer: 414-805-5343
- E-Mail: mtorbey@mcw.edu
-
Hauptermittler:
- Michel Torbey, MD, MPH
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Neil S Rothman, PhD, Infinite Biomedical Technologies - Study Sponsor
- Hauptermittler: Romergryko Geocadin, MD, Johns Hopkins University
- Hauptermittler: Michel Torbey, MD, MPH, Medical College of Wisconsin
- Hauptermittler: Mary Ann Peberdy, MD, Virginia Commonwealth University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R44HL070129 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .