Cardiac Arrest Recovery EEG Study (CARES)
Recruitment status was: Recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest|
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||December 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483873
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21187|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|United States, Wisconsin|
|Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Neil S Rothman, PhD||Infinite Biomedical Technologies - Study Sponsor|
|Principal Investigator:||Romergryko Geocadin, MD||Johns Hopkins University|
|Principal Investigator:||Michel Torbey, MD, MPH||Medical College of Wisconsin|
|Principal Investigator:||Mary Ann Peberdy, MD||Virginia Commonwealth University|