Cardiac Arrest Recovery EEG Study (CARES)
Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
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Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Romergryko Geocadin, MD
- Número de telefone: 410-614-6145
- E-mail: rgeocadi@jhmi.edu
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Recrutamento
- Johns Hopkins Bayview Medical Center
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Investigador principal:
- Romergryko Geocadin, MD
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Baltimore, Maryland, Estados Unidos, 21187
- Recrutamento
- Johns Hopkins Hospital
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Contato:
- Daniel F Hanley, MD
- Número de telefone: 410-614-6996
- E-mail: dhanley@jhmi.edu
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Investigador principal:
- Romergryko Geocadin, MD
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Ainda não está recrutando
- Virginia Commonwealth University
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Contato:
- Mary Ann Peberdy, MD
- Número de telefone: 804-828-4571
- E-mail: mpeberdy@aol.com
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Investigador principal:
- Mary Ann Peberdy, MD
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Recrutamento
- Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
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Contato:
- Michel Torbey, MD,MPH
- Número de telefone: 414-805-5343
- E-mail: mtorbey@mcw.edu
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Investigador principal:
- Michel Torbey, MD, MPH
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
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Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Neil S Rothman, PhD, Infinite Biomedical Technologies - Study Sponsor
- Investigador principal: Romergryko Geocadin, MD, Johns Hopkins University
- Investigador principal: Michel Torbey, MD, MPH, Medical College of Wisconsin
- Investigador principal: Mary Ann Peberdy, MD, Virginia Commonwealth University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
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Outros números de identificação do estudo
- R44HL070129 (Concessão/Contrato do NIH dos EUA)
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