Clinical trial NCT00483873: Cardiac Arrest Recovery EEG Study
Official title: Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Arrhythmia
Keywords: Cardiac Arrest, Neurological Recovery, EEG, Quantitative EEG
Lead sponsor: Infinite Biomedical Technologies
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Johns Hopkins Bloomberg School of Public Health
name: Johns Hopkins University
name: Medical College of Wisconsin
name: Virginia Commonwealth University
First posted: 2007-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital after out-of-hospital Cardiac arrest or for an ICD placement

Brief summary: The purpose of the study is to collect EEG's as close to the cardiac arrest as possible using a standard hospital EEG machine and an investigational EEG device to help determine the neurological status of the cardiac arrest patient and to help decide on possible treatment and chance of recovery. The investigational EEG machine will be simple to operate as well as easy to interpret for the clinician and the nurses. It is not to replace the electrophysiologist interpretation but to determine ealy on if further evaluation and treatment can help the patient.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Cardiac Arrest:

* Patients 18 years and older:

  1. with cardiac arrest in the hospital and successfully resuscitated, or
  2. with cardiac arrest out of the hospital and successfully resuscitated

ICD patients:

* Patients 18 years and older:

  1. 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:

1. Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
2. CNS infection
3. Skull defects and scalp diseases that are not amenable to standard EEG testing

ICD patients:

1. Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
2. CNS infection
3. Skull defects and scalp diseases that are not amenable to standard EEG testing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
state: Wisconsin
Study officials:
affiliation: Infinite Biomedical Technologies - Study Sponsor
name: Neil S Rothman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Romergryko Geocadin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Michel Torbey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Mary Ann Peberdy, MD
role: PRINCIPAL_INVESTIGATOR
References: