Cardiac Arrest Recovery EEG Study (CARES)

Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest

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.

Study Overview

• Status: Unknown
• Conditions: Arrhythmia; Cardiac Arrest

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Principal Investigator: Romergryko Geocadin, MD
    • Baltimore, Maryland, United States, 21187
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Daniel F Hanley, MD; Phone Number: 410-614-6996; Email: dhanley@jhmi.edu
      • Principal Investigator: Romergryko Geocadin, MD
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Not yet recruiting
      • Virginia Commonwealth University
      • Contact: Mary Ann Peberdy, MD; Phone Number: 804-828-4571; Email: mpeberdy@aol.com
      • Principal Investigator: Mary Ann Peberdy, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
      • Contact: Michel Torbey, MD,MPH; Phone Number: 414-805-5343; Email: mtorbey@mcw.edu
      • Principal Investigator: Michel Torbey, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital after out-of-hospital Cardiac arrest or for an ICD placement

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Infinite Biomedical Technologies
• Collaborators: Johns Hopkins University; National Heart, Lung, and Blood Institute (NHLBI); Johns Hopkins Bloomberg School of Public Health; Medical College of Wisconsin; Virginia Commonwealth University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: June 6, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (Estimate): June 7, 2007

Study Record Updates

• Last Update Posted (Estimate): January 29, 2009
• Last Update Submitted That Met QC Criteria: January 28, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Cardiac Arrest, Neurological Recovery, EEG, Quantitative EEG
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: R44HL070129 (U.S. NIH Grant/Contract)