Cardiac Arrest Recovery EEG Study (CARES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Infinite Biomedical Technologies.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins University
Medical College of Wisconsin
Virginia Commonwealth University
Information provided by:
Infinite Biomedical Technologies
ClinicalTrials.gov Identifier:
NCT00483873
First received: June 6, 2007
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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.


Condition
Cardiac Arrest
Arrhythmia

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Infinite Biomedical Technologies:

Estimated Enrollment: 100
Study Start Date: August 2007
Estimated Study Completion Date: December 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483873

Contacts
Contact: Romergryko Geocadin, MD 410-614-6145 rgeocadi@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21187
Contact: Daniel F Hanley, MD    410-614-6996    dhanley@jhmi.edu   
Principal Investigator: Romergryko Geocadin, MD         
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Romergryko Geocadin, MD         
United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Mary Ann Peberdy, MD    804-828-4571    mpeberdy@aol.com   
Principal Investigator: Mary Ann Peberdy, MD         
United States, Wisconsin
Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michel Torbey, MD,MPH    414-805-5343    mtorbey@mcw.edu   
Principal Investigator: Michel Torbey, MD, MPH         
Sponsors and Collaborators
Infinite Biomedical Technologies
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins University
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
  More Information

No publications provided

Responsible Party: Dr. Neil Rothman, Vice-President of Research and Development, IInfinite Biomedical Technologies, llc
ClinicalTrials.gov Identifier: NCT00483873     History of Changes
Other Study ID Numbers: R44HL070129, R44HL070129
Study First Received: June 6, 2007
Last Updated: January 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Infinite Biomedical Technologies:
Cardiac Arrest, Neurological Recovery, EEG, Quantitative EEG

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014