Cardiac Arrest Recovery EEG Study

NCT ID: NCT00483873

Last Updated: 2009-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-12-31

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.

Conditions

Cardiac Arrest; Arrhythmia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Infinite Biomedical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

IInfinite Biomedical Technologies, llc

Principal Investigators

Neil S Rothman, PhD

Role: PRINCIPAL_INVESTIGATOR

Infinite Biomedical Technologies - Study Sponsor

Romergryko Geocadin, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Michel Torbey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Mary Ann Peberdy, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: NOT_YET_RECRUITING

Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Romergryko Geocadin, MD

Role: CONTACT

rgeocadi@jhmi.edu

410-614-6145

Facility Contacts

Daniel F Hanley, MD

Role: primary

dhanley@jhmi.edu

410-614-6996

Mary Ann Peberdy, MD

Role: primary

mpeberdy@aol.com

804-828-4571

Michel Torbey, MD,MPH

Role: primary

mtorbey@mcw.edu

414-805-5343

Other Identifiers

R44HL070129

Identifier Type: NIH

Identifier Source: secondary_id

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R44HL070129

Identifier Type: NIH

Identifier Source: org_study_id

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