NCT00483873

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

First QC Date

June 6, 2007

Last Update Submit

January 28, 2009

Conditions

Keywords

Cardiac Arrest, Neurological Recovery, EEG, Quantitative EEG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins Hospital

Baltimore, Maryland, 21187, United States

RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

NOT YET RECRUITING

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

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Heart ArrestArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romergryko Geocadin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

August 1, 2007

Study Completion

December 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations