View Clinical Trial (Medical Research Study)
Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
| City: |
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Richmond |
| State: |
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Virginia |
| Zip Code: |
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23298 |
| Conditions: |
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Cardiac Arrest - Arrhythmia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00483873 |
| Primary Contact: |
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Principal Investigator
Neil S Rothman, PhD
Infinite Biomedical Technologies - Study Sponsor
Romergryko Geocadin, MD
Phone: 410-614-6145
Email: rgeocadi@jhmi.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Richmond, Virginia 23298
United States
Mary Ann Peberdy, MD
Phone: 804-828-4571
Email: mpeberdy@aol.com
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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