Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483873
Status:
UNKNOWN
Last Update Posted:
2009-01-29
First Post:
2007-06-06
Brief Title:
Cardiac Arrest Recovery EEG Study
Sponsor:
Infinite Biomedical Technologies
Organization:
Infinite Biomedical Technologies
Study Overview
Official Title:
Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARES
Brief Summary:
The purpose of the study is to collect EEGs 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 450000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44HL070129 | NIH | None | httpsreporternihgovquickSearchR44HL070129 |