Cardiac ArrestCARESNCT00483873
Cardiac Arrest Recovery EEG Study
An observational study of Cardiac Arrest and Arrhythmia, run by Infinite Biomedical Technologies at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Arrhythmia
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital after out-of-hospital Cardiac arrest or for an ICD placement
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21187
Daniel F Hanley, MD, 410-614-6996, dhanley@jhmi.edu
Romergryko Geocadin, MD
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Romergryko Geocadin, MD
- Recruiting
Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
Milwaukee, Wisconsin, 53226
Michel Torbey, MD,MPH, 414-805-5343, mtorbey@mcw.edu
Michel Torbey, MD, MPH
- Not yet recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Mary Ann Peberdy, MD, 804-828-4571, mpeberdy@aol.com
Mary Ann Peberdy, MD
About this study
Official title: Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
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.
Read the 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
- Keywords
- Cardiac Arrest, Neurological Recovery, EEG, Quantitative EEG
- Medical subject headings
- Heart Arrest, Arrhythmias, Cardiac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startAug 2007
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infinite Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Medical College of Wisconsin, Virginia Commonwealth University
- Investigators
- Neil S Rothman, PhD, Principal investigator, Infinite Biomedical Technologies - Study SponsorRomergryko Geocadin, MD, Principal investigator, Johns Hopkins UniversityMichel Torbey, MD, MPH, Principal investigator, Medical College of WisconsinMary Ann Peberdy, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483873
- Sponsor's protocol ID
- R44HL070129
- Other IDs
- R44HL070129
- Acronym
- CARES
- Status last verified
- Jan 2009
- First submitted
- 6 Jun 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00483873
- Acronym / sponsor ID
- CARES / R44HL070129
- Conditions
- Cardiac Arrest, Arrhythmia
- Keywords
- Cardiac Arrest, Neurological Recovery, EEG, Quantitative EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Infinite Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Medical College of Wisconsin, Virginia Commonwealth University
- Study start
- Aug 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital after out-of-hospital Cardiac arrest or for an ICD placement
Key inclusion criteria (7 listed)
- Patients 18 years and older:
- Patients 18 years and older:
Key exclusion criteria (8 listed)
- 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
- Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
- CNS infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil S Rothman, PhD principal investigator
Infinite Biomedical Technologies - Study Sponsor
Romergryko Geocadin, MD principal investigator
Johns Hopkins University
Michel Torbey, MD, MPH principal investigator
Medical College of Wisconsin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Arrhythmia, run by Infinite Biomedical Technologies at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romergryko Geocadin, MD (410-614-6145, rgeocadi@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.