Heart ArrestFRONTEERNCT03154879
Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest
An observational study of Heart Arrest, run by Seoul St. Mary's Hospital at 4 sites in South Korea.
Trial summary
The investigators examine the prognostic value of continuous electroencephalography on frontal area of brain according to time by performing amplitude-integrated electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Amplitude integrated electroencephalography
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Jun 2017to 31 May 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Comatose cardiac arrest survivors treated with TH
Who may be able to join
- age: 19 years and older
- underwent TH
Who cannot join
- Died within 72 h after cardiac arrest
- Spontaneous or traumatic brain injury
- Known history of neurological diseases (such as epilepsy)
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Samsung Changwon Hospital
Changwon
Yong Hwan Kim, MD
- Recruiting
Chonnam National University
Gwangju
Byung Kook Lee, MD
- Recruiting
Seoul St. Mary's hospital
Seoul, 06591
Kyu Nam Park, MD, 82-2-2258-1987, emsky@catholic.ac.kr
- Recruiting
KEPCO Medical Center
Seoul
In Soo Cho, MD
About this study
Official title: Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia
The investigators examine the prognostic value of continuous electroencephalography on frontal area of brain according to time by performing amplitude-integrated electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.
- Conditions
- Heart Arrest
- Being tested
- Amplitude integrated electroencephalography
- Keywords
- Heart arrest, Hypothermia, EEG, Prognosis
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplitude integrated electroencephalographyDevice
Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest
| Study group | Role | What they receive |
|---|---|---|
| Comatose cardiac arrest survivors | Not described Receives: Device: Amplitude integrated electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2
Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation.
The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was >10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 uV.
Measured: at day 180
Secondary outcomes (5)
Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5
Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation.
The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was >10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 uV.
Measured: at day 180
Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5
Unfavorable aEEG patterns include flat trace (FT), burst-suppression (BS) and status epilepticus (SE).
FT is defined as isoelectric activity. BS is defined as the virtual absence of activity (<2uV) between bursts of high voltage (>25 uV).
SE was defined as repetitive epileptiform discharges with amplitudes >50 uV and a median frequency 1 Hz for >30 min.
Measured: at day 180
Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5
Measured: at day 180
Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5
Measured: at day 180
Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5
Measured: at day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Nam Park, Seoul St. Mary's Hospital
- Investigators
- Kyu Nam Park, MD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154879
- Sponsor's protocol ID
- 2017-CMC-07
- Acronym
- FRONTEER
- Status last verified
- May 2017
- First submitted
- 7 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Web based Case Report Form
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT03154879
- Acronym / sponsor ID
- FRONTEER / 2017-CMC-07
- Conditions
- Heart Arrest
- Keywords
- Heart arrest, Hypothermia, EEG, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 16 May 2017 (actual)
- 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 investigators examine the prognostic value of continuous electroencephalography on frontal area of brain according to time by performing amplitude-integrated electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comatose cardiac arrest survivors | – | Device: Amplitude integrated electroencephalography |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comatose cardiac arrest survivors treated with TH
Key inclusion criteria (2 listed)
- age: 19 years and older
- underwent TH
Key exclusion criteria (3 listed)
- Died within 72 h after cardiac arrest
- Spontaneous or traumatic brain injury
- Known history of neurological diseases (such as epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplitude integrated electroencephalographyFrontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest | Device | Comatose cardiac arrest survivors |
Primary outcome
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2
Time frame: at day 180
Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation. The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was >10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 uV.
5 secondary outcomes
Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5
Time frame: at day 180
Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5
Time frame: at day 180
Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5
Time frame: at day 180
Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5
Time frame: at day 180
Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5
Time frame: at day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: Yes. Web based Case Report Form
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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.
Kyu Nam Park, MD study chair
Seoul St. Mary's Hospital
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 Heart Arrest, run by Seoul St. Mary's Hospital at 4 sites in South Korea.
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 2 inclusion and 3 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 16 May 2017. 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 South Korea. 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 Sang Hoon Oh, MD (82-2-2258-1987, ohmytweety@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2 (time frame: at day 180). It is what the study was designed to measure, not a finding.
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 16 May 2017.