Heart ArrestMAEGICNCT03545828
Multi-channel aEEG in Cardiac Arrest Patients With Targeted Temperature Management
An observational study of Heart Arrest and Targeted Temperature Management, run by Sang Hoon Oh at 1 site in South Korea.
Trial summary
This study aims to examine the prognostic value of 18 channel amplitude-integrated EEG (aEEG) in comatose cardiac arrest patients The study design is a prospective observational study. Cardiac arrest patients undergoing targeted temperature management (TTM) will participate in the study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Arrest, Targeted Temperature Management
- What is being tested?
- Multi-channel aEEG monitoring
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 31 Dec 2019
- How long will I take part?
- 6 Months
- 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: TTM treated cardiac arrest patients
Who may be able to join
- Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring
Who cannot join
- Cerebral origin cardiac arrest Known epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurological Prognostication Using Multi-channel Amplitude-integrated Electroencephalographic Monitoring in Cardiac Arrest Patients With Targeted Temperature Management
This study aims to examine the prognostic value of 18 channel amplitude-integrated EEG (aEEG) in comatose cardiac arrest patients The study design is a prospective observational study. Cardiac arrest patients undergoing targeted temperature management (TTM) will participate in the study. Relation of aEEG in each channel with the neurologic outcome at 6 month after return of spontaneous circulation (ROSC) will be evaluated.
Read the detailed description
Normal trace was 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 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.
- Conditions
- Heart Arrest, Targeted Temperature Management
- Being tested
- Multi-channel aEEG monitoring
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-channel aEEG monitoringDiagnostic test
18 channel aEEG monitoring in comatose TTM-treated patients
| Study group | Role | What they receive |
|---|---|---|
| Good neurological outcome | CPC 1 and 2 at 6 month after ROSC Receives: Diagnostic Test: Multi-channel aEEG monitoring | |
| Poor neurological outcome | CPC 3 to 5 at 6 month after ROSC Receives: Diagnostic Test: Multi-channel aEEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to normal trace in each aEEG channel
Normal trace was 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 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.
Measured: at day 180
Secondary outcomes (3)
TTNT threshold for neurologic prognostication in each aEEG channel
Using area under the curve (AUC) of each channel aEEG for neurological outcome, we will determine the best TTNT thresholds for good neurological outcome (CPC 1 to 2) in all aEEG channels.
Measured: at day 180
Alpha delta ratio of each channel aEEG for good neurological outcome (CPC 1 to 2)
The percentage powers in the alpha, theta and delta bands and the ratio of the powers in different frequency bands (i.e., alpha/delta) will be calculated. Finally we will evaluate the prognostic values of these ratios of the different bands.
Measured: at day 180
Comparison of prognostic value between aEEG and various predictors
We will compare the prognostic performances (i.e., sensitivity, specificity, AUC) for poor neurological outcome (CPC 3 to 5) between EEG and these predictors.
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 posted4 Jun 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019 (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
- 78 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sang Hoon Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sang Hoon Oh, Seoul St. Mary's Hospital
- Investigators
- Sang Hoon Oh, Study director, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545828
- Sponsor's protocol ID
- MAEGIC-01
- Acronym
- MAEGIC
- Status last verified
- Sep 2019
- First submitted
- 22 Apr 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Prognostication Using Multi-channel Amplitude-integrated Electroencephalographic Monitoring in Cardiac Arrest Patients With Targeted Temperature Management
- ClinicalTrials.gov ID
- NCT03545828
- Acronym / sponsor ID
- MAEGIC / MAEGIC-01
- Conditions
- Heart Arrest, Targeted Temperature Management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Sang Hoon OhUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Jun 2018 (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.
This study aims to examine the prognostic value of 18 channel amplitude-integrated EEG (aEEG) in comatose cardiac arrest patients The study design is a prospective observational study. Cardiac arrest patients undergoing targeted temperature management (TTM) will participate in the study. Relation of aEEG in each channel with the neurologic outcome at 6 month after return of spontaneous circulation (ROSC) will be evaluated.
Detailed description
Normal trace was 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 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good neurological outcome | – | Diagnostic Test: Multi-channel aEEG monitoringCPC 1 and 2 at 6 month after ROSC |
| Poor neurological outcome | – | Diagnostic Test: Multi-channel aEEG monitoringCPC 3 to 5 at 6 month after ROSC |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TTM treated cardiac arrest patients
Key inclusion criteria (1 listed)
- Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring
Key exclusion criteria (1 listed)
- Cerebral origin cardiac arrest Known 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 |
|---|---|---|
| Multi-channel aEEG monitoring18 channel aEEG monitoring in comatose TTM-treated patients | Diagnostic test | Good neurological outcome, Poor neurological outcome |
Primary outcome
Time to normal trace in each aEEG channel
Time frame: at day 180
Normal trace was 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 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.
3 secondary outcomes
TTNT threshold for neurologic prognostication in each aEEG channel
Time frame: at day 180
Alpha delta ratio of each channel aEEG for good neurological outcome (CPC 1 to 2)
Time frame: at day 180
Comparison of prognostic value between aEEG and various predictors
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 26 Sep 2019.
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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.
Sang Hoon Oh study director
Seoul St. Mary's Hospital
1 site 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 and Targeted Temperature Management, run by Sang Hoon Oh at 1 site 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 1 inclusion and 1 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to normal trace in each aEEG channel (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 26 Sep 2019.