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Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest (FRONTEER)

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ClinicalTrials.gov Identifier: NCT03154879
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Kyu Nam Park, Seoul St. Mary's Hospital

Brief 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.

Condition or disease Intervention/treatment
Heart Arrest Device: Amplitude integrated electroencephalography

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Comatose cardiac arrest survivors Device: Amplitude integrated electroencephalography
Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5 [ 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.


  2. Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5 [ Time Frame: at day 180 ]

    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.


  3. Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5 [ Time Frame: at day 180 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Comatose cardiac arrest survivors treated with TH
Criteria

Inclusion Criteria:

  • age: 19 years and older
  • underwent TH

Exclusion Criteria:

  • Died within 72 h after cardiac arrest
  • Spontaneous or traumatic brain injury
  • Known history of neurological diseases (such as epilepsy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154879


Contacts
Contact: Sang Hoon Oh, MD 82-2-2258-1987 ohmytweety@catholic.ac.kr

Locations
Korea, Republic of
Samsung Changwon Hospital Recruiting
Changwon, Korea, Republic of
Contact: Yong Hwan Kim, MD         
Chonnam National University Recruiting
Gwangju, Korea, Republic of
Contact: Byung Kook Lee, MD         
Seoul St. Mary's hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Kyu Nam Park, MD    82-2-2258-1987    emsky@catholic.ac.kr   
KEPCO Medical Center Recruiting
Seoul, Korea, Republic of
Contact: In Soo Cho, MD         
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
Study Chair: Kyu Nam Park, MD Seoul St. Mary's Hospital

Responsible Party: Kyu Nam Park, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03154879     History of Changes
Other Study ID Numbers: 2017-CMC-07
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Web based Case Report Form

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kyu Nam Park, Seoul St. Mary's Hospital:
Heart arrest
Hypothermia
EEG
Prognosis

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases