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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Arrest
• Intervention / Treatment: Device: Amplitude integrated electroencephalography

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Sang Hoon Oh, MD; Phone Number: 82-2-2258-1987; Email: ohmytweety@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of
    • Recruiting
    • Samsung Changwon Hospital
    • Contact: Yong Hwan Kim, MD
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University
    • Contact: Byung Kook Lee, MD
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • Seoul st. mary's hospital
    • Contact: Kyu Nam Park, MD; Phone Number: 82-2-2258-1987; Email: emsky@catholic.ac.kr
  • Seoul, Korea, Republic of
    • Recruiting
    • KEPCO Medical Center
    • Contact: In Soo Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Comatose cardiac arrest survivors treated with TH

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at day 180
Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5		at day 180
Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5		at day 180
Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5		at day 180

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Investigators: Study Chair: Kyu Nam Park, MD, Seoul st. mary's hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 14, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Prognosis; EEG; Hypothermia; Heart arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2017-CMC-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Web based Case Report Form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes