Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

Heart Arrest Clinical Trial

— FRONTEER  

Official title:

Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03154879
• Other study ID #: 2017-CMC-07
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2017
• Last updated: May 14, 2017
• Start date: June 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2017
• Source: Seoul St. Mary's Hospital
• Contact: Sang Hoon Oh, MD
• Phone: 82-2-2258-1987
• Email: ohmytweety[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Device:
• Amplitude integrated electroencephalography
Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

Locations

Country	Name	City	State
Korea, Republic of	Samsung Changwon Hospital	Changwon
Korea, Republic of	Chonnam National University	Gwangju
Korea, Republic of	KEPCO Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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