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

• Sponsor: Seoul St. Mary's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03154879
• Collaborator: (none)
• Enrollment: 500
• Locations: 4
• Anticipated Duration (Months): 36
• Patients Per Site: 125
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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	Phase
Heart Arrest	Device: Amplitude integrated electroencephalography

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: May 31, 2020
• Anticipated Study Completion Date: May 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2 [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 [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 [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 [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 [at day 180]

5. Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5 [at day 180]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Changwon Hospital	Changwon		Korea, Republic of
2	Chonnam National University	Gwangju		Korea, Republic of
3	Seoul St. Mary's hospital	Seoul		Korea, Republic of	06591
4	KEPCO Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul St. Mary's Hospital

Investigators

• Study Chair: Kyu Nam Park, MD, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyu Nam Park, Professor, Seoul St. Mary's Hospital
• ClinicalTrials.gov Identifier: NCT03154879
• Other Study ID Numbers: 2017-CMC-07
• First Posted: May 16, 2017
• Last Update Posted: May 16, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Kyu Nam Park, Professor, Seoul St. Mary's Hospital: Heart arrest; Hypothermia; EEG; Prognosis
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of May 16, 2017