Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

NCT03154879 | Unknown DMC FDA Device

• 1 other identifier: 2017-CMC-07
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Arrest

Keywords

Heart arrest; Hypothermia; EEG; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5

  at day 180

• Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5

  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

Study Arms (1)

Comatose cardiac arrest survivors

Device: Amplitude integrated electroencephalography

Interventions

Amplitude integrated electroencephalography DEVICE

Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

Comatose cardiac arrest survivors

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Comatose cardiac arrest survivors treated with TH

You may qualify if:

• age: 19 years and older
• underwent TH

You may not qualify if:

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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (4)

Samsung Changwon Hospital

Changwon, South Korea

RECRUITING

Chonnam National University

Gwangju, South Korea

RECRUITING

Seoul St. Mary's hospital

Seoul, 06591, South Korea

RECRUITING

KEPCO Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyu Nam Park, MD

  Seoul St. Mary's Hospital

  STUDY CHAIR

Central Study Contacts

Sang Hoon Oh, MD

CONTACT

82-2-2258-1987; ohmytweety@catholic.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 16, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (4)