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Cracking Coma: Towards EEG and MRI Based Precision Medicine After Cardiac Arrest

NCT03308305 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2026-01-30

No results posted yet for this study

Summary

Rationale: 30-70% of comatose patients admitted to the intensive care unit (ICU) after cardiac arrest never regain consciousness as a result of post anoxic encephalopathy (PAE). Early identification of patients without potential for recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and patients. However, current diagnostic and prognostic measures can identify only 20-50% of the patients with irreversible brain damage, precluding cerebral recovery and awakening. Also, the pathophysiology of brain damage is largely unclear. New magnetic resonance imaging (MRI) sequences hold potential to substantially improve outcome prediction.

Objectives: 1. To estimate the additional value of early MRI monitoring for the prediction of neurological outcome of comatose patients after cardiac arrest. 2. To gain insight in the pathophysiology of PAE by associating MRI findings with histopathological studies of brain tissue obtained from non-survivors.

Study design: prospective cohort study.

Study population: 100 subsequent comatose patients after cardiac arrest, admitted to the ICU.

Intervention: In addition to standard treatments, patients will undergo MRI of the brain at day 3, 7, and three months after cardiac arrest. A subgroup of patients will be scanned within 24 hours after cardiac arrest, to assess feasibility and to gain more insight in the evolution of brain damage in PAE. Survivors will be followed for one year. Outcome measurements will focus on disabilities, quality of life, and depression. MRI measures will be related to outcome.

Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined as the score on the Cerebral Performance Category (CPC) at six months, dichotomized as good (CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe disability, coma, or death). Secondary outcome measures include cognitive functioning, depression, and quality of life at one year, as well as histopathological damage of brain tissue of non-survivors.

Conditions

  • Post-Anoxic Coma
  • Postanoxic Enchephalopathie

Sponsors & Collaborators

  • University Medical Center Nijmegen

    collaborator OTHER

  • Donders Centre for Cognitive Neuroimaging

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • J Hofmeijer, PhD · Rijnstate Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2025-11-01
Completion
2025-11-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308305 on ClinicalTrials.gov