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Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03913065
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Region Skane
Charite University, Berlin, Germany
Halmstad County Hospital
Sahlgrenska University Hospital, Sweden
Karlstad Central Hospital
Medical University Innsbruck
University Hospital of Wales
Hopital Lariboisière
Nantes University Hospital
University Hospital, Linkoeping
Information provided by (Responsible Party):
Lund University

Brief Summary:

The European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) joint guidelines for post-resuscitation care recommend a multimodal approach to prognostication of neurological outcome.

However, head computed tomography (CT) which is commonly used for predicting long-term neurological outcome after cardiac arrest has not yet been examined prospectively in a clinical trial.

The primary purpose of the TTM-2 CT-substudy is to prospectively investigate and compare various methods of diagnosing generalized oedema on CT after cardiac arrest and it´s ability to predict long-term neurological outcome.


Condition or disease Intervention/treatment
Heart Arrest, Out-Of-Hospital Computed Tomography Unconsciousness Neurologic Deficits Diagnostic Test: CT

Detailed Description:

This study is a sub-study to the international multicenter Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM-2) Trial (ClinicalTrials.gov Identifier: NCT02908308).

All patients from participating centers still unconscious 48 hours after cardiac arrest will be routinely examined with CT. All other inclusion and exclusion criteria as well as treatment, neurological prognostication, withdrawal of life-sustaining therapy or follow-up will be handled according to TTM-2- protocol. Ethical approval for the main trial and this sub-study have been obtained from the Swedish Ethical Review Authority at Lund University (2015/228 and 2017/36). Both a patients´ next of kind or conscious patients have the opportunity to withdraw patients from the trial.

Pseudonymized original CT images will be uploaded to a two-way secured digital platform from Lund University (LUSEC). Two study radiologists blinded from clinical data will perform analyses according to protocol. Various methods of diagnosing generalized oedema will be investigated including eye-balling (oedema "yes"/"no"), as well as manual and automated measurements of the differentiation between the grey and white matter (GWR) by placing circular regions of interest (ROI). Primary outcome is the neurological outcome at 6 months after cardiac arrest using the modified Rankin Scale (mRS).

Secondary outcomes include neurocognitive outcomes such as the Glasgow Outcome Score-Extended version (GOS-E), Symbol-Digit-Modalities-Test (SDMT) and the Montreal Cognitive Assessment Score (MoCA).

The results of the radiological evaluations will also be correlated with other markers of neuronal injury such as biomarkers, clinical neurological information or neurophysiological examinations.

Additional analyses include evaluation of all available CT images of participating patients to investigate if there is any progression or regression of cerebral oedema.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy
Actual Study Start Date : November 18, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Included patients
Cardiac arrest patients from sites participating in the TTM-2 CT-substudy still unconscious 48 hours after cardiac arrest are routinely examined with head computed tomography as soon as possible after inclusion.
Diagnostic Test: CT
Head computed tomography on patients still unconscious 48 hours after cardiac arrest.Visual evaluation of generalized oedema ("eye-balling"). Manual and automated measurement of the differentiation of gray and white matter (GWR) using circular regions of interest (ROI).




Primary Outcome Measures :
  1. Poor functional outcome [ Time Frame: 180 days ]
    Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.


Secondary Outcome Measures :
  1. Exploratory: Neurocognitive outcome [ Time Frame: 180 days ]
    Montreal Cognitive Assessment Scale (MoCA)

  2. Exploratory: Neurocognitive outcome [ Time Frame: 180 days ]
    Symbol Digit Modalities Test (SDMT)

  3. Exploratory: Functional outcome [ Time Frame: 180 days ]
    Glasgow Outcome Scale-Extended version (GOS-E)


Biospecimen Retention:   Samples With DNA
Serum samples collected in the main trial TTM-2 (ClinicalTrials.gov Identifier: NCT02908308)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with Out-of hospital cardiac arrest included in the TTM-2 trial and randomized to either targeted temperature management at 33°C or early treatment of fever.
Criteria

Inclusion Criteria:

  • Out-of-hospital cardiac arrest
  • Presumed cardiac cause of cardiac arrest
  • Unconscious with a FOUR-score <M4 (not obeying verbal commands)
  • Stable return of spontaneous circulation (20 min)
  • Eligible for intensive care treatment without restrictions
  • Inclusion within 180 minutes of ROSC
  • Patient from participating centers, where head CT is routinely performed on all patients still unconscious 48 hours after cardiac arrest

Exclusion Criteria:

  • Unwitnessed cardiac arrest with an initial rhythm of asystole
  • Temperature on admission <30°C.
  • Obvious or suspected pregnancy
  • Intracranial bleeding
  • On ECMO prior to ROSC
  • Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
  • Patients from centers not participating in the TTM-2 CT-substudy
  • Patients from participating centers not examined with head CT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913065


Contacts
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Contact: Marion Moseby-Knappe, MD 0046 46171000 marion.moseby_knappe@med.lu.se
Contact: Tobias Cronberg, MD, PhD 0046 46171000 tobias.cronberg@skane.se

Locations
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Sweden
Marion Moseby-Knappe Recruiting
Lund, Skania, Sweden, 22185
Contact: Marion Moseby-Knappe, MD         
Principal Investigator: Niklas Nielsen, MD, PhD         
Principal Investigator: Hans Friberg, MD, PhD         
Principal Investigator: Johan Undén, MD, PhD         
Principal Investigator: Josef Dankiewicz, MD, PhD         
Principal Investigator: Christoph Leithner, MD, PhD         
Principal Investigator: Christian Storm, MD, PhD         
Principal Investigator: Christian Rylander, MD, PhD         
Sub-Investigator: Kasim Abul-Kasim, MD, PhD         
Principal Investigator: Matt P Wise, MD, DPhil         
Principal Investigator: Ola Borgquist, MD, PhD         
Principal Investigator: Victoria Sem, MD, PhD         
Principal Investigator: Nicolas Deye, MD, PhD         
Principal Investigator: Raimund Helbok, MD, PhD         
Principal Investigator: Thomas Halliday, MD, PhD         
Principal Investigator: Alain Cariou, MD, PhD         
Principal Investigator: Jean-Baptiste Lascarrou, MD, PhD         
Principal Investigator: Joachim Düring, MD, PhD         
Principal Investigator: Gisela Lilja, MD, PhD         
Principal Investigator: Tobias Cronberg, MD, PhD         
Sponsors and Collaborators
Lund University
Region Skane
Charite University, Berlin, Germany
Halmstad County Hospital
Sahlgrenska University Hospital, Sweden
Karlstad Central Hospital
Medical University Innsbruck
University Hospital of Wales
Hopital Lariboisière
Nantes University Hospital
University Hospital, Linkoeping
Investigators
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Principal Investigator: Marion Moseby-Knappe, MD Lund University and Skane University Hospitals Sweden
Principal Investigator: Tobias Cronberg, MD, PhD Lund University and Skane University Hospitals Sweden

Additional Information:
Publications of Results:
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03913065     History of Changes
Other Study ID Numbers: TTM-2 CT-substudy
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
Cardiac arrest
Hypothermia
Neurological function
Cardiovascular disease
Cerebral oedema
Cerebral edema
Cerebral ischaemia
Cerebral ischemia
Gray-white-matter differentiation
Grey-white-matter differentiation
ROI
Regions of interest
CT
GWR
Neurological prognostication
Additional relevant MeSH terms:
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Neurologic Manifestations
Unconsciousness
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Signs and Symptoms
Consciousness Disorders
Neurobehavioral Manifestations