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Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death

This study has been completed.
Information provided by:
University of Leipzig Identifier:
First received: February 8, 2010
Last updated: April 12, 2010
Last verified: January 2010
Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

Condition Intervention Phase
Cardiac Arrest
Device: Coolgard
Device: ArcticSun
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death

Resource links provided by NLM:

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • neuron specific enolase (NSE) as a parameter for cerebral damage [ Time Frame: 72 hours ]
    Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.

Secondary Outcome Measures:
  • neurologic outcome [ Time Frame: 6 months ]
    At 6 months after cardiac arrest, the cerebral performance category score is assessed to determine neurologic outcome.

  • time to overall survival [ Time Frame: one year ]
    At one year after cardiac arrest, overall survival of the cardiac arrest patients is assessed.

Enrollment: 108
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
invasive cooling
Device: Coolgard
invasive cooling via femoral ICY-catheter
Other Name: CG
non-invasive (surface) cooling
Device: ArcticSun
non-invasive surface cooling by saline-cooled thermo-vest
Other Name: AS

Detailed Description:
Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who survived sudden cardiac arrest and where treated with cooling-therapies

Inclusion Criteria:

  • ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia
  • GCS 3

Exclusion Criteria:

  • Non-cardiac sudden death
  • Pregnancy
  • Unstable circulation with high-dose inotropics
  • Life-expectancy reducing concomitant illness
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Please refer to this study by its identifier: NCT01102153

University of Leipzig, Heart Center, Cardiology
Leipzig, Germany, 04289
University of Leipzig, Heart Center, Cardiology
Leipzig, Germany
Sponsors and Collaborators
University of Leipzig
Principal Investigator: Holger Thiele, Associate Professor Study Chair
Study Director: Undine Pittl, MD Study Sub-Investigator
Study Director: Alexandra Schratter, MD Study Sub-Investigator
  More Information

Responsible Party: Holger Thiele, Assistant Professor, University of Leipzig, Heart Center Identifier: NCT01102153     History of Changes
Other Study ID Numbers: COOL-NSE
Study First Received: February 8, 2010
Last Updated: April 12, 2010

Keywords provided by University of Leipzig:
sudden cardiac arrest
arctic sun
neurological outcome
neuron specific enolase

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Death, Sudden processed this record on April 26, 2017