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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT01102153
First received: February 8, 2010
Last updated: April 12, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Hypothermia
 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Coolgard
invasive cooling
 Device: Coolgard
invasive cooling via femoral ICY-catheter
Other Name: CG
ArcticSun
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who survived sudden cardiac arrest and where treated with cooling-therapies

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102153

Locations
Germany
University of Leipzig, Heart Center, Cardiology
Leipzig, Germany
University of Leipzig, Heart Center, Cardiology
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
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

Publications:

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

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

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Death, Sudden, Cardiac
Death
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013