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

NCT01102153 | Completed

• 1 other identifier: COOL-NSE
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Arrest; Hypothermia

Keywords

sudden cardiac arrest; Hypothermia; Coolgard; arctic sun; neurological outcome; neuron specific enolase

Outcome Measures

Primary Outcomes (1)

• neuron specific enolase (NSE) as a parameter for cerebral damage

  Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.

  72 hours

Secondary Outcomes (2)

• neurologic outcome

  6 months

• time to overall survival

  one year

Study Arms (2)

Coolgard

invasive cooling

Device: Coolgard

ArcticSun

non-invasive (surface) cooling

Device: ArcticSun

Interventions

Coolgard DEVICE

invasive cooling via femoral ICY-catheter

Also known as: CG

Coolgard

ArcticSun DEVICE

non-invasive surface cooling by saline-cooled thermo-vest

Also known as: AS

ArcticSun

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• Non-cardiac sudden death
• Pregnancy
• Unstable circulation with high-dose inotropics
• Life-expectancy reducing concomitant illness

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (2)

University of Leipzig, Heart Center, Cardiology

Leipzig, 04289, Germany

Location

University of Leipzig, Heart Center, Cardiology

Leipzig, Germany

Location

Related Publications (2)

• Sulaj M, Saniova B, Drobna E, Schudichova J. Serum neuron specific enolase and malondialdehyde in patients after out-of-hospital cardiac arrest. Cell Mol Neurobiol. 2009 Sep;29(6-7):807-10. doi: 10.1007/s10571-009-9361-y. Epub 2009 Feb 25.

  PMID: 19241153 BACKGROUND

• Shinozaki K, Oda S, Sadahiro T, Nakamura M, Hirayama Y, Abe R, Tateishi Y, Hattori N, Shimada T, Hirasawa H. S-100B and neuron-specific enolase as predictors of neurological outcome in patients after cardiac arrest and return of spontaneous circulation: a systematic review. Crit Care. 2009;13(4):R121. doi: 10.1186/cc7973. Epub 2009 Jul 22.

  PMID: 19624826 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Hypothermia; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death; Pathologic Processes

Study Officials

• Holger Thiele, Associate Professor

  Study Chair

  PRINCIPAL INVESTIGATOR

• Undine Pittl, MD

  Study Sub-Investigator

  STUDY DIRECTOR

• Alexandra Schratter, MD

  Study Sub-Investigator

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 13, 2010

Record last verified: 2010-01

Locations

DE (2)