Cardiac ArrestNCT01102153
Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death
An observational study of Cardiac Arrest and Hypothermia, run by University of Leipzig at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Hypothermia
- What is being tested?
- Coolgard and ArcticSun
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who survived sudden cardiac arrest and where treated with cooling-therapies
Who may be able to join
- ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia
- GCS 3
Who cannot join
- Non-cardiac sudden death
- Pregnancy
- Unstable circulation with high-dose inotropics
- Life-expectancy reducing concomitant illness
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Leipzig, Heart Center, Cardiology
Leipzig, 04289
University of Leipzig, Heart Center, Cardiology
Leipzig
About this study
Official title: NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death
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.
Read the 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.
- Conditions
- Cardiac Arrest, Hypothermia
- Being tested
- Coolgard, ArcticSun
- Keywords
- sudden cardiac arrest, Hypothermia, Coolgard, arctic sun, neurological outcome, neuron specific enolase
- Medical subject headings
- Heart Arrest, Hypothermia, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolgardDevice
Also called CG
invasive cooling via femoral ICY-catheter
ArcticSunDevice
Also called AS
non-invasive surface cooling by saline-cooled thermo-vest
| Study group | Role | What they receive |
|---|---|---|
| Coolgard | invasive cooling Receives: Device: Coolgard | |
| ArcticSun | non-invasive (surface) cooling Receives: Device: ArcticSun |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (2)
neurologic outcome
At 6 months after cardiac arrest, the cerebral performance category score is assessed to determine neurologic outcome.
Measured: 6 months
time to overall survival
At one year after cardiac arrest, overall survival of the cardiac arrest patients is assessed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Holger Thiele, Associate Professor, Principal investigator, Study ChairUndine Pittl, MD, Study director, Study Sub-InvestigatorAlexandra Schratter, MD, Study director, Study Sub-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102153
- Sponsor's protocol ID
- COOL-NSE
- Status last verified
- Jan 2010
- First submitted
- 8 Feb 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19241153Shinozaki 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.
PubMed 19624826
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death
- ClinicalTrials.gov ID
- NCT01102153
- Acronym / sponsor ID
- COOL-NSE
- Conditions
- Cardiac Arrest, Hypothermia
- Keywords
- sudden cardiac arrest, Hypothermia, Coolgard, arctic sun, neurological outcome, neuron specific enolase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coolgard | – | Device: Coolgardinvasive cooling |
| ArcticSun | – | Device: ArcticSunnon-invasive (surface) cooling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who survived sudden cardiac arrest and where treated with cooling-therapies
Key inclusion criteria (2 listed)
- ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia
- GCS 3
Key exclusion criteria (4 listed)
- Non-cardiac sudden death
- Pregnancy
- Unstable circulation with high-dose inotropics
- Life-expectancy reducing concomitant illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolgardAlso: CGinvasive cooling via femoral ICY-catheter | Device | Coolgard |
| ArcticSunAlso: ASnon-invasive surface cooling by saline-cooled thermo-vest | Device | ArcticSun |
Primary outcome
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.
2 secondary outcomes
neurologic outcome
Time frame: 6 months
time to overall survival
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
- Background: PubMed 19241153Sulaj 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.
- Background: PubMed 19624826Shinozaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Thiele, Associate Professor principal investigator
Study Chair
Undine Pittl, MD study director
Study Sub-Investigator
Alexandra Schratter, MD study director
Study Sub-Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Hypothermia, run by University of Leipzig at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuron specific enolase (NSE) as a parameter for cerebral damage (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2010.