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Norwegian Cardio-Respiratory Arrest Study (NORCAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01239420
Recruitment Status : Active, not recruiting
First Posted : November 11, 2010
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):
Espen Rostrup Nakstad, Oslo University Hospital

Brief Summary:
The purpose of this study is to evaluate the use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers in prognostication after cardio- and/or respiratory arrest.

Condition or disease
Cardiac Arrest Respiratory Arrest Coma

Detailed Description:

Cardiac arrest (CA) is a leading cause of death, affecting about 700.000 individuals each year in Europe. Acute Myocardial Infarction (AMI) and primary arrhythmia are the most common causes of CA, whereas respiratory arrest is a leading cause of secondary CA. Patients who have undergone cardiopulmonary resuscitation (CPR) often remain unconscious after hospital admission, either as a result of severe permanent brain damage or a merely reversible metabolic disturbance due to post-ischemic global reperfusion. Early prediction of neurological and cardiac outcome remains a difficult task for physicians. The decision to continue, limit or terminate intensive care therapy carries huge ethical and socioeconomic implications. Optimal emergency cardiovascular care, cardiac failure therapy and CA prevention after hospitalisation also remain difficult issues for cardiologists and intensive care doctors.

In this prospective study running from 2010, both prognostication and in-hospital treatment are studied in a population of 261 patients with out-of-hospital cardio-respiratory arrest. The use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers is studied to asses whether a poor neurological outcome (Cerebral Performance Category 3-5) can be predicted with ~100% specificity and a sensitivity that is sufficient for practical clinical use.

Pre-disposing and triggering causes of cardiorespiratory arrest are also registered. Patients with pre-existing conditions coherent with prophylactic ICD implementation under current international guidelines will be identified, in order to assess and further improve ICD-prophylactic treatment in Norway. The potential benefit of invasive PICCO-monitoring after CA will also be evaluated, and a subproject identifying biomarkers for CA risk has been established. NIRS (Near-Infrared spectroscopy) will also be used to register cerebral oxygenation in the early days after cardiorespiratory arrest.

The overall aim of the NORCAST study is to provide physicians with better tools to asses cardiac and neurological outcome as early and as accurate as possible.

All alive study patients are invited to long-term follow-up consultaions after 6 months, after 4 years, and after 10 years. The consultations will include study examinations, structured interviews and questionnaires. Questionnaires will also be used for next of kin.

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Study Type : Observational
Actual Enrollment : 261 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Norwegian Cardio-Respiratory Arrest Study (NORCAST)
Study Start Date : September 2010
Actual Primary Completion Date : August 2018
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Serum, plasma, blood (PaxGene). For future identification of biochemical markers in prognostication after cardiorespiratory arrest. For future identification of biochemical markers for cardiac arrest (primarily serum, but also on mRNA-level).

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
Patients admitted after pre-hospital cardio/respiratory arrest.

Inclusion Criteria:

  • prehospital cardial resuscitation
  • prehospital pulmonary resuscitation
  • ROSC before/on admission to hospital
  • > 18 years of age

Exclusion Criteria:

  • death on admission to hospital
  • arrhythmic cardiac arrest with ALS < 5min and spontaneous awakening
  • in-hospital cardiac arrest
  • trauma patients

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): NCT01239420

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Oslo University Hospital - Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
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Study Director: Dag Jacobsen, MD, PhD Oslo University Hospital - Ulleval, Norway
Study Director: Kjetil Sunde, MD, PhD Oslo University Hospital - Ulleval, Norway
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Espen Rostrup Nakstad, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01239420    
Other Study ID Numbers: REK S-O A Ref 2010/1116a
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases