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DIagnostics, Fatty Acids and Vitamin D in SCA (DIFAD-SCA)

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ClinicalTrials.gov Identifier: NCT02886273
Recruitment Status : Active, not recruiting
First Posted : September 1, 2016
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:

Sudden cardiac death (SCD) is a major cause of mortality in industrialized countries and represents a major health issue. The survival rate after out-of-hospital cardiac arrest (OHCA) is only 10-15%, regardless of first recorded rhythm. Prior heart disease is a major risk factor for sudden cardiac arrest (SCA), and coronary artery disease (CAD) is the most common underlying cause. A better understanding of pathophysiological mechanisms occurring during cardiac arrest (CA), earlier diagnosis of underlying cause as well as identification of risk factors related to CA may improve patient treatment and increase survival. In our out-of-hospital cardiac arrest (OHCA)-study, we intend to investigate whether biomarkers, such as copeptin, hs-cTnT and NT-proBNP in addition to clinical evaluation may improve risk stratification and supply information related to pathophysiology.

Furthermore, we intend to gather additional pathophysiological information related to coagulation activation in CA and cardiopulmonary resuscitation (CPR), as intravascular thrombosis may impair microcirculation and reduce end-organ blood flow which is associated with a poor prognosis. We intend to study coagulation activation during and immediately after SCA with regard to outcome, and assess the contribution of the intrinsic system, measured together with that of the extrinsic system.

Low levels of n-3 fatty acids (FA) are reported as a risk factor for SCD. Red blood cell eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) may serve as a useful surrogate of cardiac omega-3 fatty acid status. The exact mechanism by which FAs might protect against serious cardiac arrhythmias is not known, but they are expected to exert a membrane stabilizing effect during an ischemic episode. In our study we intend to evaluate the association between ventricular fibrillation (VF) and the content of EPA and DHA in red blood cells. Furthermore, as vitamin D is associated with n-3 FAs in the diet, we also aim at investigating the association between 25-hydroxy (OH)-vitamin D and VF.


Condition or disease Intervention/treatment
Out-of-Hospital Cardiac Arrest Ventricular Fibrillation Other: Group 1 Other: Group 2 Other: Group 3 Other: Group 4

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: DIagnostics, RBC Levels of n-3 Fatty Acids and Serum Vitamin D in Patients With Out-of-Hospital Cardiac Arrest (OHCA)
Actual Study Start Date : January 2007
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : August 1, 2022


Group/Cohort Intervention/treatment
Group 1
SCA with first MI (n = 43)
Other: Group 1
Observation

Group 2
SCA with AMI and previous MI (n = 10)
Other: Group 2
Observation

Group 3
SCA without AMI and without former heart disease (n = 3)
Other: Group 3
Observation

Group 4
SCA without AMI and with known heart disease (n = 18)
Other: Group 4
Observation




Primary Outcome Measures :
  1. Early diagnostic performance of copeptin in Out-of-Hospital Cardiac arrest (OHCA) due to ventricular fibrillation (VF) [ Time Frame: 48 hours ]
    Comparison with high sensitivity cardiac Troponin T.


Secondary Outcome Measures :
  1. EPA and DHA as compared to other fatty acids in red blood cell membranes from patients with OHCA [ Time Frame: 48 hours ]
    Applying matched controls

  2. 25-hydroxy (OH)-vitamin D in subjects with OHCA due to ventricular fibrillation (VF) [ Time Frame: 48 hours ]
    Applying matched controls

  3. Survival rate in OHCA with documented ventricular fibrillation [ Time Frame: 1 month ]

Biospecimen Retention:   Samples Without DNA

20 ml of EDTA-blood for preparation of red blood cells and plasma will be harvested during resuscitation or immediately after return of spontaneous circulation (ROSC) from a peripheral venous catheter (PVC) or arterial line. After hospital admission blood samples will be collected from survivors according to general routines at our hospital. For survivors an extra set of blood samples consisting of 6 ml EDTA-blood, 6 ml citrate-blood and 6 ml serum will be taken after 8-12 hours and 24-48 hours.

All blood samples taken at inclusion will be immediately centrifuged and stored in aliquots at - 70o C until the measurements can be performed. Laboratory technicians will be blinded with respect to clinical data.



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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:   Non-Probability Sample
Study Population

Recruitment:

Patients with Out-of Hospital Cardiac Arrest (OHCA) of assumed cardiac origin will be recruited by the ambulance emergency team.

Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. OHCA of assumed cardiac etiology
  3. Documented first recorded heart rythm

Exclusion Criteria:

  1. Evidence of non-cardiac death (including cerebral etiology and pulmonary embolism)
  2. OHCA due to cardiac tamponade.

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): NCT02886273


Locations
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Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4011
Sponsors and Collaborators
Helse Stavanger HF
Investigators
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Principal Investigator: Dennis WT Nilsen, MDd PhD Helse Stavanger HF

Additional Information:

Publications of Results:
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02886273     History of Changes
Other Study ID Numbers: StavangerSCA
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Helse Stavanger HF:
Sudden Cardiac Arrest
Out-of-hospital
Ventricular fibrillation
Classification
Mechanisms
Biomarkers

Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents