DIagnostics, Fatty Acids and Vitamin D in SCA

NCT02886273 | Unknown

• 1 other identifier: StavangerSCA
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation

Keywords

Sudden Cardiac Arrest; Out-of-hospital; Ventricular fibrillation; Classification; Mechanisms; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Early diagnostic performance of copeptin in Out-of-Hospital Cardiac arrest (OHCA) due to ventricular fibrillation (VF)

  Comparison with high sensitivity cardiac Troponin T.

  48 hours

Secondary Outcomes (3)

• EPA and DHA as compared to other fatty acids in red blood cell membranes from patients with OHCA

  48 hours

• 25-hydroxy (OH)-vitamin D in subjects with OHCA due to ventricular fibrillation (VF)

  48 hours

• Survival rate in OHCA with documented ventricular fibrillation

  1 month

Study Arms (4)

Group 1

SCA with first MI (n = 43)

Other: Group 1

Group 2

SCA with AMI and previous MI (n = 10)

Other: Group 2

Group 3

SCA without AMI and without former heart disease (n = 3)

Other: Group 3

Group 4

SCA without AMI and with known heart disease (n = 18)

Other: Group 4

Interventions

Group 1 OTHER

Observation

Group 1

Group 2 OTHER

Observation

Group 2

Group 3 OTHER

Observation

Group 3

Group 4 OTHER

Observation

Group 4

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• OHCA of assumed cardiac etiology
• Documented first recorded heart rythm

You may not qualify if:

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

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4011, Norway

Location

Related Publications (4)

• Aarsetoy R, Omland T, Rosjo H, Strand H, Lindner T, Aarsetoy H, Staines H, Nilsen DWT. N-terminal pro-B-type natriuretic peptide as a prognostic indicator for 30-day mortality following out-of-hospital cardiac arrest: a prospective observational study. BMC Cardiovasc Disord. 2020 Aug 24;20(1):382. doi: 10.1186/s12872-020-01630-x.

  PMID: 32838754 BACKGROUND

• Aarsetoey H, Aarsetoey R, Lindner T, Staines H, Harris WS, Nilsen DW. Low levels of the omega-3 index are associated with sudden cardiac arrest and remain stable in survivors in the subacute phase. Lipids. 2011 Feb;46(2):151-61. doi: 10.1007/s11745-010-3511-3. Epub 2011 Jan 14.

  PMID: 21234696 RESULT

• Aarsetoy R, Aarsetoy H, Hagve TA, Strand H, Staines H, Nilsen DWT. Initial Phase NT-proBNP, but Not Copeptin and High-Sensitivity Cardiac Troponin-T Yielded Diagnostic and Prognostic Information in Addition to Clinical Assessment of Out-of-Hospital Cardiac Arrest Patients With Documented Ventricular Fibrillation. Front Cardiovasc Med. 2018 Jun 7;5:44. doi: 10.3389/fcvm.2018.00044. eCollection 2018.

  PMID: 29930943 RESULT

• Aarsetoy R, Ten Cate H, Spronk H, Van Oerle R, Aarsetoy H, Staines H, Nilsen DWT. Activated factor XI-antithrombin complex presenting as an independent predictor of 30-days mortality in out-of-hospital cardiac arrest patients. Thromb Res. 2021 Aug;204:1-8. doi: 10.1016/j.thromres.2021.05.014. Epub 2021 May 29.

  PMID: 34089982 DERIVED

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.

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death

Study Officials

• Dennis WT Nilsen, MDd PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 1, 2016
• Study Start: January 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)