DIagnostics, RBC Levels of n-3 Fatty Acids and Serum Vitamin D in Patients With Out-of-Hospital Cardiac Arrest (OHCA)
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Early diagnostic performance of copeptin in Out-of-Hospital Cardiac arrest (OHCA) due to ventricular fibrillation (VF)
研究概览
简要总结
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.
详细描述
Background:
Sudden cardiac death (SCD), also termed sudden cardiac arrest (SCA), accounts for approximately 15 percent of the total mortality in industrialized countries. In Europe, the incidence of out-of-hospital Emergency Medical Services (EMS) attended sudden cardiac arrest (SCA) is estimated to 81.6/100 000 person-years, 52.5 % of which is presumed to have a cardiac cause [1]. Coronary artery disease (CAD) is the most common underlying heart disease associated with out-of-hospital cardiac arrest (OHCA) [2]. SCD is the initial presentation of CAD in 15 percent of CAD-patients [3]. Furthermore, it is also the most frequent mechanism of death in patients with known CAD, accounting for 40-50 percent of CAD-mortality [4]. Compared to healthy subjects the incidence of SCD is six- to tenfold higher in the presence of clinically recognized heart disease [5], and cardiomyopathies represents the second largest cause of SCD [6]. Despite early advanced cardiopulmonary resuscitation (CPR) provided by the EMS the mortality rate remains high [1]. Due to the dramatic consequence of SCA, understanding of pathophysiological mechanisms and early identification of etiology is essential to improve outcome.
SCA due to VF may be the presenting symptom of acute myocardial ischemia or may be a consequence of scarring due to a previous myocardial infarction (MI). Cardiac troponin (c-Tn) is the most commonly used biomarker for diagnosing an acute myocardial infarction (AMI) [7]. Although earlier detection of AMI may be obtained by the introduction of high sensitivity (hs)-cTn assays, there still remains a troponin-blind period very early after symptom onset [8, 9], with the need for serial blood sampling to diagnose or exclude an AMI [7, 9]. Furthermore, there are challenges related to the specificity of elevated levels of hs-cTn [10, 11]. Therefore, measurement of hs-cTn in a single blood draw in the ambulance or at admission may not provide sufficient information for the diagnosis of AMI among patients with OHCA.
Lately, several studies have demonstrated an incremental diagnostic value of copeptin when added to conventional cTn or hs-cTn for early detection of AMI [12, 13]. Copeptin levels peak early (0-1 h) after symptom onset and are already increased at the time of first medical contact in the ambulance for patients with MI [8]. Copeptin used in combination with hs-cTn may therefore improve the diagnosis of AMI in very early presenters, and help differentiating the underlying cause of SCD.
Copeptin has also been demonstrated to be an independent predictor of adverse events following MI [14] and is shown to be associated with outcome after OHCA [15, 16]. Less is known about the prognostic value of troponins in patients experiencing a cardiac arrest (CA). Higher values of hs-cTnT are seen in one-year non-survivors as compared to survivors of OHCA, although not shown to be an independent predictor of 12-months survival [10]. In our study, the objective will be to evaluate the diagnostic and prognostic utility of hs-cTnT and copeptin in SCA patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •OHCA of assumed cardiac etiology
- •Documented first recorded heart rythm
排除标准
- •Evidence of non-cardiac death (including cerebral etiology and pulmonary embolism)
- •OHCA due to cardiac tamponade.
结局指标
主要结局
Early diagnostic performance of copeptin in Out-of-Hospital Cardiac arrest (OHCA) due to ventricular fibrillation (VF)
时间窗: 48 hours
Comparison with high sensitivity cardiac Troponin T.
次要结局
- Survival rate in OHCA with documented ventricular fibrillation(1 month)
- 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)
