Abstract
BackgroundCurrently used biomarkers for cardiac ischemia are elevated in blood plasma after a delay of several hours and therefore unable to detect acute coronary syndrome (ACS) in a very early stage. General practitioners (GPs), however, are often confronted with patients suspected of ACS within hours after onset of complaints. This ongoing study aims to evaluate the added diagnostic value beyond clinical assessment for a rapid bedside test for heart-type fatty-acid binding protein (H-FABP), a biomarker that is detectable as soon as one hour after onset of ischemia.MethodsParticipating GPs perform a blinded H-FABP rapid bedside test (Cardiodetect®) in patients with symptoms suggestive of ACS such as chest pain or discomfort at rest. All patients, whether referred to hospital or not, undergo electrocardiography (ECG) and venapunction for a plasma troponin test within 12–36 hours after onset of complaints. A final diagnosis will be established by an expert panel consisting of two cardiologists and one general practitioner (blinded to the H-FABP test result), using all available patient information, also including signs and symptoms. The added diagnostic value of the H-FABP test beyond history taking and physical examination will be determined with receiver operating characteristic curves derived from multivariate regression analysis.ConclusionReasons for presenting the design of our study include the prevention of publication bias and unacknowledged alterations in the study aim, design or data-analysis. To our knowledge this study is the first to assess the diagnostic value of H-FABP outside a hospital-setting. Several previous hospital-based studies showed the potential value of H-FABP in diagnosing ACS. Up to now however it is unclear whether these results are equally promising when the test is used in primary care. The first results are expected in the end of 2008.
Highlights
Used biomarkers for cardiac ischemia are elevated in blood plasma after a delay of several hours and unable to detect acute coronary syndrome (ACS) in a very early stage
Troponin is the biomarker of choice according to European and American guidelines on myocardial infarction
Troponin is elevated only 6–9 hours after onset of ischemia [1,4,5], while most patients with symptoms suggestive of ACS present themselves to the General practitioners (GPs) between 1 and 3 hours after symptom onset [6,7,8]; hours before troponin can be used to accurately exclude or confirm acute myocardial infarction (AMI)
Summary
Used biomarkers for cardiac ischemia are elevated in blood plasma after a delay of several hours and unable to detect acute coronary syndrome (ACS) in a very early stage. General practitioners (GPs), are often confronted with patients suspected of ACS within hours after onset of complaints. This ongoing study aims to evaluate the added diagnostic value beyond clinical assessment for a rapid bedside test for heart-type fatty-acid binding protein (H-FABP), a biomarker that is detectable as soon as one hour after onset of ischemia. The GP will assess these patients using history taking and physical examination only With these limited tools it is notoriously difficult to accurately rule out or rule in ACS, notably in women and elderly patients in whom signs and symptoms of ACS can be rather atypical [3]. Troponin is elevated only 6–9 hours after onset of ischemia [1,4,5], while most patients with symptoms suggestive of ACS present themselves to the GP between 1 and 3 hours after symptom onset [6,7,8]; hours before troponin can be used to accurately exclude or confirm AMI
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