title: Heart-type Fatty acid-binding protein in Acute Myocardial infarction Evaluation (FAME): background and design of a diagnostic study in primary care.
abstract: BACKGROUND
  Currently 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.
  
  
  METHODS
  Participating 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.
  
  
  CONCLUSIONS
  Reasons 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.
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands. m.h.e.bruinsslot@umcutrecht.nl
authors.forename: Madeleine H E
authors.initials: MH
authors.lastname: Bruins Slot
authors.forename: Geert J M G
authors.initials: GJ
authors.lastname: van der Heijden
authors.forename: Frans H
authors.initials: FH
authors.lastname: Rutten
authors.forename: Onno P
authors.initials: OP
authors.lastname: van der Spoel
authors.forename: E Gijs
authors.initials: EG
authors.lastname: Mast
authors.forename: Ad C
authors.initials: AC
authors.lastname: Bredero
authors.forename: Pieter A
authors.initials: PA
authors.lastname: Doevendans
authors.forename: Jan F C
authors.initials: JF
authors.lastname: Glatz
authors.forename: Arno W
authors.initials: AW
authors.lastname: Hoes
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D004562:Electrocardiography; D000074026:Fatty Acid Binding Protein 3; D050556:Fatty Acid-Binding Proteins / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000097:blood* / Q000175:diagnosis*; D012372:ROC Curve; D014336:Troponin / Q000097:blood
chemical_list: D015415:Biomarkers; C493408:FABP3 protein, human; D000074026:Fatty Acid Binding Protein 3; D050556:Fatty Acid-Binding Proteins; D014336:Troponin