Biomarkers copeptin and high sensitive troponin versus standard care

• Research type

  Research Study

• Full title

  A single centre, study to compare the safety of a strategy using two biomarkers (copeptin and high sensitive troponin) versus standard care using a single biomarker ( High Sensitive Troponin) for the early rule-out of acute myocardial infarction (AMI) in patients with suspected acute coronary syndrome (ACS)

• IRAS ID

  193406

• Contact name

  Christopher Piers Clifford

• Contact email

  piers.clifford@buckshealthcare.nhs.uk

• Sponsor organisation

  Thermo Fisher Scientific

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  Adults who arrive at the emergency department at Stoke Mandeville Hospital (SMH) (Cohort 1) or the cardiac and stroke receiving unit at Wycombe General Hospital (Cohort 2), with signs and symptoms suggestive of a heart attach (Myocardial infarction (MI))and an intermediate-to low risk profile will have a blood sample drawn on admission.

  In cohort 2 after the patient has provided informed consent two blood proteins (Copeptin and cardiac Troponin)levels will be measured from this blood sample.

  For Cohort 1, the Copeptin blood result will not be available to the clinician and they will receive the usual standard of care, based on the troponin result. Then patients will be consented retrospectively.

  For Cohort 2, the results of these two tests (troponin/copeptin) will be used to define a 'rule out'for patients who are thought to be at low risk of heart attack, so that they can be discharged.

  The patients notes will be reviewed to find out
  • Accuracy of diagnosis of acute myocardial infarction
  • Accuracy of final hospital diagnoses
  • Time to discharge/transfer from the ED
  • Disposition decision (discharge or admission)
  • Length of hospital stay
  • ICU-treatment
  • Performance of Coronary angiography/ PCI/ CABG
  • Performance of stress testing
  • In-hospital all-cause mortality
  • One-month all-cause mortality

  These notes along with the Copeptin/Troponin results will be used for the study.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  16/SC/0198

• Date of REC Opinion

  23 May 2016

• REC opinion

  Further Information Favourable Opinion