Pragmatic Randomised Trial of the ESC 0/1 Versus 0/3 Hour Troponin Pathway (MACROS2)
Acute Coronary Syndrome, Troponin, Chest Pain
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring acs, POC troponin, high sensitivity troponin
Eligibility Criteria
Inclusion Criteria:
- Chest pain with moderate or high suspicion chest pain (see chest pain evaluation chart at end) or any patient the clinician deems suspicious for myocardial ischaemia thus requesting a troponin sample (between daytime hours 0800hrs to 1800hrs)
- Presentation <12 hours since onset of chest pain (or unknown duration)
- Age >18 years of age
Exclusion Criteria:
- ST elevation myocardial infarction (STEMI) infarct on the presenting electrocardiogram (ECG)
- Symptoms considered definitely non-cardiac
- Trauma
- Pregnancy
- Comorbid conditions requiring hospital admission
- Coronary artery bypass graft surgery (CABG) <1 month
- coexistent clinical conditions likely to preclude follow-up.
Sites / Locations
- liverpool university Hospital nhs foundation trustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ESC 0/1 pathway
ESC 0/3 hour pathway
A two-arm parallel group, two-centre pragmatic randomised controlled trial of 0-1-hour high sensitivity troponin T (hs cTnT) compared to a 0-3-hour pathway as rules for rapid discharge of suspected ACS. (both incorporating single presentation sample limit of detection (LOD) high sensitive troponin as a rule for discharge, or cut-off selected by manufacturer). The power of the study is on safety rather than percent discharge achieved by 4 hours as this is the primary focus for clinicians and health care institutions. (By virtue of the earlier sampling the 0-1 hour troponin sampling is likely to allow greater discharges by 4 hours and the sample size for safety easily accommodates this aspect).
A two-arm parallel group, two-centre pragmatic randomised controlled trial of 0-1-hour high sensitivity troponin T (hs cTnT) compared to a 0-3-hour pathway as rules for rapid discharge of suspected ACS. (both incorporating single presentation sample limit of detection (LOD) high sensitive troponin as a rule for discharge, or cut-off selected by manufacturer). The power of the study is on safety rather than percent discharge achieved by 4 hours as this is the primary focus for clinicians and health care institutions. (By virtue of the earlier sampling the 0-1 hour troponin sampling is likely to allow greater discharges by 4 hours and the sample size for safety easily accommodates this aspect).