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The primary objective of this study is to assess the feasibility and impact of implementing the ESC 0-1 hour high sensitive troponin pathway in clinical practice and with specific reference to the 0-3 hour pathway currently in use.
The principal outcome measure will be the safety of the 0-1 hour protocol (which is less established and has limited data on safety when implemented in clinical practice)
Full description
the investigators propose to compare 2 'gold standard' NICE recommended/ESC guideline-backed pathways; the accelerated 0-1 hour troponin clinical pathway versus the conventional 0-3-hour pathway, in a randomised multicentre controlled study.
Redundant blood sample will also be used to evaluate point of care testing (POCT), with additional blood sample taken for POC. These samples will be undertaken as part of routine clinical care and will not require additional venepuncture (and will only be analysed if consent is gained for tissue use in research) population. A co-primary endpoint will be single sample rule-out by point of care troponin (POCT) (with a value of <4ng/l in those with chest pain onset >3 hours from presentation) as assessed in the recent APACE study of triage true POC.11 A comparison of this rule-out in terms of effectiveness (percentage discharge) and safety (sensitivity) will be made with ROCHE lod (<5ng/l)12 and the optimised rule-out of Abbott architect (HSTNI<5ng/l)13
2.2 Secondary objectives
Means to test hypothesis: A two-arm parallel group, two-centre 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).
(Type 1 myocardial infarction is due to acute coronary atherothrombotic myocardial injury with either plaque rupture or erosion and, often, associated thrombosis. A separate analysis will also be undertaken with inclusion of type 2 MI as well as type 1 MI as an endpoint
4.2 Co-primary endpoint: There will be a comparison of the real time performance of point of care troponin (POCT) assay to that of a sample sent for analysis in the laboratory (the current gold standard of central laboratory analysis using HS cTn).The primary interest will be in presentation sample POC rule-out (triage true (quidel) POC <4ng/l with CP onset >3 hours compared to LOD or optimised rule-out of ROCHE (elecsys) assay, siemens attelica and Abbott architect. There will be a similar comparison made with siemens VTLI troponin I POC assay using FDA approved cut-points for MI rule-out
4.3 Secondary Endpoints:
Type 1 myocardial infarction (adjudicated with the use of Abbott hs cTnI) and cardiovascular death* at 4 weeks (target for safety negative predictive value (NPV) >99.5% and sensitivity >98%). (co-primary endpoint). This analysis will be repeated incorporating both type 1 and 2 MI definition. (prespecified secondary analysis)
All cause death, type 1 myocardial infarction and urgent or emergency revascularisation. This analysis will be repeated incorporating both type 1 and 2 MI definition. (prespecified secondary analysis)
Proportion with rule-out or rule-in MI in the 0-1 hour and 0-3 hour
Prediction of MI with myocardial ischemic injury index (MI3) algorithm9
HEART ≤3 and a modified HEART score for rule-out MI at 30 days15
Proportion with repeat presentations to accident and emergency within 30 days
Proportion undergoing coronary angiography and coronary revascularisation in 0-1 versus 0-3 hour pathway
Performance of point of care troponin samples at time points at 1 to 3 hours (additional samples to 0 hour) with respect to diagnosis of acute or chronic myocardial injury and/or type 1 myocardial infarction
Rule out of MI with GDF-15 (Growth Differentiation Factor 15)
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3,536 participants in 2 patient groups
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Ahmed Dakshi; Aleem Khand
Data sourced from clinicaltrials.gov
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