Pragmatic RCT of the ESC 0/1 versus 0/3 hour pathways
Research type
Research Study
Full title
Enhancing percentage safe discharge by 4 hours following presentation with suspected acute coronary syndrome: a pragmatic randomised control trial of the ESC 1 hour and 3 hour accelerated protocols
IRAS ID
287190
Contact name
Aleem Khand
Contact email
Sponsor organisation
Liverpool University Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Each year approximately 1.5 million patients present to accident and emergency departments in England and Wales with chest pain. However less than 1 in 8 are suffering from a heart attack. The priority for doctors is to determine which patients are in the throes of a heart attack or who may imminently suffer one and those patients with no serious condition that could be safely discharged. This is important as it allow doctors to focus treatment on those suffering a heart attack, prevent harm associated with admission to hospital, such as an infection, to those with no serious underlying condition and allow the entire hospital to operate more efficiently.
Differentiating patients with or without a heart attack is not always easy. It requires looking at a number of different pieces of information including the description of the chest pain, the ECG (electrical recording of the heart) and blood tests measuring troponin (a protein released in the blood indicating heart damage which is usually, but not always, as a consequence of a heart attack). The current practise in Liverpool university hospital foundation trust is to take a blood sample when the patient presents to accident and emergency and then to repeat this after 3 hours. If there is a rise or fall in troponin levels, then the patient is likely to have suffered a heart attack. However, it is also possible to repeat the test at 1 hour rather than 3 hours. The advantage of this is potentially shortening the patients stay in the emergency department. Recent evidence suggests that this is just as safe (repeating the sample at 1 hour rather than 3 hours) and can allow safe discharge of more patients. The evidence has persuaded the European Society of Cardiology to include this in their 2020 guidelines.
However, what is not clear is how well this new pathway (the 0/1 hour pathway- taking a blood sample at presentation and after 1 hour) works in practice in a busy and stressfuldepartment. It is possible that the repeat sample at 1 hour would be too difficult to work in practice. It could also be the case that in real world conditions the accuracy (or rather precision) of the troponin results are not as good as the research studies suggest. We aim to find out.
Our study purpose is to introduce the 0/1-hour pathway in Liverpool university hospital foundation trust, which is approved for use, but at the same time to understand if, in practice, it performs better than the current 0/3 hour pathway being used.
We aim to do this by alternating between the 2 pathways and to determine what works best in practice. This is a practice we have decided to undertake as part of the gradual introduction of a new pathway that is already recognized
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0202
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion