The PRESTO study
Research type
Research Study
Full title
The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) study
IRAS ID
223790
Contact name
Richard Body
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
When a patient calls emergency ambulance services for chest pain and the paramedic suspects it is due to a heart attack, the patient is taken to hospital. In the hospital the patient usually undergoes blood tests, both on arrival and up to 12 hours later before the diagnosis of heart attack can be excluded. With the best available laboratory-based tests for a biomarker called troponin, it may soon be possible to exclude this diagnosis as soon as 3 hours after arrival in the hospital. However, clinicians still have to wait for 1-2 hours for the results of laboratory-based tests. Point of care troponin tests are now available and could potentially be used in the ambulance. It is not known whether use of these point of care tests can exclude the diagnosis of a heart attack at the time of paramedic arrival to patients. If they could, we may be able to safely reduce the number of patients being taken to hospital and unnecessary hospital admissions.
We will invite patients who call an ambulance with symptoms of a possible heart attack to take part in this observational study. Of those patients who agree to take, the attending paramedic will take blood samples in the pre-hospital environment, which will be stored for later testing using point of care devices. This approach ensures that there is no change to the patient care pathway and that any urgent medical intervention is not disrupted. Once the patient has been admitted to the Emergency Department, we will take another blood sample 1 hour after the first. This will again be stored for testing at a later date. We will also collect clinical information about participants, which will include symptoms, previous history, clinical troponin results and electrical heart tracings or ECGs. Participants will be followed up at 30 days, after checking mortality status, to determine whether they have experienced any relevant clinical events after being discharged from the hospital. Due to the nature of the recruitment environment, paramedics will obtain verbal consent in the ambulance, which will then be followed up with informed written consent by the research staff in the hospital. The study database and samples will be pseudonymised, using only a unique study number to identify participants.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0101
Date of REC Opinion
11 Sep 2018
REC opinion
Further Information Favourable Opinion