Clinical trial NCT03561051: The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
Official title: The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chest Pain
Acute Coronary Syndrome
Heart Attack
Keywords: T-MACS
Pre-hospital environment
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: National Institute for Health Research, United Kingdom
name: Abbott Point of Care
name: LumiraDx
name: Roche Diagnostics GmbH
First posted: 2018-06-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will recruit patients who have called 999 with a complaint of pain, discomfort or pressure in the chest, who are then attended by an ambulance.

Brief summary: The aim of the study is to assess whether a decision aid that is currently used in hospitals across Greater Manchester to determine how likely it is that a patient has a serious heart problem is still accurate in the pre-hospital environment.

Detailed description: The Investigators will aim to recruit up to 700 participants, aged 18-100, who call 999 with a complaint of chest pain and are subsequently attended by the ambulance service. A blood sample will be taken in the ambulance as well as information about the participant's symptoms, past medical history, physical examination findings and heart tracing findings. The participant will then be transferred to hospital, where another blood sample will be taken. Both of these blood samples will be analysed at a later date for the cardiac marker, troponin.

Participants will then be followed up after 30 days via screening of their clinical records and contacting their GP. The investigators will gather information on the participant's initial admission to hospital, as well as any further hospital admissions and investigations that have occurred within the 30 days since this admission. The information collected will include data on serial cardiac marker testing; other laboratory analyses; length of stay; all imaging investigations and procedures; and details of any haemorrhagic complications.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years)
* Called 999 for an emergency ambulance because they have experienced pain, discomfort or pressure in the chest, epigastrium, neck, jaw or upper limb without an apparent non-cardiac source
* Treating paramedic suspects these symptoms may be caused by acute coronary syndromes.

Exclusion Criteria:

* Patients with unequivocal evidence of ST elevation myocardial infarction who are being immediately transferred for primary percutaneous coronary intervention
* Patients in whom an alternative diagnosis (other than acute coronary syndromes) is suspected, which would necessitate transfer to hospital
* Patients who have not experienced symptoms in the previous 24 hours
* Patients who lack the capacity to provide written informed consent, either because they lack the mental capacity to provide written informed consent or because effective communication is not possible (e.g. non-English speakers in the absence of adequate translation services)

Primary outcomes:
measure: Diagnosis of acute myocardial infarction
timeFrame: 30 days
Secondary outcomes:
measure: Incident major adverse cardiac events
timeFrame: 30 days
measure: Prevalent acute myocardial infarction
timeFrame: 30 days
measure: Final diagnosis of participant
timeFrame: 30 days
Other outcomes:
Locations:
city: Bolton
country: United Kingdom
facility: Bolton NHS Foundation Trust
city: Bolton
country: United Kingdom
facility: North West Ambulance Service NHS Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Dudley
country: United Kingdom
facility: West Midlands Ambulance Service NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: South Western Ambulance Service NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
city: Warwick
country: United Kingdom
facility: South Warwickshire NHS Foundation Trust
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Richard Body
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alghamdi A, Cook E, Carlton E, Siriwardena A, Hann M, Thompson A, Foulkes A, Phillips J, Cooper J, Bell S, Kirby K, Rosser A, Body R. PRe-hospital Evaluation of Sensitive TrOponin (PRESTO) Study: multicentre prospective diagnostic accuracy study protocol. BMJ Open. 2019 Oct 28;9(10):e032834. doi: 10.1136/bmjopen-2019-032834.