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NCT03561051 Clinical Trial

The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study

Acute Coronary Syndrome Clinical Trial

Official title:
The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03561051
Other study ID # B00041
Secondary ID 223790
Status Active, not recruiting
Phase
First received
Last updated
Start date October 16, 2018
Est. completion date January 1, 2025

Study information
Verified date April 2024
Source Manchester University NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 700
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Bolton NHS Foundation Trust Bolton
United Kingdom North West Ambulance Service NHS Trust Bolton
United Kingdom North Bristol NHS Trust Bristol
United Kingdom University Hospitals Coventry and Warwickshire NHS Trust Coventry
United Kingdom West Midlands Ambulance Service NHS Foundation Trust Dudley
United Kingdom Royal Devon and Exeter NHS Foundation Trust Exeter
United Kingdom South Western Ambulance Service NHS Foundation Trust Exeter
United Kingdom Manchester University NHS Foundation Trust Manchester
United Kingdom Plymouth Hospitals NHS Trust Plymouth
United Kingdom Salford Royal NHS Foundation Trust Salford
United Kingdom Taunton and Somerset NHS Foundation Trust Taunton
United Kingdom South Warwickshire NHS Foundation Trust Warwick
United Kingdom Wrightington, Wigan and Leigh NHS Foundation Trust Wigan

Sponsors (5)
Lead Sponsor Collaborator
Manchester University NHS Foundation Trust Abbott Point of Care, LumiraDx, National Institute for Health Research, United Kingdom, Roche Diagnostics GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of acute myocardial infarction 30 days
Secondary Incident major adverse cardiac events 30 days
Secondary Prevalent acute myocardial infarction 30 days
Secondary Final diagnosis of participant 30 days
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