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
• 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
• 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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Heart Attack
• Myocardial Infarction

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