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

April 30, 2024 updated by: Manchester University NHS Foundation Trust
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of acute myocardial infarction
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incident major adverse cardiac events
Time Frame: 30 days
30 days
Prevalent acute myocardial infarction
Time Frame: 30 days
30 days
Final diagnosis of participant
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Collaborators

National Institute for Health Research, United Kingdom
Roche Diagnostics
Abbott Point of Care
LumiraDx

Investigators

  • Principal Investigator: Richard Body, Manchester University NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B00041
  • 223790 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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