Chest PainNCT03561051
The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
An observational study of Chest Pain and Acute Coronary Syndrome, run by Manchester University NHS Foundation Trust at 13 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Heart Attack
- How many people
- 700 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 16 Oct 2018to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Bolton NHS Foundation Trust
Bolton
North West Ambulance Service NHS Trust
Bolton
North Bristol NHS Trust
Bristol
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
West Midlands Ambulance Service NHS Foundation Trust
Dudley
Royal Devon and Exeter NHS Foundation Trust
Exeter
South Western Ambulance Service NHS Foundation Trust
Exeter
Manchester University NHS Foundation Trust
Manchester
Plymouth Hospitals NHS Trust
Plymouth
Salford Royal NHS Foundation Trust
Salford
Taunton and Somerset NHS Foundation Trust
Taunton
South Warwickshire NHS Foundation Trust
Warwick
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan
About this study
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.
Read the 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.
- Conditions
- Chest Pain, Acute Coronary Syndrome, Heart Attack
- Keywords
- T-MACS, Pre-hospital environment
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute myocardial infarction
Measured: 30 days
Secondary outcomes (3)
Incident major adverse cardiac events
Measured: 30 days
Prevalent acute myocardial infarction
Measured: 30 days
Final diagnosis of participant
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start16 Oct 2018
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- National Institute for Health Research, United Kingdom, Abbott Point of Care, LumiraDx, Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Richard Body, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561051
- Sponsor's protocol ID
- B00041
- Other IDs
- 223790
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2018
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilman J, Alghamdi A, Hann M, Carlton E, Cooper JG, Cook E, Siriwardena AN, Phillips J, Thompson A, Bell S, Kirby K, Rosser A, Body R. Diagnostic Accuracy of a Novel Point of Care High-Sensitivity Troponin Assay in the Prehospital Environment. Acad Emerg Med. 2026 Jan;33(1):e70213. doi: 10.1111/acem.70213.
PubMed 41528153Alghamdi A, Hann M, Carlton E, Cooper JG, Cook E, Foulkes A, Siriwardena AN, Phillips J, Thompson A, Bell S, Kirby K, Rosser A, Body R. Diagnostic Accuracy of Clinical Pathways for Suspected Acute Myocardial Infarction in the Out-of-Hospital Environment. Ann Emerg Med. 2023 Oct;82(4):439-448. doi: 10.1016/j.annemergmed.2023.04.010. Epub 2023 Jun 10.
PubMed 37306636Alghamdi 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.
PubMed 31662404
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
- ClinicalTrials.gov ID
- NCT03561051
- Acronym / sponsor ID
- B00041
- Conditions
- Chest Pain, Acute Coronary Syndrome, Heart Attack
- Keywords
- T-MACS, Pre-hospital environment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- National Institute for Health Research, United Kingdom, Abbott Point of Care, LumiraDx, Roche Diagnostics GmbH
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of acute myocardial infarction
Time frame: 30 days
3 secondary outcomes
Incident major adverse cardiac events
Time frame: 30 days
Prevalent acute myocardial infarction
Time frame: 30 days
Final diagnosis of participant
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 41528153Gilman J, Alghamdi A, Hann M, Carlton E, Cooper JG, Cook E, Siriwardena AN, Phillips J, Thompson A, Bell S, Kirby K, Rosser A, Body R. Diagnostic Accuracy of a Novel Point of Care High-Sensitivity Troponin Assay in the Prehospital Environment. Acad Emerg Med. 2026 Jan;33(1):e70213. doi: 10.1111/acem.70213.
- Derived from this study: PubMed 37306636Alghamdi A, Hann M, Carlton E, Cooper JG, Cook E, Foulkes A, Siriwardena AN, Phillips J, Thompson A, Bell S, Kirby K, Rosser A, Body R. Diagnostic Accuracy of Clinical Pathways for Suspected Acute Myocardial Infarction in the Out-of-Hospital Environment. Ann Emerg Med. 2023 Oct;82(4):439-448. doi: 10.1016/j.annemergmed.2023.04.010. Epub 2023 Jun 10.
- Derived from this study: PubMed 31662404Alghamdi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Body principal investigator
Manchester University NHS Foundation Trust
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Acute Coronary Syndrome, run by Manchester University NHS Foundation Trust at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of acute myocardial infarction (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03561051, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.