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

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ClinicalTrials.gov Identifier: NCT03561051
Recruitment Status : Not yet recruiting
First Posted : June 19, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Abbott Point of Care
LumiraDx
Roche Diagnostics
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease
Chest Pain Acute Coronary Syndrome Heart Attack

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
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Diagnosis of acute coronary syndromes [ Time Frame: 30 days ]
    Defined as prevalent acute myocardial infarction or incident major adverse cardiac events, which all cause death, coronary revascularisation and incident acute myocardial infarction


Secondary Outcome Measures :
  1. Prevalent acute myocardial infarction [ Time Frame: 30 days ]
  2. Final diagnosis of participant [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561051


Contacts
Contact: Senior Clinical Trials Coordinator 0161 701 7540 eloise.cook@mft.nhs.uk

Locations
United Kingdom
Bolton NHS Foundation Trust Not yet recruiting
Bolton, United Kingdom
Contact: Emergency Research Team         
North West Ambulance Service NHS Trust Not yet recruiting
Bolton, United Kingdom
Contact: Research Paramedic         
North Bristol NHS Trust Not yet recruiting
Bristol, United Kingdom
Contact: Emergency Research Team         
University Hospitals Coventry and Warwickshire NHS Trust Not yet recruiting
Coventry, United Kingdom
Contact: Emergency Research Team         
West Midlands Ambulance Service NHS Foundation Trust Not yet recruiting
Dudley, United Kingdom
Contact: Research Paramedic         
Royal Devon and Exeter NHS Foundation Trust Not yet recruiting
Exeter, United Kingdom
Contact: Emergency Research Team         
South Western Ambulance Service NHS Foundation Trust Not yet recruiting
Exeter, United Kingdom
Contact: Research Paramedic         
Manchester University NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom
Contact: Study Coordinator    0161 701 7540    eloise.cook@mft.nhs.uk   
Principal Investigator: Richard Body         
Pennine Acute Hospitals NHS Trust Not yet recruiting
Oldham, United Kingdom
Contact: Emergency Research Team         
Plymouth Hospitals NHS Trust Not yet recruiting
Plymouth, United Kingdom
Contact: Emergency Research Team         
Salford Royal NHS Foundation Trust Not yet recruiting
Salford, United Kingdom
Contact: Emergency Research Team         
University of North Midlands NHS Trust Not yet recruiting
Stoke, United Kingdom
Contact: Emergency Research Team         
Taunton and Somerset NHS Foundation Trust Not yet recruiting
Taunton, United Kingdom
Contact: Emergency Research Team         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
National Institute for Health Research, United Kingdom
Abbott Point of Care
LumiraDx
Roche Diagnostics
Investigators
Principal Investigator: Richard Body Manchester University NHS Foundation Trust

Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03561051     History of Changes
Other Study ID Numbers: B00041
223790 ( Other Identifier: IRAS Project ID )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manchester University NHS Foundation Trust:
T-MACS
Pre-hospital environment

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms