Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT03561051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of acute myocardial infarction', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Incident major adverse cardiac events', 'timeFrame': '30 days'}, {'measure': 'Prevalent acute myocardial infarction', 'timeFrame': '30 days'}, {'measure': 'Final diagnosis of participant', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T-MACS', 'Pre-hospital environment'], 'conditions': ['Chest Pain', 'Acute Coronary Syndrome', 'Heart Attack']}, 'referencesModule': {'references': [{'pmid': '37306636', 'type': 'DERIVED', 'citation': 'Alghamdi 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.'}, {'pmid': '31662404', 'type': 'DERIVED', 'citation': 'Alghamdi 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 years)\n* 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\n* Treating paramedic suspects these symptoms may be caused by acute coronary syndromes.\n\nExclusion Criteria:\n\n* Patients with unequivocal evidence of ST elevation myocardial infarction who are being immediately transferred for primary percutaneous coronary intervention\n* Patients in whom an alternative diagnosis (other than acute coronary syndromes) is suspected, which would necessitate transfer to hospital\n* Patients who have not experienced symptoms in the previous 24 hours\n* 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)'}, 'identificationModule': {'nctId': 'NCT03561051', 'briefTitle': 'The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study', 'orgStudyIdInfo': {'id': 'B00041'}, 'secondaryIdInfos': [{'id': '223790', 'type': 'OTHER', 'domain': 'IRAS Project ID'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Bolton NHS Foundation Trust', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'North West Ambulance Service NHS Trust', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospitals Coventry and Warwickshire NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'West Midlands Ambulance Service NHS Foundation Trust', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'South Western Ambulance Service NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'city': 'Taunton', 'country': 'United Kingdom', 'facility': 'Taunton and Somerset NHS Foundation Trust', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'city': 'Warwick', 'country': 'United Kingdom', 'facility': 'South Warwickshire NHS Foundation Trust', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}, {'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Wrightington, Wigan and Leigh NHS Foundation Trust', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'Richard Body', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manchester University NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Abbott Point of Care', 'class': 'INDUSTRY'}, {'name': 'LumiraDx', 'class': 'INDUSTRY'}, {'name': 'Roche Diagnostics GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}