NCT03561051

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

6.2 years

First QC Date

June 6, 2018

Last Update Submit

April 30, 2024

Conditions

Keywords

T-MACSPre-hospital environment

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of acute myocardial infarction

    30 days

Secondary Outcomes (3)

  • Incident major adverse cardiac events

    30 days

  • Prevalent acute myocardial infarction

    30 days

  • Final diagnosis of participant

    30 days

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Bolton NHS Foundation Trust

Bolton, United Kingdom

Location

North West Ambulance Service NHS Trust

Bolton, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Location

West Midlands Ambulance Service NHS Foundation Trust

Dudley, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, United Kingdom

Location

South Western Ambulance Service NHS Foundation Trust

Exeter, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust

Taunton, United Kingdom

Location

South Warwickshire NHS Foundation Trust

Warwick, United Kingdom

Location

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, United Kingdom

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Chest PainAcute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Richard Body

    Manchester University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 19, 2018

Study Start

October 16, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations