Comparing two troponin testing pathways for chest pain assessment
Safety and Feasibility of Triage and Rapid Discharge of Patients With Chest Pain From Accident and Emergency: a Pragmatic, Randomised, Multicentre, Non-inferiority Control Trial of the Accelerated European Society of Cardiology (ESC) 0-1 Hour Pathway vs. Conventional 0-3 Hour Accelerated Diagnostic Protocol.
NA · Liverpool University Hospitals NHS Foundation Trust · NCT05322395
This study is testing if a quicker troponin testing method for chest pain can safely help patients leave the hospital sooner compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3536 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liverpool University Hospitals NHS Foundation Trust (other gov) |
| Locations | 1 site (Liverpool, GB) |
| Trial ID | NCT05322395 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and safety of implementing the ESC 0-1 hour high sensitivity troponin pathway compared to the conventional 0-3 hour pathway in patients presenting with chest pain. It will involve a randomized multicenter controlled design, assessing the percentage of safe discharges within 4 hours of presentation. The study will utilize high sensitivity troponin assays and will also explore point-of-care testing for additional insights into patient management. The primary focus is on ensuring patient safety while optimizing discharge protocols.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years presenting with chest pain and moderate to high suspicion of myocardial ischemia within 12 hours of symptom onset.
Not a fit: Patients with ST elevation myocardial infarction, non-cardiac symptoms, or those requiring hospital admission due to comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and safer discharge protocols for patients with chest pain, potentially improving outcomes in acute coronary syndrome management.
How similar studies have performed: Other studies have shown promise in using accelerated troponin pathways, but this specific comparison of the 0-1 hour versus 0-3 hour protocols is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chest pain with moderate or high suspicion chest pain (see chest pain evaluation chart at end) or any patient the clinician deems suspicious for myocardial ischaemia thus requesting a troponin sample (between daytime hours 0800hrs to 1800hrs) * Presentation \<12 hours since onset of chest pain (or unknown duration) * Age \>18 years of age Exclusion Criteria: * ST elevation myocardial infarction (STEMI) infarct on the presenting electrocardiogram (ECG) * Symptoms considered definitely non-cardiac * Trauma * Pregnancy * Comorbid conditions requiring hospital admission * Coronary artery bypass graft surgery (CABG) \<1 month * coexistent clinical conditions likely to preclude follow-up.
Where this trial is running
Liverpool, GB
- liverpool university Hospital nhs foundation trust — Liverpool, GB, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Aleem Khand
- Email: aleem.khand@liverpoolft.nhs.uk
- Phone: +441515292720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Coronary Syndrome, Troponin, Chest Pain, Point-of-care Systems, acs, POC troponin, high sensitivity troponin