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Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
NCT05649384 · View on ClinicalTrials.gov ↗
Study Summary
The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm
- DIAGNOSTIC_TEST European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm
Study Locations (20)
Other
- St Andrew's War Memorial Hospital Brisbane — Brisbane
- Vienna General Hospital (AKH Wien) — Vienna
- University Central Hospital Helsinki — Helsinki
- Attikon General Hospital Athens — Athens
- Careggi University Hospital Florence — Florence
- Azienda Ospedaliera San Giovanni Addolorata — Roma
- Hospital Città della Salute e della Scienza di Torino — Torino
- Emergency Institute for Cardiovascular Diseases C.C. Iliescu — Bucharest
- Konkuk University Medical Center — Seoul
- Hospital Clinic Barcelona — Barcelona
- University Hospital October 12 Madrid — Madrid
- University Hospital Ramon y Cajal — Madrid
- Hospital Clínico Universitario Valencia — Valencia
- Kantonsspital Aarau — Aarau
- St. Claraspital — Basel
- Kantonsspital Luzern — Lucerne
- University Hospital Zurich — Zurich
- Royal London Hospital — London
- Royal Cornwall Hospitals Treliske — Truro
Texas
- Baylor St. Luke's Medical Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64,374 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2028-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05649384
The ClinicalTrials.gov registry entry for NCT05649384 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64,374 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospital, Basel, Switzerland, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with NSTEMI - Non-ST Segment Elevation MI appearing as the primary indexed condition, and to 2 interventions — of which European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05649384 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05649384 about?
NCT05649384 is a clinical study titled "Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)". The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. ...
What is the current status of trial NCT05649384?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 64,374 participants. The study started on 2020-12-01. Estimated completion is 2028-05-31.
What conditions does trial NCT05649384 study?
This clinical trial studies the following conditions: NSTEMI - Non-ST Segment Elevation MI, Acute Chest Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05649384?
The interventions under investigation include: European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm (DIAGNOSTIC_TEST), European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05649384?
This trial is sponsored by University Hospital, Basel, Switzerland, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05649384 being conducted?
This trial has 20 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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