Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05649384

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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Acute Chest Pain Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Disease Attributes Emergencies Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Andrew's War Memorial Hospital Brisbane, Brisbane, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 and above
  • Presentation with acute non-traumatic acute chest pain to the emergency department
  • Suspicion of acute myocardial infarction

Exclusion criteria

  • Terminal kidney failure requiring dialysis
  • Cardiac arrest
  • Cardiogenic shock

Treatment and study plan

European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm

Diagnostic Test

High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.

Other names: 0/1-hour algorithm

European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm

Diagnostic Test

High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.

Other names: 0/3-hour algorithm

Primary outcomes

  1. Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation

    Time frame: 30 days

    Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients

  2. Time from ED presentation to ED discharge or transfer

    Time frame: 30 days

    Length of stay in the ED measured in hours

Secondary outcomes

  1. Proportion of patients managed as outpatients

    Time frame: 24 hours

    Number of patients who stay in hospital for index event less than 24 hours

  2. Readmission for suspected AMI within 30 days after index presentation

    Time frame: 30 days

    Number of patients who stay in hospital for a new suspected AMI more than 24 hours within 30 days of index presentation

  3. All-cause mortality at 30 days in all patients

    Time frame: 30 days

    Number of deceased patients within 30 days after index presentation

  4. All-cause mortality at 365 days in all patients

    Time frame: 365 days

    Number of deceased patients within 365 days after index presentation

  5. New AMI (type1) at 30 days in all patients

    Time frame: 30 days

    Number of newly diagnosed AMI (type 1) in all patients within 30 days of index presentation

  6. New AMI (type 1) at 365 days in all patients

    Time frame: 365 days

    Number of newly diagnosed AMI (type 1) in all patients within 365 days of index presentation

  7. Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation

    Time frame: 365 days

    Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients

  8. Satisfaction of patients with their evaluation in the ED

    Time frame: 30 days

    Satisfaction will be measured on a numerical/visual analogue scale from 0-100%, the higher the score, the greater the satisfaction

  9. Treatment costs in the ED

    Time frame: 365 days

    Costs of procedures performed in the ED will be calculated according to national remuneration systems

  10. Length of stay in the ED

    Time frame: 30 days

    Length of stay from admission to the ED to discharge or transfer will be calculated according to national remuneration systems

  11. Feasibility of the 0/1-hour algorithm

    Time frame: 80 minutes

    Feasibility defined as the percentage of patients in whom the "1h" blood draw is performed within 1h +/- 20 minutes from the "0h" blood draw

  12. Effectiveness of rule-in

    Time frame: 30 days

    Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1)

  13. Effectiveness of rule-out

    Time frame: 30 days

    Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

PRospective Evaluation of the European Society of Cardiology 0/1-hour Algorithm's Safety and Efficacy for Triage of Patients With Suspected Myocardial Infarction (PRESC1SE-MI)

Acronym: PRESC1SE-MI

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Dec 14, 2022
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.