- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649384
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI) (PRESC1SE-MI)
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)
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brisbane, Australia
- St Andrew's War Memorial Hospital Brisbane
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Vienna, Austria
- Vienna General Hospital (AKH Wien)
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Helsinki, Finland
- University Central Hospital Helsinki
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Athens, Greece
- Attikon General Hospital Athens
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Florence, Italy
- Careggi University Hospital Florence
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Roma, Italy
- Azienda Ospedaliera San Giovanni Addolorata
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Torino, Italy
- Hospital Città della Salute e della Scienza di Torino
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Bucharest, Romania
- Emergency Institute for Cardiovascular Diseases C.C. Iliescu
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Seoul, South Korea
- Konkuk University Medical Center
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Barcelona, Spain
- Hospital Clinic Barcelona
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Madrid, Spain
- University Hospital Ramón y Cajal
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Madrid, Spain
- University Hospital October 12 Madrid
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Valencia, Spain
- Hospital Clínico Universitario Valencia
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Aarau, Switzerland
- Kantonsspital Aarau
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Basel, Switzerland
- St. Claraspital
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Lucerne, Switzerland
- Kantonsspital Luzern
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Zurich, Switzerland
- University Hospital Zurich
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London, United Kingdom
- Royal London Hospital
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Truro, United Kingdom
- Royal Cornwall Hospitals Treliske
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Texas
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Houston, Texas, United States, 77030
- Baylor St. Luke's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 0/1-hour algorithm
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.
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High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.
Other Names:
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Active Comparator: 0/3-hour algorithm
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.
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High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation
Time Frame: 30 days
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Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients
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30 days
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Time from ED presentation to ED discharge or transfer
Time Frame: 30 days
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Length of stay in the ED measured in hours
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of patients managed as outpatients
Time Frame: 24 hours
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Number of patients who stay in hospital for index event less than 24 hours
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24 hours
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Readmission for suspected AMI within 30 days after index presentation
Time Frame: 30 days
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Number of patients who stay in hospital for a new suspected AMI more than 24 hours within 30 days of index presentation
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30 days
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All-cause mortality at 30 days in all patients
Time Frame: 30 days
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Number of deceased patients within 30 days after index presentation
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30 days
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All-cause mortality at 365 days in all patients
Time Frame: 365 days
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Number of deceased patients within 365 days after index presentation
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365 days
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New AMI (type1) at 30 days in all patients
Time Frame: 30 days
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Number of newly diagnosed AMI (type 1) in all patients within 30 days of index presentation
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30 days
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New AMI (type 1) at 365 days in all patients
Time Frame: 365 days
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Number of newly diagnosed AMI (type 1) in all patients within 365 days of index presentation
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365 days
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Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation
Time Frame: 365 days
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Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients
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365 days
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Satisfaction of patients with their evaluation in the ED
Time Frame: 30 days
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Satisfaction will be measured on a numerical/visual analogue scale from 0-100%, the higher the score, the greater the satisfaction
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30 days
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Treatment costs in the ED
Time Frame: 365 days
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Costs of procedures performed in the ED will be calculated according to national remuneration systems
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365 days
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Length of stay in the ED
Time Frame: 30 days
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Length of stay from admission to the ED to discharge or transfer will be calculated according to national remuneration systems
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30 days
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Feasibility of the 0/1-hour algorithm
Time Frame: 80 minutes
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Feasibility defined as the percentage of patients in whom the "1h" blood draw is performed within 1h +/- 20 minutes from the "0h" blood draw
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80 minutes
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Effectiveness of rule-in
Time Frame: 30 days
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Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1)
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30 days
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Effectiveness of rule-out
Time Frame: 30 days
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Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease
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30 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Christian Müller, MD Prof., University Hospital, Basel, Switzerland
- Principal Investigator: Jasper Boeddinghaus, MD, University Hospital, Basel, Switzerland
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Chest pain
- Emergency department
- Unstable angina
- Myocardial Infarction MI
- ESC 0/1-hour algorithm
- Chest discomfort
- Acute Myocardial Infarction AMI
- Acute Coronary Syndrome ACS
- NSTEMI Non-ST-segment elevation myocardial infarction
- NSTE-ACS Non-ST-segment elevation acute coronary syndrome
- Damaged muscle of the heart
- Cardiac Biomarkers
- Cardiac Troponin T cTnT
- Cardiac-Specific Troponin T
- Cardiac Troponin I cTnI
- Cardiac-Specific troponin I
- Amount of troponin in the bloodstream
- Increased troponin level
- Elevated troponin level
- High troponin level
- Troponin assessment
- Measurement of troponin levels
- High-sensitive troponin test
- High-sensitivity troponin T testing
- High-sensitive Troponin T hsTnT
- cTnT-hs
- High-sensitive Troponin I hsTnI
- cTnI-hs
- High-sensitivity cardiac troponin assays
- ED presentation
- ED admission
- ED work-up
- Triage emergency department
- Triage emergency room
- Triage emergency hospital
- Rapid Rule-out of Acute Myocardial Infarction
- Shorter stay in the emergency department
- ESC 0/3-hour algorithm
- ESC Guidelines
- European Guidelines
- 0/1-hour algorithm
- 0/3-hour algorithm
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Disease Attributes
- Infarction
- Necrosis
- Myocardial Ischemia
- Ischemia
- Angina Pectoris
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Non-ST Elevated Myocardial Infarction
- Emergencies
- Myocardial Infarction
- Angina, Unstable
- Chest Pain
- Mathematical Concepts
- Algorithms
Other Study ID Numbers
- 2019-02269
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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