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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05649384
Registration number
NCT05649384
Ethics application status
Date submitted
14/11/2022
Date registered
14/12/2022
Titles & IDs
Public title
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
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Scientific 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)
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Secondary ID [1]
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2019-02269
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Universal Trial Number (UTN)
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Trial acronym
PRESC1SE-MI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Chest Pain
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NSTEMI - Non-ST Segment Elevation MI
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm
Diagnosis / Prognosis - European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm
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.
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.
Diagnosis / Prognosis: European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.
Diagnosis / Prognosis: European Society of Cardiology hs-cTnT/I 0 h/3 h 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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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation
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Assessment method [1]
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Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients
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Timepoint [1]
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30 days
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Primary outcome [2]
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Time from ED presentation to ED discharge or transfer
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Assessment method [2]
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Length of stay in the ED measured in hours
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Timepoint [2]
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30 days
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Secondary outcome [1]
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Proportion of patients managed as outpatients
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Assessment method [1]
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Number of patients who stay in hospital for index event less than 24 hours
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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Readmission for suspected AMI within 30 days after index presentation
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Assessment method [2]
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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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Timepoint [2]
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30 days
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Secondary outcome [3]
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All-cause mortality at 30 days in all patients
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Assessment method [3]
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Number of deceased patients within 30 days after index presentation
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Timepoint [3]
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30 days
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Secondary outcome [4]
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All-cause mortality at 365 days in all patients
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Assessment method [4]
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Number of deceased patients within 365 days after index presentation
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Timepoint [4]
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365 days
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Secondary outcome [5]
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New AMI (type1) at 30 days in all patients
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Assessment method [5]
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Number of newly diagnosed AMI (type 1) in all patients within 30 days of index presentation
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Timepoint [5]
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30 days
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Secondary outcome [6]
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New AMI (type 1) at 365 days in all patients
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Assessment method [6]
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Number of newly diagnosed AMI (type 1) in all patients within 365 days of index presentation
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Timepoint [6]
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365 days
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Secondary outcome [7]
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Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation
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Assessment method [7]
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Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients
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Timepoint [7]
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365 days
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Secondary outcome [8]
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Satisfaction of patients with their evaluation in the ED
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Assessment method [8]
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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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Timepoint [8]
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30 days
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Secondary outcome [9]
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Treatment costs in the ED
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Assessment method [9]
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Costs of procedures performed in the ED will be calculated according to national remuneration systems
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Timepoint [9]
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365 days
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Secondary outcome [10]
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Length of stay in the ED
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Assessment method [10]
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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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Timepoint [10]
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30 days
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Secondary outcome [11]
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Feasibility of the 0/1-hour algorithm
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Assessment method [11]
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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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Timepoint [11]
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80 minutes
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Secondary outcome [12]
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Effectiveness of rule-in
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Assessment method [12]
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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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Timepoint [12]
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30 days
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Secondary outcome [13]
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Effectiveness of rule-out
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Assessment method [13]
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Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease
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Timepoint [13]
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30 days
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Eligibility
Key inclusion criteria
* Patients aged 18 and above
* Presentation with acute non-traumatic acute chest pain to the emergency department
* Suspicion of acute myocardial infarction
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Terminal kidney failure requiring dialysis
* Cardiac arrest
* Cardiogenic shock
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
52156
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Andrew's War Memorial Hospital Brisbane - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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Austria
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State/province [2]
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Wien
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Country [3]
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Finland
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State/province [3]
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Helsinki
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Country [4]
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Greece
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State/province [4]
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Athens
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Country [5]
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Italy
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State/province [5]
0
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Florence
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Country [6]
0
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Italy
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State/province [6]
0
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Roma
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Country [7]
0
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Italy
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State/province [7]
0
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Torino
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Country [8]
0
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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Romania
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State/province [9]
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Bucharest
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Country [10]
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Spain
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State/province [10]
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Barcelona
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Country [11]
0
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Spain
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State/province [11]
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Madrid
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Country [12]
0
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Spain
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State/province [12]
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Valencia
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Country [13]
0
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Switzerland
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State/province [13]
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Aarau
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Country [14]
0
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Switzerland
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State/province [14]
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Basel
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Country [15]
0
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Switzerland
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State/province [15]
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Luzern
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Country [16]
0
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Switzerland
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State/province [16]
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Zürich
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Country [17]
0
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United Kingdom
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State/province [17]
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Leicester
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Country [18]
0
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United Kingdom
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State/province [18]
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London
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Country [19]
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United Kingdom
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State/province [19]
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Truro
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital, Basel, Switzerland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05649384
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christian Müller, MD Prof.
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Address
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University Hospital, Basel, Switzerland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Beate Hartmann, Msc PhD
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Address
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Country
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05649384