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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)
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)
Secondary ID [1] 0 0
2019-02269
Universal Trial Number (UTN)
Trial acronym
PRESC1SE-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Chest Pain 0 0
NSTEMI - Non-ST Segment Elevation MI 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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

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.

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.


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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Time from ED presentation to ED discharge or transfer
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Proportion of patients managed as outpatients
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Readmission for suspected AMI within 30 days after index presentation
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
All-cause mortality at 30 days in all patients
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
All-cause mortality at 365 days in all patients
Timepoint [4] 0 0
365 days
Secondary outcome [5] 0 0
New AMI (type1) at 30 days in all patients
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
New AMI (type 1) at 365 days in all patients
Timepoint [6] 0 0
365 days
Secondary outcome [7] 0 0
Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation
Timepoint [7] 0 0
365 days
Secondary outcome [8] 0 0
Satisfaction of patients with their evaluation in the ED
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
Treatment costs in the ED
Timepoint [9] 0 0
365 days
Secondary outcome [10] 0 0
Length of stay in the ED
Timepoint [10] 0 0
30 days
Secondary outcome [11] 0 0
Feasibility of the 0/1-hour algorithm
Timepoint [11] 0 0
80 minutes
Secondary outcome [12] 0 0
Effectiveness of rule-in
Timepoint [12] 0 0
30 days
Secondary outcome [13] 0 0
Effectiveness of rule-out
Timepoint [13] 0 0
30 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Terminal kidney failure requiring dialysis
* Cardiac arrest
* Cardiogenic shock

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
64374
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Andrew's War Memorial Hospital Brisbane - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Finland
State/province [3] 0 0
Helsinki
Country [4] 0 0
Greece
State/province [4] 0 0
Athens
Country [5] 0 0
Italy
State/province [5] 0 0
Florence
Country [6] 0 0
Italy
State/province [6] 0 0
Roma
Country [7] 0 0
Italy
State/province [7] 0 0
Torino
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Romania
State/province [9] 0 0
Bucharest
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Valencia
Country [13] 0 0
Switzerland
State/province [13] 0 0
Aarau
Country [14] 0 0
Switzerland
State/province [14] 0 0
Basel
Country [15] 0 0
Switzerland
State/province [15] 0 0
Luzern
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zürich
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Basel, Switzerland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Müller, MD Prof.
Address 0 0
University Hospital, Basel, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aura Winterhalder
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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