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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
Date last updated
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
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
Duration
Selection
Timing
Prospective
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
30/09/2025
Actual
Sample size
Target
52156
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
Leicester
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Truro

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05649384
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
Beate Hartmann, Msc PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05649384