Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

NSTEMI - Non-ST Segment Elevation MI Clinical Trial

— PRESC1SE-MI  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649384
• Other study ID #: 2019-02269
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Beate Hartmann, Msc PhD
• Email: Beate.Hartmann[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52156
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Chest Pain
• Chest Pain
• Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	St Andrew's War Memorial Hospital Brisbane	Brisbane
Austria	Vienna General Hospital (AKH Wien)	Wien
Finland	University Central Hospital Helsinki	Helsinki
Greece	Attikon General Hospital Athens	Athens
Italy	Careggi University Hospital Florence	Florence
Italy	Azienda Ospedaliera San Giovanni Addolorata	Roma
Italy	Hospital Città della Salute e della Scienza di Torino	Torino
Korea, Republic of	Konkuk University Medical Center	Seoul
Romania	Emergency Institute for Cardiovascular Diseases C.C. Iliescu	Bucharest
Spain	Hospital Clinic Barcelona	Barcelona
Spain	University Hospital October 12 Madrid	Madrid
Spain	University Hospital Ramon y Cajal	Madrid
Spain	Hospital Clínico Universitario Valencia	Valencia
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	St. Claraspital	Basel
Switzerland	Kantonsspital Luzern	Luzern
Switzerland	University Hospital Zurich	Zürich
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal London Hospital	London
United Kingdom	Royal Cornwall Hospitals Treliske	Truro
United States	Baylor St. Luke's Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Finland,  Greece,  Italy,  Korea, Republic of,  Romania,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation	Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients	30 days
Primary	Time from ED presentation to ED discharge or transfer	Length of stay in the ED measured in hours	30 days
Secondary	Proportion of patients managed as outpatients	Number of patients who stay in hospital for index event less than 24 hours	24 hours
Secondary	Readmission for suspected AMI within 30 days after index presentation	Number of patients who stay in hospital for a new suspected AMI more than 24 hours within 30 days of index presentation	30 days
Secondary	All-cause mortality at 30 days in all patients	Number of deceased patients within 30 days after index presentation	30 days
Secondary	All-cause mortality at 365 days in all patients	Number of deceased patients within 365 days after index presentation	365 days
Secondary	New AMI (type1) at 30 days in all patients	Number of newly diagnosed AMI (type 1) in all patients within 30 days of index presentation	30 days
Secondary	New AMI (type 1) at 365 days in all patients	Number of newly diagnosed AMI (type 1) in all patients within 365 days of index presentation	365 days
Secondary	Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation	Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients	365 days
Secondary	Satisfaction of patients with their evaluation in the ED	Satisfaction will be measured on a numerical/visual analogue scale from 0-100%, the higher the score, the greater the satisfaction	30 days
Secondary	Treatment costs in the ED	Costs of procedures performed in the ED will be calculated according to national remuneration systems	365 days
Secondary	Length of stay in the ED	Length of stay from admission to the ED to discharge or transfer will be calculated according to national remuneration systems	30 days
Secondary	Feasibility of the 0/1-hour algorithm	Feasibility defined as the percentage of patients in whom the "1h" blood draw is performed within 1h +/- 20 minutes from the "0h" blood draw	80 minutes
Secondary	Effectiveness of rule-in	Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1)	30 days
Secondary	Effectiveness of rule-out	Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease	30 days