Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol
ESC-TROP
1 other identifier
observational
16,000
1 country
5
Brief Summary
Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these patients undergo lengthy assessments in the ED or are admitted which contributes to ED and hospital crowding as well as a substantial health care burden. The now commonly used high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been observational. The safety and effectiveness of the protocol when implemented in routine care is thus unknown. The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedSeptember 11, 2019
September 1, 2019
11 months
January 21, 2018
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
AMI and all-cause death
Comparison of the rate of AMI and all-cause death within 30 days from ED presentation in patients discharged from the ED during the intervention period versus the control period (safety)
30 days from ED presentation
ED length of stay
Comparison of ED length of stay in patients discharged from the ED during the intervention period versus the control period (effectiveness)
Through discharge from the ED, on average 5 hours after ED presentation
Secondary Outcomes (8)
Proportion of ED patients discharged
Through discharge from the ED, on average 5 hours after ED presentation
Proportion of patients fulfilling 0h/1h hs-cTnT criteria who have undergone objective testing
30 days from ED presentation
Non-ACS coronary care unit admissions
Throughout index hospital visit, on average 2 days after ED presentation
Inappropriate coronary angiographies
Throughout index hospital visit, on average 2 days after ED presentation
Total hospital length of stay
Through discharge from the index hospital visit, on average 2 days after ED presentation
- +3 more secondary outcomes
Study Arms (2)
Intervention (Implementation) group
Chest pain patients enrolled during a 10 month period after a change in routine care, i.e. the implementation of a 0h/1h hs-cTnT protocol
Control group
Chest pain patients managed at the 3 intervention EDs during the corresponding 10 months of the previous year (intervention hospitals acting as their own controls) as well as chest pain patients managed during the corresponding before-and-after period at EDs not implementing the protocol (concurrent controls).
Interventions
Implementation of a 0h/1h hs-cTnT protocol in routine care
Eligibility Criteria
All ED patients with a primary complaint of chest pain will be screened for eligibility
You may qualify if:
- ED presentation with a primary complaint of non-traumatic chest pain
- Age ≥18 years
You may not qualify if:
- A final diagnosis of STEMI during the index visit
- No hs-cTnT ordered
- Patient leaving against medical advice
- No Swedish personal identification number
- Previous enrollment
- Unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulf Ekelundlead
- Region Skanecollaborator
- Lund Universitycollaborator
Study Sites (5)
Helsingborg General Hospital
Helsingborg, Sweden
Kristanstad Central Hospital
Kristianstad, Sweden
Skåne University Hospital
Lund, Sweden
Skåne University Hospital
Malmo, Sweden
Ystad Hospital
Ystad, Sweden
Related Publications (2)
Mokhtari A, Forberg JL, Sandgren J, Hard Af Segerstad C, Ellehuus C, Ekstrom U, Bjork J, Lindahl B, Khoshnood A, Ekelund U. Effectiveness and Safety of the ESC-TROP (European Society of Cardiology 0h/1h Troponin Rule-Out Protocol) Trial. J Am Heart Assoc. 2024 Nov 5;13(21):e036307. doi: 10.1161/JAHA.124.036307. Epub 2024 Oct 29.
PMID: 39470043DERIVEDGilje P, Mohammad MA, Roos A, Ekelund U, Bjork J, Lindahl B, Holzmann M, Mokhtari A. A Single High-Sensitivity Cardiac Troponin T Strategy for Ruling Out Myocardial Infarction. Emerg Med Int. 2024 Mar 25;2024:2241528. doi: 10.1155/2024/2241528. eCollection 2024.
PMID: 38567081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arash Mokhtari, MD, PhD
Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Department of Cardiology, Lund, Sweden
- PRINCIPAL INVESTIGATOR
Ulf Ekelund, MD, PhD
Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Lund, Sweden
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Professor of Emergency Medicine
Study Record Dates
First Submitted
January 21, 2018
First Posted
February 5, 2018
Study Start
February 1, 2018
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
September 11, 2019
Record last verified: 2019-09