Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol (ESC-TROP)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Chest Pain; Acute Coronary Syndrome; Unstable Angina
• Intervention / Treatment: Other: 0h/1h hs-cTnT protocol

Detailed Description

STUDY DESIGN:

ESC-TROP is a before-and-after implementation study with concurrent controls that will evaluate the safety and effectiveness of a 0h/1h hs-cTnT protocol. The intervention group will consist of ED chest pain patients enrolled during 10 months after implementation of this protocol in routine care at the three intervention sites, and the control groups will be chest pain patients managed at the same EDs during the corresponding 10 months of the previous year, as well as chest pain patients managed during the same before-and-after period at two EDs not implementing the protocol (concurrent controls).

OBJECTIVES:

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.

ELIGIBILITY CRITERIA:

All patients with an ED visit with a primary complaint of non-traumatic chest pain will be identified through the electronic ED patient log and screened for eligibility.

IMPLEMENTED PROTOCOL:

ESC guidelines state that the 0h/1h hs-cTnT protocol should be used in conjunction with clinical assessment and the ECG, and these items are therefore incorporated in the protocol, which also reflects real-life practice. A 1h hs-cTnT is defined as a second hs-cTnT sample drawn 45 - 90 minutes from the sample at presentation (0h).

OUTCOMES:

Se outcomes section. Outcomes will be compared in the 10-month periods before and after the implementation at all five hospitals, and the differences in change will be compared between intervention and control hospitals.

FOLLOW-UP:

Follow-up will be performed using data from a comprehensive regional electronic patient record system as well as Swedish national registries.

DATA MANAGEMENT AND STATISTICAL ANALYSES:

Data management and statistical analyses will be performed by Clinical Studies Sweden, Forum South. For the primary safety outcome, event rate after implementation (intervention group) will be compared to event rate in the control period using a non-inferiority approach

SAMPLE SIZE:

If it is assumed that the event rate is 0.4% among discharged patients in the control period and 0.5% after implementation, 4396 discharged patients would be needed both before and after the implementation (i.e. a total of 8792) to statistically determine that the event rate after implementation is non-inferior to that in the control period, with a two-sided alpha risk of 0.05 and a power of 0.80. The non-inferiority margin has been set to 0.5 percentage units as there is consensus that a <1% incidence of AMI/death within 30 days represents good safety for a diagnostic strategy in chest pain patients.

Based on a total of 13100 annual chest pain patients at the three EDs and a 25% exclusion rate, a study period of 10 months will give enrollment of about 8200 patients. If 55% are discharged from the ED, about 4500 patients will be discharged both before and after implementation (i.e. a total of about 9000).

With this sample size, and an estimated median ED length of stay (LOS) in discharged patients in the control group of 240 minutes, it will be possible to detect a difference in ED LOS of about 14 minutes with a power of 0.80 and alpha of 0.05. This sample size will thereby provide adequate power to detect a clinically significant difference in ED LOS for the co-primary outcome.

• Study Type: Observational
• Enrollment (Actual): 16000

Contacts and Locations

Study Locations

• Sweden
  • Helsingborg, Sweden
    • Helsingborg General Hospital
  • Kristianstad, Sweden
    • Kristanstad Central Hospital
  • Lund, Sweden
    • Skåne University Hospital
  • Malmö, Sweden
    • Skåne University Hospital
  • Ystad, Sweden
    • Ystad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All ED patients with a primary complaint of chest pain will be screened for eligibility

Description

Inclusion Criteria:

• ED presentation with a primary complaint of non-traumatic chest pain
• Age ≥18 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: 0h/1h hs-cTnT protocol; Implementation of a 0h/1h hs-cTnT protocol in routine care
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of ED patients discharged	Comparison of the proportion of patients discharged from the ED during the intervention period versus the control period	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	Proportion of patients fulfilling 0h/1h hs-cTnT criteria (0h hs-cTnT <5 ng/L or a 0h hs-cTnT <12 ng/L with a 1h increase <3 ng/L) who have undergone objective testing (exercise stress test, myocardial perfusion imaging, CT coronary angiography, coronary angiography) within 30 days during the intervention period.	30 days from ED presentation
Non-ACS coronary care unit admissions	Comparison of the proportion of patients without acute coronary syndrome (ACS) admitted to the coronary care unit during the intervention period versus the control period.	Throughout index hospital visit, on average 2 days after ED presentation
Inappropriate coronary angiographies	Comparison of the proportion of patients who undergo inappropriate coronary angiographies during the intervention period versus the control period	Throughout index hospital visit, on average 2 days after ED presentation
Total hospital length of stay	Comparison of total hospital length of stay during the intervention period versus the control period.	Through discharge from the index hospital visit, on average 2 days after ED presentation
ED revisits	Comparison of the proportion of patients with 30-day ED revisits during the intervention period versus the control period.	30 days from ED presentation
New admissions	Comparison of the proportion of discharged patients with admissions to inpatient care within 30 days during the intervention period versus the control period.	30 days from ED presentation
Health care costs	Comparison of health care costs within 30 days during the intervention period versus the control period. These data will be presented in a separate sub-study.	30 days from ED presentation

Collaborators and Investigators

• Sponsor: Ulf Ekelund
• Collaborators: Lund University; Region Skane
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Angina Pectoris; Myocardial Infarction; Infarction; Chest Pain; Acute Coronary Syndrome; Angina, Unstable
• Other Study ID Numbers: ESC-TROP20172018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No