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

September 10, 2019 updated by: Ulf Ekelund

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AMI and all-cause death
Time Frame: 30 days from ED presentation
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
Time Frame: Through discharge from the ED, on average 5 hours after ED presentation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of ED patients discharged
Time Frame: Through discharge from the ED, on average 5 hours after ED presentation
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
Time Frame: 30 days from ED presentation
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
Time Frame: Throughout index hospital visit, on average 2 days after ED presentation
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
Time Frame: Throughout index hospital visit, on average 2 days after ED presentation
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
Time Frame: Through discharge from the index hospital visit, on average 2 days after ED presentation
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
Time Frame: 30 days from ED presentation
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
Time Frame: 30 days from ED presentation
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
Time Frame: 30 days from ED presentation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ulf Ekelund

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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