Clinical trial NCT03421873: Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol
Official title: Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Region Skane
name: Lund University
First posted: 2018-02-05
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All ED patients with a primary complaint of chest pain will be screened for eligibility

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: AMI and all-cause death
timeFrame: 30 days from ED presentation
measure: ED length of stay
timeFrame: Through discharge from the ED, on average 5 hours after ED presentation
Secondary outcomes:
measure: Proportion of ED patients discharged
timeFrame: Through discharge from the ED, on average 5 hours after ED presentation
measure: Proportion of patients fulfilling 0h/1h hs-cTnT criteria who have undergone objective testing
timeFrame: 30 days from ED presentation
measure: Non-ACS coronary care unit admissions
timeFrame: Throughout index hospital visit, on average 2 days after ED presentation
measure: Inappropriate coronary angiographies
timeFrame: Throughout index hospital visit, on average 2 days after ED presentation
measure: Total hospital length of stay
timeFrame: Through discharge from the index hospital visit, on average 2 days after ED presentation
measure: ED revisits
timeFrame: 30 days from ED presentation
measure: New admissions
timeFrame: 30 days from ED presentation
measure: Health care costs
timeFrame: 30 days from ED presentation
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg General Hospital
city: Kristianstad
country: Sweden
facility: Kristanstad Central Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Ystad
country: Sweden
facility: Ystad Hospital
Study officials:
affiliation: Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Department of Cardiology, Lund, Sweden
name: Arash Mokhtari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Lund, Sweden
name: Ulf Ekelund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: