One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— OUT-ACS  

Official title:

Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983123
• Other study ID #: 2016/1241/REK
• Secondary ID: 2016/13308
• Status: Completed
• Start date: November 15, 2016
• Est. completion date: October 22, 2018

Study information

• Verified date: March 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the values will decide whether the patient need hospitalization or not.

Description:

Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These patients do not need a directly transfer to the hospital, but can be admitted to the Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins for a safe rule-out of acute MI. The main goal of this study is to improve the current routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for a faster rule-in/rule-out of acute MI.

All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1750
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at the outpatient clinic with suspected non-cardiac chest pain/symptoms who need further testing for a safe rule-out of an acute MI

• Written informed consent

Exclusion Criteria:

• Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)

• Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)

• Terminal kidney disease with a glomerular filtration rate (GFR) < 30

• Unable to communicate in Norwegian, Swedish, Danish or English language

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI
• Syndrome

Intervention

Procedure:
• 1-hour hs-cTnT

Locations

Country	Name	City	State
Norway	Oslo Accident and Emergency Outpatient Clinic	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm	The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.	7-10 hours
Primary	Number of patients without significant changes (rule-out) according to the 1-hour algorithm	The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.	7-10 hours
Secondary	Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm		10 hours
Secondary	Significant changes between the first and second ECG?		6 hours
Secondary	Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC	The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study	1 week
Secondary	90 days follow-up of all recruited patients	How many will have an acute MI the next 3 months?	90 days