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

NCT02983123 | Completed

• 2 other identifiers: 2016/1241/REK2016/13308
• Study Type: observational
• Target: 1,750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Acute MI; Acute myocardial infarction cardiac troponin; High-sensitivity cardiac troponin T; 0/1-hour algorithm; Outpatient clinic; Cardiac troponin; Chest pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

• Significant changes between the first and second ECG?

  6 hours

• Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC

  1 week

• 90 days follow-up of all recruited patients

  90 days

Study Arms (1)

1 hour-troponin

1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours.

Procedure: 1-hour hs-cTnT

Interventions

1-hour hs-cTnT PROCEDURE

1 hour-troponin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Oslo Accident and Emergency Outpatient Clinic with symptoms suggestive of a benign non-cardiac chest pain, who needs further pre-hospital testing at the Observation Unit for a safe rule-out of an acute MI.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo Accident and Emergency Outpatient Clinic

Oslo, 0182, Norway

Location

Related Publications (4)

• Johannessen TR, Melessen IMB, Vallersnes OM, Manten A, Halvorsen S, Atar D, Harskamp RE. Adequately identifying low-risk chest pain in emergency primary care: evaluating the performance of preHEAR(T) based on two European cohorts. Open Heart. 2025 Jul 27;12(2):e003362. doi: 10.1136/openhrt-2025-003362.

  PMID: 40716792 DERIVED

• Johannessen TR, Halvorsen S, Atar D, Vallersnes OM. Performance of the Novel Observation Group Criteria of the European Society of Cardiology (ESC) 0/1-Hour Algorithm in a Low-Risk Population. J Am Heart Assoc. 2022 Apr 5;11(7):e024927. doi: 10.1161/JAHA.121.024927. Epub 2022 Mar 30. No abstract available.

  PMID: 35352564 DERIVED

• Johannessen TR, Atar D, Vallersnes OM, Larstorp ACK, Mdala I, Halvorsen S. Comparison of a single high-sensitivity cardiac troponin T measurement with the HEART score for rapid rule-out of acute myocardial infarction in a primary care emergency setting: a cohort study. BMJ Open. 2021 Feb 24;11(2):e046024. doi: 10.1136/bmjopen-2020-046024.

  PMID: 33627355 DERIVED

• Johannessen TR, Vallersnes OM, Halvorsen S, Larstorp ACK, Mdala I, Atar D. Pre-hospital One-Hour Troponin in a Low-Prevalence Population of Acute Coronary Syndrome: OUT-ACS study. Open Heart. 2020 Jul;7(2):e001296. doi: 10.1136/openhrt-2020-001296.

  PMID: 32719074 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dan Atar, MD, PhD

  Oslo University Hospital and University of Oslo, Norway

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology and Head of Research

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 6, 2016
• Study Start: November 15, 2016
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)