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Completed

NCT Number: NCT05354804

Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays

The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5020, Norway

About this study

Ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. Patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ED) and impose a high work-load on hospitals. Since 2009, high-sensitivity cardiac troponin (hs-cTn) assays have become a crucial ED tool for differentiating between patients with and without Non-ST-elevation myocardial infarction (NSTEMI). Accordingly, the European Society of Cardiology (ESC) recommends 0-1 hour algorithms that use hs-cTn for rule-out and rule-in of NSTEMI.

Additionally, the clinical suspicion of acute coronary syndrome (ACS) or other life-threating conditions must be low.

Unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins.

The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS

Exclusion criteria

  • STEMI (ECG criteria)
  • Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling
  • Patients admitted from Nursing homes
  • Patients transferred from other hospitals (e.g. for PCI treatment)
  • Less than 2 months life expectancy from comorbid clinical conditions
  • Not possible to provide informed consent due to cognitive impairment, language problems or other reasons

Treatment and study plan

Troponin I (Siemens VTli) 0/1 hour algorithm

Diagnostic Test

Patients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI.

Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm

Diagnostic Test

Patients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI.

Primary outcomes

  1. Length of stay in the Emergency Department (ED)

    Time frame: Up to 24 hours

    Difference in length of stay in the ED will be compared between the two arms

Secondary outcomes

  1. Discharge rate at 3 hours

    Time frame: 3 hours

    Percentages of patients who are discharged within 3 hours will be compared between the two arms

  2. Discharge rate at 6 hours

    Time frame: 6 hours

    Percentages of patients who are discharged within 6 hours will be compared between the two arms

  3. Total length of stay

    Time frame: Up to 3 months

    Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms

  4. Composite of myocardial infarction and death

    Time frame: 30 days

    Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.

  5. Composite of myocardial infarction, death and revascularization

    Time frame: 30 days

    Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms

  6. Composite of myocardial infarction and death

    Time frame: 1 year

    Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.

  7. Composite of myocardial infarction, death and revascularization

    Time frame: 1 year

    Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms

  8. Total patient episode costs

    Time frame: Up to 3 months

    Total patient episode costs will be calculated and compared between the two arms

  9. 12 months costs

    Time frame: 12 months

    Costs related to all hospital contacts during 12 months follow-up

  10. Patients quality of life according to RAND-12

    Time frame: 30 days

    Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.

  11. Symptom burden

    Time frame: 30 days

    Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms

  12. Patient satisfaction

    Time frame: 30 days

    Change in patients satisfaction with the hospital admission/contact will be measured 30 days after discharge using PasOP14 questionnaire and compared between the two arms

Other outcomes

  1. Re-admission

    Time frame: 30 days

    Readmission of any cause within 30 days after inclusion

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Acronym: WESTCOR-POC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2022
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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