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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT05354804
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Status Verified: 2023-08
• Primary Completion: 2024-03-26
• Study Completion: 2024-03-26
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1496

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of stay in the Emergency Department (ED)	Up to 24 hours	Difference in length of stay in the ED will be compared between the two arms

Secondary Outcome Measures

Name	Time	Method
Total patient episode costs	Up to 3 months	Total patient episode costs will be calculated and compared between the two arms
Total length of stay	Up to 3 months	Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms
Composite of myocardial infarction and death	1 year	Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Composite of myocardial infarction, death and revascularization	1 year	Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Symptom burden	30 days	Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms
Patients quality of life according to RAND-12	30 days	Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.
12 months costs	12 months	Costs related to all hospital contacts during 12 months follow-up
Patient satisfaction	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
Discharge rate at 3 hours	3 hours	Percentages of patients who are discharged within 3 hours will be compared between the two arms
Discharge rate at 6 hours	6 hours	Percentages of patients who are discharged within 6 hours will be compared between the two arms

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway