Clinical trial NCT05354804: Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
Official title: Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2022-04-29
Enrollment: 1496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay in the Emergency Department (ED)
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Discharge rate at 3 hours
timeFrame: 3 hours
measure: Discharge rate at 6 hours
timeFrame: 6 hours
measure: Total length of stay
timeFrame: Up to 3 months
measure: Composite of myocardial infarction and death
timeFrame: 30 days
measure: Composite of myocardial infarction, death and revascularization
timeFrame: 30 days
measure: Composite of myocardial infarction and death
timeFrame: 1 year
measure: Composite of myocardial infarction, death and revascularization
timeFrame: 1 year
measure: Total patient episode costs
timeFrame: Up to 3 months
measure: 12 months costs
timeFrame: 12 months
measure: Patients quality of life according to RAND-12
timeFrame: 30 days
measure: Symptom burden
timeFrame: 30 days
measure: Patient satisfaction
timeFrame: 30 days
Other outcomes:
measure: Re-admission
timeFrame: 30 days
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Kristin M Aakre, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: