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

Acute Coronary Syndrome Clinical Trial

— WESTCOR-POC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354804
• Other study ID #: 285544
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: August 2023
• Source: Haukeland University Hospital
• Contact: Kristin M Aakre, MD/PhD
• Phone: +4755974387
• Email: kristin.moberg.aakre[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2030
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Diagnostic Test:
• Troponin I (Siemens VTli) 0/1 hour algorithm
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
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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of myocardial infarction, death and revascularization	Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.	30 days
Primary	Length of stay in the Emergency Department (ED)	Difference in length of stay in the ED will be compared between the two arms	Up to 24 hours
Primary	Patients quality of life according to RAND-12	Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.	30 days
Primary	Symptom burden	Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms	30 days
Primary	Patient satisfaction	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	30 days
Primary	Total patient episode costs	Total patient episode costs will be calculated and compared between the two arms	Up to 3 months
Secondary	Composite of myocardial infarction, death and revascularization	Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms	1 year
Secondary	Discharge rate at 3 hours	Percentages of patients who are discharged within 3 hours will be compared between the two arms	3 hours
Secondary	Discharge rate at 6 hours	Percentages of patients who are discharged within 6 hours will be compared between the two arms	6 hours
Secondary	Total length of stay	Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms	Up to 3 months
Secondary	12 months costs	Costs related to all hospital contacts during 12 months follow-up	12 months