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

NCT05354804 | Completed

• 1 other identifier: 285544
• Study Type: interventional
• Target: 1,496
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Discharge rate at 3 hours

  3 hours

• Discharge rate at 6 hours

  6 hours

• Total length of stay

  Up to 3 months

• Composite of myocardial infarction and death

  30 days

• Composite of myocardial infarction, death and revascularization

  30 days

Other Outcomes (1)

• Re-admission

  30 days

Study Arms (2)

Standard

PLACEBO COMPARATOR

Patients randomized to standard care will be sampled at admission and after 1 hour (and furthermore as clinically indicated). High sensitive Troponin T (cTnT) and standard laboratory tests will be measured in the central hospital laboratory using Cobas e801 from Roche Diagnostics and eligibility for rule-out will be judged in accordance with the ESC 0/1 hour rule-out algorithm for cTnT. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If NSTE-ACS is low risk based on the cTnT algorithm, HEART\< 4 and non-ischemic ECG, patients will be investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnoses. Patients will be admitted or discharged based on the clinical judgement of the attending physician.

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

POC

ACTIVE COMPARATOR

Blood samples will be obtained at admission, standard blood tests will be measured at the central laboratory whilst high sensitive troponin I at 0 and 1 hour will be analyzed using a POC instrument from Siemens Healthineers in the ED. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If the cTnI concentration at admission and the 1-hour delta is below a pre-specified concentration, the HEART- score \< 4, and the ECG is non-ischemic the patients will be allocated to the rule-out of NSTEMI group and investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnosis. Finally, patients will be admitted or discharged based on the clinical judgement of the attending physician.

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

Interventions

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.

POC

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.

Standard

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5020, Norway

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Kristin M Aakre, MD/PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 29, 2022
• Study Start: March 14, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: July 19, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)