Comparison of Troponin Assay With New POCT Method in the Decision-making Pathway of Patient With Chest Pain Suspected of Acute Myocardial Ischemia in Emergency Room (POCT)

Recruiting

• Conditions: Myocardial Ischemia; Chest Pain

• Registration Number: NCT05764655
• Lead Sponsor: Centro Cardiologico Monzino

Brief Summary

This is a prospective observational study aiming to evaluate the diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system (by comparison with the results obtained with the Atellica diagnostic system currently in use) and to evaluate the impact of the POCT system on the reduction of decision-making time (particularly of "rule-out"), by evaluating the number of cases in which the conclusion of the decision pathway at 3 h (algorithm currently in use) could have been concluded at 1 h.

Detailed Description

Patients accessing the emergency room for chest pain suspected of acute myocardial ischemia, who are asked for Troponin determination for the decision pathway, will be asked to participate at the study. A blood draw will be performed (for determination of Troponin value, with classical method in use and with POCT method) at time:

* Zero (acess at the emergency room)

* 1 h

* 3 h

Study Timeline

• Study Start: 2022-05-06
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
• Sign of Informed Consent

Exclusion Criteria

• Diagnostic electrocardiographic picture for Acute Coronary Syndrome-STEMI (ACS-STEMI)
• Absence of symptomatology in the 12 hours prior to admission to the emergency room
• Post-traumatic chest pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system	through study completion, an average of 1 year	Evaluate the diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system by comparison with results obtained with the Atellica diagnostic system currently in use

Secondary Outcome Measures

Name	Time	Method
The impact of the POCT system on the reduction of decision-making time	through study completion, an average of 1 year	Evaluate the impact of the POCT system on the reduction of decision-making time, by evaluating the number of cases in which the end of the decision pathway at 3 h (algorithm currently in use) could have been done at 1 h

Trial Locations

Locations (1)

IRCCS Centro Cardiologico Monzino; 🇮🇹 Milan, Italy