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)

Sponsor

Centro Cardiologico Monzino (Other)

Overall Status

Recruiting

CT.gov ID

NCT05764655

Collaborator

(none)

350

Enrollment

Location

13.8

Anticipated Duration (Months)

25.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain Myocardial Ischemia

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 Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 6, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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