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)

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05764655

Acronym

POCT

Enrollment

350

Registered

2023-03-10

Start date

2022-05-06

Completion date

2023-07-31

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Myocardial Ischemia

Keywords

chest pain, Myocardial Ischemia, POCT, Troponin

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactMaria Luisa Biondi, MD, PhD

marialuisa.biondi@cardiologicomonzino.it02.58002292

Backup ContactEmilio Assanelli, MD

Emilio.Assanelli@cardiologicomonzino.it02.58002550

Outcome results