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)

Myocardial Ischemia Clinical Trial

— POCT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764655
• Other study ID #: CCM 1720
• Status: Recruiting
• Start date: May 6, 2022
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: Centro Cardiologico Monzino
• Contact: Maria Luisa Biondi, MD, PhD
• Phone: 02.58002292
• Email: marialuisa.biondi[@]cardiologicomonzino.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Emergencies
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	IRCCS Centro Cardiologico Monzino	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system	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	through study completion, an average of 1 year
Secondary	The impact of the POCT system on the reduction of decision-making time	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	through study completion, an average of 1 year