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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05764655
Other study ID # CCM 1720
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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