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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)

C

Centro Cardiologico Monzino

Status

Enrolling

Conditions

Myocardial Ischemia
Chest Pain

Study type

Observational

Funder types

Other

Identifiers

NCT05764655
CCM 1720

Details and patient eligibility

About

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.

Full 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

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Central trial contact

Emilio Assanelli, MD; Maria Luisa Biondi, MD, PhD

Data sourced from clinicaltrials.gov

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