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)

NCT ID: NCT05764655

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-06

Study Completion Date

2023-07-31

Brief Summary

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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

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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

Conditions

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Chest Pain Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Luisa Biondi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Centro Cardiologico Monzino

Locations

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IRCCS Centro Cardiologico Monzino

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maria Luisa Biondi, MD, PhD

Role: CONTACT

02.58002292

Emilio Assanelli, MD

Role: CONTACT

02.58002550

Facility Contacts

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Maria Luisa Biondi, MD, PhD

Role: primary

02.58002292

Emilio Assanelli, MD

Role: backup

02.58002550

Other Identifiers

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CCM 1720

Identifier Type: -

Identifier Source: org_study_id

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