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)
POCT
1 other identifier
observational
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2022
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMarch 10, 2023
February 1, 2023
1.2 years
February 21, 2023
March 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The impact of the POCT system on the reduction of decision-making time
through study completion, an average of 1 year
Eligibility Criteria
Patients accessing at emergency room for acute chest pain suspected of acute myocardial ischemia, who are asked for Troponin determination in the pathway decision-making.
You may qualify if:
- Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
- Sign of Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Centro Cardiologico Monzino
Milan, 20138, Italy
Biospecimen
Troponin determination
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Luisa Biondi, MD, PhD
IRCCS Centro Cardiologico Monzino
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 10, 2023
Study Start
May 6, 2022
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
March 10, 2023
Record last verified: 2023-02