Chest PainPOCTNCT05764655
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)
An observational study of Chest Pain and Myocardial Ischemia, run by Centro Cardiologico Monzino at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Myocardial Ischemia
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2022to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
- Sign of Informed Consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, 20138
Maria Luisa Biondi, MD, PhD, 02.58002292, marialuisa.biondi@cardiologicomonzino.it
Emilio Assanelli, MD, 02.58002550, Emilio.Assanelli@cardiologicomonzino.it
About this study
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)
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.
Read the detailed 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
- Conditions
- Chest Pain, Myocardial Ischemia
- Keywords
- chest pain, Myocardial Ischemia, POCT, Troponin
- Medical subject headings
- Chest Pain, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start6 May 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Biondi, MD, PhD, Principal investigator, IRCCS Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764655
- Sponsor's protocol ID
- CCM 1720
- Acronym
- POCT
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05764655
- Acronym / sponsor ID
- POCT / CCM 1720
- Conditions
- Chest Pain, Myocardial Ischemia
- Keywords
- chest pain, Myocardial Ischemia, POCT, Troponin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
- Sign of Informed Consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system
Time frame: through study completion, an average of 1 year
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
1 secondary outcome
The impact of the POCT system on the reduction of decision-making time
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luisa Biondi, MD, PhD principal investigator
IRCCS Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Myocardial Ischemia, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Luisa Biondi, MD, PhD (02.58002292, marialuisa.biondi@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.