Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06295978 |
| Other study ID # |
4896 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Andrea Piccioni, Dr. |
| Phone |
0630153161 |
| Email |
andrea.piccioni[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Chest pain is one of the most common causes of access in the Emergency Room, and it can be a
clinical manifestation of a broad spectrum of diseases including those 'time dependent'
conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial
infarction (AMI) is a daily challenge in the emergency department (ED), especially when
classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician
has the extremely delicate task of managing patients with chest pain and being able to frame
them correctly; therefore, he needs to make differential diagnosis since chest pain can be
caused by non-cardiac vascular events but also extra-cardiovascular events, such as
pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the
importance of inflammatory processes and endothelial damage in cardiovascular disease has
been highlighted, and consequently the focus has been on new markers, in a "multimarker"
approach in which the strengths of each are combined together to provide an optimal solution
to a clinical problem.
The data suggest how a future integration of these biomarkers in the routine approach to the
patient with acute chest pain in the ED might allow a better patient stratification and
proper management, allowing the clinician to make an early safe discharge or a timely
admission for those who deserve in-depth diagnostic-therapeutic investigation.
Description:
BACKGROUND: Chest pain is one of the most common causes of access in the Emergency Room, and
it can be a clinical manifestation of a broad spectrum of diseases including those 'time
dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute
myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially
when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED
physician has the extremely delicate task of managing patients with chest pain and being able
to frame them correctly; therefore, he needs to make differential diagnosis since chest pain
can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as
pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the
importance of inflammatory processes and endothelial damage in cardiovascular disease has
been highlighted, and consequently the focus has been on new markers, in a "multimarker"
approach in which the strengths of each are combined together to provide an optimal solution
to a clinical problem.
The role of the biomarker sST2 has been widely explored in heart failure, so much so that it
was included in the AHA guidelines in 2013 and 2017. Recently, several studies are also
proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary
Syndrome and ischaemic heart disease, in association with other biomarkers even proposing a
possible therapeutic differentiation.
Furthermore, current studies have explored the role of the suPAR biomarker in cardiovascular
disease. Indeed, its serum levels, closely correlated with immune and inflammatory
activation, reveal it as a promising prognostic indicator. Although its non-cardiac-specific
nature limits its diagnostic value for heart disease, its added value in identifying patients
at risk of adverse cardiovascular events, morbidity and mortality when used in a multi-marker
approach has been highlighted.
The combined use of sST2 and suPAR with high-sensitivity troponins, as opposed to
contemporary troponins, exploring complementary aspects of myocardial damage, could be a
promising strategy to identify those patients who, although with early rule-out after
evaluation in the emergency room, present a higher risk of occurrence of distant
cardiovascular events, thus deserving to be subjected to a customised diagnostic-instrumental
procedure.
