Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295978
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-02-15
Brief Title:
Multimarker Approach in Acute Chest Pain
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Prognostic Value of Cardiovascular Risk of sST2 suPAR and High-sensitivity Troponin I in Patients With Acute Chest Pain
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None