- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06295978
Multimarker Approach in Acute Chest Pain
Prognostic Value of Cardiovascular Risk of sST2, suPAR and High-sensitivity Troponin I in Patients With Acute Chest Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andrea Piccioni, Dr.
- Phone Number: +39 0630153161
- Email: andrea.piccioni@policlinicogemelli.it
Study Contact Backup
- Name: Alessandra Bronzino, Dott.ssa
- Phone Number: +393497383972
- Email: alessandra.bronzino@policlinicogemelli.it
Study Locations
-
-
-
Roma, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
-
Contact:
- ANDREA PICCIONI, Dr.
- Phone Number: 0630153161
- Email: andrea.piccioni@policlinicogemelli.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years;
- Patients who came to the emergency department with chest pain of presumable cardiac origin and uncertain etiologic diagnosis
- ECG not diagnostic for ischemia
- cTnI ultra within limits
Exclusion Criteria:
- STEMI
- Sepsis and viral infections
- Patients with ECG abnormalities that make it uninterpretable for ischemic purposes
- Patients with previous coronary events
- History of heart failure
- Known diagnosis of cardiovascular disease, acute or chronic, including pericarditis, myocarditis
- Conditions involving increases in sST2 and suPAR unrelated to cardiac causes, especially acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, neoplasms, moderate-to-severe pulmonary fibrosis, chronic hepatopathy; autoimmune diseases)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The predictive value of markers for the risk of cardiovascular events in chest pain
Time Frame: 2 years
|
Evaluate the medium-long term (1 year) predictive value of the sST2, suPAR and IL6 biomarkers in patients attending the emergency department for acute non-STEMI chest pain
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multimarker approach to improve cardiovascular risk stratification
Time Frame: 2 years
|
A multimarker approach in combination with high-sensitivity troponin (hsTnI), improve cardiovascular risk stratification
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4896
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease Other
-
National Heart Centre SingaporeDuke-NUS Graduate Medical SchoolCompletedCardiovascular Disease OtherSingapore
-
Rigshospitalet, DenmarkHerlev HospitalNot yet recruitingChildren, Only | IVF | Cardiovascular Disease Other | ARTDenmark
-
Wayne State UniversityRecruitingHypertension | Blood Pressure | Cardiovascular Disease OtherUnited States
-
Washington University School of MedicineNational Alliance for Research on Schizophrenia and DepressionCompletedCardiovascular Disease | SchizophreniaUnited States
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Helse Nord-Trøndelag HFCompletedCardiovascular Disease | SchizophreniaNorway
-
Jamie JacksonNational Heart, Lung, and Blood Institute (NHLBI)CompletedPhysical Activity | Cardiovascular Disease OtherUnited States
-
Jamie JacksonCompletedPhysical Activity | Cardiovascular Disease OtherUnited States
-
Wollo UniversityRecruitingOther Cardiovascular Diseases of Mother, PostpartumEthiopia
-
Jamie JacksonNational Institute of Nursing Research (NINR)RecruitingHeart Defects, Congenital | Cardiovascular Disease OtherUnited States
-
Haukeland University HospitalCompletedBleeding | Surgery | Cardiovascular Disease OtherNorway
Clinical Trials on Biochemical marker assays
-
Beckman Coulter, Inc.Recruiting
-
Centre Hospitalier Universitaire VaudoisRecruitingLung Cancer | Lung Metastases | RadiotherapySwitzerland
-
University of California, San FranciscoHarvard Medical School (HMS and HSDM); National Institute of Allergy and Infectious... and other collaboratorsRecruitingTuberculosisSouth Africa, Uganda, Georgia, India, Philippines, Vietnam
-
Endomagnetics IncM.D. Anderson Cancer CenterRecruitingBreast Cancer | Axillary Lymph NodesUnited States
-
Fundación Española de Hematología y HemoterapíaRecruitingAcquired Thrombotic Thrombocytopenic PurpuraSpain, Portugal
-
Central Hospital, Nancy, FranceNot yet recruitingSARS-CoV-2 InfectionFrance
-
Tepecik Training and Research HospitalCompleted
-
Bahçeşehir UniversityCompletedInflammation | Oxidative Stress | Temporomandibular DisorderTurkey
-
Tabba Heart InstituteUnknownNew Time Clock for ST-elevation MI Based on Biochemical Myocardial Infarction Onset Time (BIT-STEMI)Coronary Artery Disease | Mi Q WavePakistan
-
Mario Negri Institute for Pharmacological ResearchTerminated