Multimarker Approach in Acute Chest Pain

NCT06295978 | Recruiting

• 1 other identifier: 4896
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Other

Keywords

Biomarkers; Chest pain; suPAR; sST2

Outcome Measures

Primary Outcomes (1)

• The predictive value of markers for the risk of cardiovascular events in chest pain

  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 Outcomes (1)

• Multimarker approach to improve cardiovascular risk stratification

  2 years

Interventions

Biochemical marker assays DIAGNOSTIC_TEST

DOSAGE BIOMARKERS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients entering the emergency department with chest pain or other typical symptoms suspected of ACS will be included in the study if they are adults, not pregnant, and meet the predetermined inclusion criteria. Furthermore, patients who sign written informed consent to participate in the study and to the processing of personal data

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Piccioni, Dr.

CONTACT

0630153161; andrea.piccioni@policlinicogemelli.it

Alessandra Bronzino, Dott.ssa

CONTACT

+393497383972; alessandra.bronzino@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 6, 2024
• Study Start: February 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)