Prognostic Value of Cardiovascular Risk of sST2 and Troponin I-hs in Patients With Acute Chest Pain

Active, not recruiting

• Conditions: Acute Chest Pain; Acute Coronary Syndrome

• Registration Number: NCT05752188
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The role of the sST2 biomarker 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 proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischemic heart disease, in association with other biomarkers even proposing a possible therapeutic differentiation. The combined use of sST2 with high-sensitivity troponins could be a promising strategy to identify those patients who, despite having early rule-out after evaluation at the Emergency Department, have a higher risk of onset of cardiovascular events in the medium-long term.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-03
• Primary Completion: 2022-09-08
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 years;
• Chest pain of presumable cardiac origin and uncertain etiological diagnosis
• ECG not diagnostic for ischemia
• troponin values within normal ranges

Exclusion Criteria

• STEMI myocardial infarction
• 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 sST2 elevations unrelated to cardiac causes, particularly acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, malignancy, moderate to severe pulmonary fibrosis, chronic liver disease; autoimmune disorders)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate sST2 predictive value's	24 months	Evaluate the medium-long term (1 year) predictive value of the sST2 biomarker in the heart patients attending at the Emergency Department for non-STEMI Acute Chest Pain.

Secondary Outcome Measures

Name	Time	Method
Create a multiparametric algorithm/score	36 months	Integrate the sST2 values in a multiparametric algorithm/score for the differential diagnosis and risk stratification in medium/long-term complications.
Compare sST2 prognostic value with troponins	24 months	Compare the prognostic value of the new biomarker with highly sensitive troponins, for which there is already evidence in the literature

Trial Locations

Locations (1)

Silvia Baroni; 🇮🇹 Roma, Italy