Clinical trial NCT05752188: Prognostic Value of Cardiovascular Risk of sST2 and Troponin I-hs in Patients With Acute Chest Pain
Official title: Prognostic Value of Cardiovascular Risk of Soluble Suppression of Tumorigenesis-2 and High Sensitivity Troponin I in Patients With Acute Chest Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Chest Pain
Acute Coronary Syndrome
Keywords: Troponin
sST2
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The evaluation of the efficacy of the sST2 and cTNI HS biomarkers will be evaluated retrospectively without altering the normal diagnostic and therapeutic procedure in the recruited patients.

The results of sST2 and Troponins will then be evaluated on the basis of the clinical outcomes obtained by telephone interview with the patient carried out at 1 year.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Evaluate sST2 predictive value's
timeFrame: 24 months
Secondary outcomes:
measure: Compare sST2 prognostic value with troponins
timeFrame: 24 months
measure: Create a multiparametric algorithm/score
timeFrame: 36 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Silvia Baroni
Study officials:
References:
citation: Aimo A, Vergaro G, Ripoli A, Bayes-Genis A, Pascual Figal DA, de Boer RA, Lassus J, Mebazaa A, Gayat E, Breidthardt T, Sabti Z, Mueller C, Brunner-La Rocca HP, Tang WH, Grodin JL, Zhang Y, Bettencourt P, Maisel AS, Passino C, Januzzi JL, Emdin M. Meta-Analysis of Soluble Suppression of Tumorigenicity-2 and Prognosis in Acute Heart Failure. JACC Heart Fail. 2017 Apr;5(4):287-296. doi: 10.1016/j.jchf.2016.12.016. Epub 2017 Feb 8.
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