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

Acute Coronary Syndrome Clinical Trial

— sST2  

Official title:

Prognostic Value of Cardiovascular Risk of Soluble Suppression of Tumorigenesis-2 and High Sensitivity Troponin I in Patients With Acute Chest Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05752188
• Other study ID #: 3477
• Status: Active, not recruiting
• Start date: July 3, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Chest Pain
• Acute Coronary Syndrome
• Chest Pain

Intervention

Other:
• Multimarker approach in acute coronary syndrome
The main objective of the study is to evaluate the prognostic role of the biochemical marker sST2 in patients attending the Emergency Department of our hospital with acute chest pain with suspected acute coronary syndrome.

Locations

Country	Name	City	State
Italy	Silvia Baroni	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

Januzzi JL, Pascual-Figal D, Daniels LB. ST2 testing for chronic heart failure therapy monitoring: the International ST2 Consensus Panel. Am J Cardiol. 2015 Apr 2;115(7 Suppl):70B-5B. doi: 10.1016/j.amjcard.2015.01.044. Epub 2015 Jan 24. — View Citation

Reichlin T, Schindler C, Drexler B, Twerenbold R, Reiter M, Zellweger C, Moehring B, Ziller R, Hoeller R, Rubini Gimenez M, Haaf P, Potocki M, Wildi K, Balmelli C, Freese M, Stelzig C, Freidank H, Osswald S, Mueller C. One-hour rule-out and rule-in of acute myocardial infarction using high-sensitivity cardiac troponin T. Arch Intern Med. 2012 Sep 10;172(16):1211-8. doi: 10.1001/archinternmed.2012.3698. — View Citation

Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available. — View Citation

Sabatine MS, Morrow DA, Higgins LJ, MacGillivray C, Guo W, Bode C, Rifai N, Cannon CP, Gerszten RE, Lee RT. Complementary roles for biomarkers of biomechanical strain ST2 and N-terminal prohormone B-type natriuretic peptide in patients with ST-elevation myocardial infarction. Circulation. 2008 Apr 15;117(15):1936-44. doi: 10.1161/CIRCULATIONAHA.107.728022. Epub 2008 Mar 31. — View Citation

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available. Erratum In: Circulation. 2018 Nov 13;138(20):e652. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate sST2 predictive value's	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.	24 months
Secondary	Compare sST2 prognostic value with troponins	Compare the prognostic value of the new biomarker with highly sensitive troponins, for which there is already evidence in the literature	24 months
Secondary	Create a multiparametric algorithm/score	Integrate the sST2 values in a multiparametric algorithm/score for the differential diagnosis and risk stratification in medium/long-term complications.	36 months