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

NCT05752188 | Completed

• 1 other identifier: 3477
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Chest Pain; Acute Coronary Syndrome

Keywords

Troponin; sST2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compare sST2 prognostic value with troponins

  24 months

• Create a multiparametric algorithm/score

  36 months

Interventions

Multimarker approach in acute coronary syndrome OTHER

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Silvia Baroni

Roma, 00168, Italy

Location

Related 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.

  PMID: 28189578 BACKGROUND

• 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.

  PMID: 30571511 BACKGROUND

• 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.

  PMID: 26320110 BACKGROUND

• 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.

  PMID: 22892889 BACKGROUND

• 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.

  PMID: 25670638 BACKGROUND

• 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.

  PMID: 18378613 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

residual serum

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Confirmed researcher - Adjunct Professor-M.D.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: July 3, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 24, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

IT (1)