Cardiac Biomarkers and Analytical Methods

NCT05781724 | Completed

• 1 other identifier: 2216
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

In the western world the prevalence of myocardial infarction is estimated at around 1-2% of the population; increases progressively with age, reaching a percentage of 10% after the 75 years. It is therefore considered the first cause of hospitalization and mortality in Western countries, as well as expenditure for the health system. It is therefore very important to have cardiac biomarkers that allow to confirm the diagnostic suspicion of coronary heart disease and/or heart failure, carry out prognostic evaluations and stratify patients as precisely as possible in relation to their actual risk. Currently as biomarkers of heart failure, natriuretic peptides (BNP and NT-proBNP) are widely used in clinical practice but, considering the complexity of heart failure and its clinical and pathophysiological heterogeneity, it is reasonable to think that a single biomarker is not sufficient . For these reasons, there is increasing interest in the scientific community in the search for new biomarkers useful for early diagnosis, for correct prognostic stratification and for evaluating the response to therapy.

Conditions

Cardiovascular Diseases; Myocardial Injury

Keywords

Troponin; sST2; NT-ProBNP; Laboratory assay

Outcome Measures

Primary Outcomes (2)

• Evaluate current and new laboratory methods and assays

  The analytical performance of the assay will be evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP15-A3 guidelines with the aim to highlight the differences respect to the methods currently used in laboratory and optimize the diagnostic accuracy and precison of the available tests. Comparison between different methods with different analytical sensitivity for the same cardiac biomarker (eg Troponin ultra- Troponin Singulex- Troponin Hs).

  24 months

• Evaluate new cardiac biomarkers

  Evaluate new cardiac biomarkers (eg sST2) to implement in the panel of available assays, in response to clinician requests, international guidelines and the emerging potential of new biochemical tests. Evaluate the medium-long term (1 year) predictive value of the new biomarker in the heart patients attending at the Emergency Department for non-STEMI Acute Chest Pain.

  24 months

Secondary Outcomes (1)

• Create a multiparametric algorithm/score

  36 months

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

500 samples, of residual serum, from patients hospitalized and/or referred to the DEA of our Polyclinic, for which troponin and/or NT-proBNP tests have been requested routinely or urgently by clinicians, will be included in the study.

You may qualify if:

• Age ≥ 18 years;
• Patients arriving in the emergency room with chest pain of presumable cardiac origin and uncertain etiological diagnosis
• Routine request for cardiac Troponin and NT-ProBNP

You may not qualify if:

• Age \<18 years;
• No requirement for cardiac Troponin and NT-ProBNP

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Silvia Baroni

Roma, 00168, Italy

Location

Related Publications (7)

• Apple FS, Collinson PO; IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem. 2012 Jan;58(1):54-61. doi: 10.1373/clinchem.2011.165795. Epub 2011 Sep 30.

  PMID: 21965555 BACKGROUND

• Bonaca MP, Ruff CT, Kosowsky J, Conrad MJ, Murphy SA, Sabatine MS, Jarolim P, Morrow DA. Evaluation of the diagnostic performance of current and next-generation assays for cardiac troponin I in the BWH-TIMI ED Chest Pain Study. Eur Heart J Acute Cardiovasc Care. 2013 Sep;2(3):195-202. doi: 10.1177/2048872613486249.

  PMID: 24222830 BACKGROUND

• Januzzi JL, Mebazaa A, Di Somma S. ST2 and prognosis in acutely decompensated heart failure: the International ST2 Consensus Panel. Am J Cardiol. 2015 Apr 2;115(7 Suppl):26B-31B. doi: 10.1016/j.amjcard.2015.01.037. Epub 2015 Jan 23.

  PMID: 25665762 BACKGROUND

• Samaha E, Avila A, Helwani MA, Ben Abdallah A, Jaffe AS, Scott MG, Nagele P. High-Sensitivity Cardiac Troponin After Cardiac Stress Test: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 Mar 19;8(6):e008626. doi: 10.1161/JAHA.118.008626.

  PMID: 30871395 BACKGROUND

• Neumann JT, Havulinna AS, Zeller T, Appelbaum S, Kunnas T, Nikkari S, Jousilahti P, Blankenberg S, Sydow K, Salomaa V. Comparison of three troponins as predictors of future cardiovascular events--prospective results from the FINRISK and BiomaCaRE studies. PLoS One. 2014 Mar 4;9(3):e90063. doi: 10.1371/journal.pone.0090063. eCollection 2014.

  PMID: 24594734 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

  PMID: 23747642 BACKGROUND

• Sarlo F, De Luca C, Moretti G, Urbani A, Baroni S. Analytical performance evaluation of the new sST2 turbidimetric assay implemented in laboratory automation systems. Clin Chem Lab Med. 2021 Oct 18;60(2):e54-e56. doi: 10.1515/cclm-2021-0851. Print 2022 Jan 27. No abstract available.

  PMID: 34655512 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

residual serum

MeSH Terms

Conditions

Cardiovascular 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

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 23, 2023
• Study Start: February 10, 2020
• Primary Completion: March 8, 2021
• Study Completion: August 31, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

IT (1)