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Cardiovascular DiseasesNCT05781724

Cardiac Biomarkers and Analytical Methods

An observational study of Cardiovascular Diseases and Myocardial Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Cardiovascular Diseases, Myocardial Injury
How many people
500 participants
Where
1 siteItaly
Study dates
10 Feb 2020to 31 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Silvia Baroni

    Roma, 00168

Other trials in Italy

About this study

Official title: Cardiac Biomarkers:Comparison Between Analytical Methods

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.

Read more

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.

Read the detailed description

The study aims to evaluate the analytical performance of different kits and molecular markers commercially available (or in pre-industrial development phase) for the assays of the cardiac biomarkers: cTnI , NT-proBNP and sST2.

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

The analytical performance of the various kits and the intra- and interassay imprecision will be evaluated. Comparison of methods will be calculated by Passing-Bablok regression and graph by Bland-Altman.

Through the non-parametric Passing-Bablok model the obtained data will be compared with the various analytical methods, reporting them one in function of the other, together with the regression line.

From the regression equation, the proportional systematic error will be evaluated as angular coefficient of the straight line and the constant systematic error as an intercept of the equation

Keywords
Troponin, sST2, NT-ProBNP, Laboratory assay
Medical subject headings
Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 24 months

  2. 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.

    Measured: 24 months

Secondary outcomes (1)

  1. Create a multiparametric algorithm/score

    Integrate the new cardiac biomarkers values in a multiparametric algorithm/score for the differential diagnosis and risk stratification in medium/long-term complications.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start10 Feb 2020
  3. Primary completion8 Mar 2021
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05781724
Sponsor's protocol ID
2216
Status last verified
Sep 2024
First submitted
21 Feb 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21965555

  • 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.

    PubMed 24222830

  • 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.

    PubMed 25665762

  • 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.

    PubMed 30871395

  • 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.

    PubMed 24594734

  • 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.

    PubMed 23747642

  • 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.

    PubMed 34655512

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Myocardial Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate current and new laboratory methods and assays (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05781724, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024; AzTrials last refreshed its copy on 4 Nov 2026.

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