Cardiac Biomarkers and Analytical Methods

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05781724

Collaborator

(none)

500

Enrollment

Location

46.7

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Myocardial Injury

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

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Cardiac Biomarkers:Comparison Between Analytical Methods

Actual Study Start Date :

Feb 10, 2020

Actual Primary Completion Date :

Mar 8, 2021

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Evaluate current and new laboratory methods and assays [24 months]
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).
Evaluate new cardiac biomarkers [24 months]
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.

Secondary Outcome Measures

Create a multiparametric algorithm/score [36 months]
Integrate the new cardiac biomarkers values in a multiparametric algorithm/score for the differential diagnosis and risk stratification in medium/long-term complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Silvia Baroni	Roma		Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Baroni Silvia, Confirmed researcher - Adjunct Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05781724

Other Study ID Numbers:

2216

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Baroni Silvia, Confirmed researcher - Adjunct Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Mar 23, 2023