Cardiac Biomarkers and Analytical Methods

March 12, 2023 updated by: Baroni Silvia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Silvia Baroni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate current and new laboratory methods and assays
Time Frame: 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).
24 months
Evaluate new cardiac biomarkers
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Create a multiparametric algorithm/score
Time Frame: 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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Actual)

March 8, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe