Cardiac: Is this biomarker ready for the prime time?

Abstract

Today, the increase of the blood concentration of cardiac troponins is designated as surrogate for cardiac necrosis and myocardial infarction, when an appropriate clinical and/or instrumental situation is present. As cardiac troponins refl ect myocyte death, biomarkers of reversible myocardial damage in the absence of necrosis are, however, still needed to detect the presence of damage even before the irreversible injury is induced and identify " vulnerable " patients before major events occur, permitting adequate treatment. Markers of plaque destabilization and/or markers of myocardial ischemia could be enormously valuable in the emergency department setting if shown to contribute additional independent diagnostic information. However, a new cardiac biomarker is of defi nitive clinical value only if adequate assays for its measurement are available, its predictive value is defi ned in the right clinical context, optimal cut-off and release kinetics are known, demonstration of the marker incremental value is clear, there is consistency of marker performance across different settings, and, more importantly, there are data on the effect on patient management and outcome and on cost-effectiveness. Despite the emergence of multiple candidates, suffi cient evidence for any of these has yet been demonstrated to recommend their adoption into clinical practice.

Biomarkers in Idiopathic Pulmonary Fibrosis

“…Before considering the clinical implementation of the biomarker candidate, it must be evaluated critically with respect to key analytical and clinical characteristics. Criteria to be satisfied for definitive clinical implementation of biomarker related to the test such as adequate assays for its measurement, its predictive value defined in specific clinical contexts, optimal cut-off(s), and known timing of measurement (release kinetics) [25,26].…”

Laboratory medicine in the new healthcare environment

“…However, where a new test is more sensitive than an old test, assuming specificity, harms and costs are the same, the new test will lead to the detection of additional cases of disease. In this case, randomised trials are required to assess treatment efficacy in cases detected by the new diagnostic test, unless the new test detects the same spectrum and subtype of disease as the old one [39,41]. Indeed, diagnostic accuracy is not a "true" health outcome as this type of study answers the question "Does the result of the laboratory test predict an outcome of interest (e.g.…”

“…There are examples showing that clinical investigators are often too quick in publishing data without collecting and including thorough evidence of assay performance [41]. Some years ago, soluble CD40 ligand, a platelet activation marker, was shown to predict mortality in patients with unstable angina and to be useful for guiding antiplatelet treatment [63,64].…”

Introduction

“…Baker (2005) further indicates that the "omics" revolution provides for quite a few decision-making tools. Panteghini (2010) in a recent article on cardiac biomarkers emphasizes the need for a cardiac biomarker that detects the presence of myocardial damage even before the reversible myocardial damage is induced, and thereby help identify the vulnerable patients before major events occur, permitting prior treatment. Illyin et al (2004) indicate that the field of biomarkers has application in the diagnosis, prognosis, and in monitoring disease progression.…”