Defining High-Sensitivity Cardiac Troponin Concentrations in the Community

McKie, Paul M.; Heublein, Denise M.; Scott, Christopher G.; Gantzer, Mary Lou; Mehta, Ramila A.; Rodeheffer, Richard J.; Redfield, Margaret M.; Burnett, John C.; Jaffe, Allan S.

doi:10.1373/clinchem.2012.198614

Cited by 125 publications

(81 citation statements)

References 40 publications

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“…The total number of cardiomyocytes renewed per day might strictly depend on myocardial mass that, in healthy men, is usually greater than in healthy women. Few available experimental data indicate that circulating cTn levels are strictly related to both ventricular mass and gender in large populations of healthy subjects [103][104][105][106]. A recent study on 4139 subjects (2099 M and 2040 F, age range 35-74 years) found that several variables, estimated by echocardiography and reflecting cardiovascular phenotypes (including left ventricular mass), were significantly correlated with cTnI concentrations in the general population, and that their distribution differed according to gender and age [105] (Table 3).…”

Section: Mechanisms Of Troponin Release In Cardiac Patients and Healtmentioning

confidence: 99%

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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According to recent international guidelines, including the 2012 Third Universal Definiton of Myocardial Infarction by the Joint ESC/ACCF/AHA/WHF Task Force, an increase in cardiac troponin (cTn) levels over the 99th percentile upper reference limit (99th URL) should be considered clinically relevant, this cut-off being measured with an imprecision ≤10 CV%. In theory 99th URL values strongly depend not only on demographic and physiological variables (i.e. criteria for considering the reference population "healthy"), but also on the analytical performance of cTn methods and mathematical algorithms used for the calculation. The aim of the present article was therefore to review the methodological and pathophysiological factors affecting the evaluation and calculation of the 99th URL for cTn assay. The critical analysis made showed that no uniform procedure is followed, and nor have experts or regulatory bodies provided uniform guidelines for researchers or cTn assays manufacturers as an aid in "their quest to define normality". In particular, little attention has been paid to the way in which a healthy reference population is to be selected, or the criteria for calculating the 99th URL value for cTn assays, thus highlighting the need for international recommendations not only for demographic and physiological variables criteria for defining a healthy reference population, but also for calculating mathematical algorithms for establishing/ calculating clinical decision values. An expert consensus group, comprising laboratory and clinical scientists, biomedical statisticians, industrial and regulatory representatives, should be responsible for drawing up these guidelines.

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Section: Mechanisms Of Troponin Release In Cardiac Patients and Healtmentioning

confidence: 99%

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

show abstract

“…However, the real-world pro-cess leading to the selection of "normal" subjects across different studies is highly variable, ranging from a failure to supply a detailed definition of how normal subjects were selected (10 -16 ), to primarily using health questionnaires or reviewing baseline clinical characteristics (17)(18)(19)(20)(21)(22)(23)(24), to more selective screening methods using surrogate blood biomarkers, electrocardiography, imaging, and/or physical examination in addition to assessment of known baseline clinical variables (25)(26)(27)(28)(29)(30)(31)(32)(33)(34). Several studies have relied exclusively on questionnaires to define reference individuals.…”

Section: Defining Normalitymentioning

confidence: 99%

“…Most importantly, 99th percentiles were calculated as absolute, single, upper 99th percentile values. In the second study, McKie et al (34 ), using the Siemens Dimension Vista assay, defined hscTnI reference values in both community-based and healthy reference cohorts. Participants underwent clinical assessment and echocardiographic imaging evaluation, as well as surrogate biomarker screening.…”

Section: Defining Normalitymentioning

confidence: 99%

“…Various imaging methods have been applied, including stress echocardiography (25,28 ) and transthoracic echocardiograms to assess left ventricular ejection fraction (LVEF) and mass (29,(31)(32)34 ). For example, Tate et al excluded 3 out of 111 individuals who had cardiovascular abnormalities with stress echocardiography (25 ).…”

Section: Defining Normalitymentioning

confidence: 99%

“…Several studies have shown differences in 99th percentiles among men and women, especially for hs cardiac troponin assays with the ability to measure cardiac troponin concentrations above the limit of detection (LoD) of the assay in Ͼ50% of normal study participants (Table 2). For hscardiac troponin assays, sex-specific 99th percentiles will need to be determined and reported for clinical use (2,24,34,38 ).…”

Section: Sex and Agementioning

confidence: 99%

See 2 more Smart Citations

The Global Need to Define Normality: The 99th Percentile Value of Cardiac Troponin

2014

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BACKGROUND:How to select a presumably normal population for the establishment of 99th percentile cutoffs for cardiac troponin assays has not been adequately addressed. Lack of attention to this question can result in misleading medical decision cutoffs.CONTENT: From our review of the peer-reviewed literature, including international recommendations, no uniform procedure is followed and no uniform guideline has been published by experts or regulatory agencies to guide researchers or manufacturers of cardiac troponin assays in their quest to define the health or "normality" of a reference population that is used to establish an accurate 99th percentile value. As we progress globally into the era of high-sensitivity cardiac troponin assays, we propose several suggested approaches to define presumably normal individuals by use of clinical and biomarker surrogates.

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State of the Art: Newer biomarkers in heart failure

Boer

Daniels

Maisel

et al. 2015

European J of Heart Fail

166

127

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Since natriuretic peptides were successfully integrated into the clinical practice of heart failure (HF), the possibility of using new biomarkers to advance the management of affected patients has been explored. While a huge number of candidate HF biomarkers have been described recently, very few have made the difficult translation from initial promise to clinical application. These markers mirror the complex pathophysiology of heart failure at various levels: cell loss (troponin), fibrosis (ST2 and galectin‐3), infection (procalcitonin), and renal disease (several renal markers). In this review, we examine the best emerging candidates for clinical assessment and management of patients with HF.

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Defining High-Sensitivity Cardiac Troponin Concentrations in the Community

Cited by 125 publications

References 40 publications

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

The Global Need to Define Normality: The 99th Percentile Value of Cardiac Troponin

State of the Art: Newer biomarkers in heart failure

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