Evidence map›Paper›PMID 34355781›Full record

ArticleCardiology journal2023

Elevated serum transaminases in patients with acute coronary syndromes: Do we need a revision of exclusion criteria for clinical trials?

Małgorzata Jasiewicz, Michał Siedlaczek, Michał Kasprzak, Diana A Gorog, Bernd Jilma, Jolanta Siller-Matula, Karolina Obońska, Ryszard Dobosiewicz, Krzysztof Pstrągowski, Jacek Kubica

Open access · goldAbstract read
In one paragraph

Article in Cardiology journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 3 countries.

Małgorzata JasiewiczDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland. jasiewiczm@gmail.com.ORCID 0000-0003-0975-2586
Michał SiedlaczekDepartment of Health Promotion, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland.ORCID 0000-0002-3825-4351
Michał KasprzakDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland.
Diana A GorogDepartment of Cardiology, Lister Hospital, East and North Hertfordshire National Health Service Trust, Stevenage, United Kingdom.
Bernd JilmaSection of Immunology and Hematology, Medical University of Vienna, Austria.
Jolanta Siller-MatulaDepartment of Cardiology, Medical University of Vienna, Austria.
Karolina ObońskaDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland.
Ryszard DobosiewiczDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland.
Krzysztof PstrągowskiDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland.
Jacek KubicaDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Poland.ORCID 0000-0001-8250-754X
Nicolaus Copernicus University · PLCollegium Medicum in Bydgoszcz · PLMedical University of Vienna · ATEast and North Hertfordshire NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElevations of hepatic transaminase (serum alanine transaminase [ALT] and serum aspartate aminotransferase [AST]) levels in patients with acute coronary syndrome (ACS), although transient, may result in exclusions from clinical efficacy trials due to suspected liver disease. The aim of this study was to evaluate the concentrations of serum transaminases in ACS and relate these to currently accepted AST/ALT exclusion criteria from clinical trials.

methodsOne hundred consecutive patients with ACS were prospectively examined. Blood samples for AST, ALT, total bilirubin and troponin I concentration were obtained at the time of admission and after 6, 12 and 24 hours.

resultsEighty percent of patients had elevated AST, and 47% ALT; 43% of patients characterized AST concentration > 3 × upper limit of normal (ULN) in at least one measurement, while 8% of patients presented ALT concentration > 3 × ULN. AST presented higher concentrations when compared to ALT, resulting in a high De-Ritis ratio at every time point. No significant or high correlations were found between the concentrations of serum transaminases, De-Ritis ratio and troponin I. Two different cut-off values of troponin I were adopted to define the amount of infarcted myocardium that distinguished 28-31% of individuals with "large infarction". Among these patients, approximately 93% presented AST concentrations > 3 × ULN.

conclusionsHepatic transaminases are often elevated in ACS, with the majority of patients with more extensive myocardial injury presenting high concentrations of AST. In the setting of ACS, current transaminase thresholds for liver dysfunction used in clinical trials may lead to excessive and inadequate exclusions of patients with larger infarcts from such trials.

Indexed as

Acute Coronary SyndromeAlanine TransaminaseAspartate AminotransferasesHumansRetrospective StudiesTroponin IAlanine TransaminaseAspartate AminotransferasesTroponin Iacute coronary syndromeclinical trialexclusion criteriaserum alanine transaminaseserum aspartate aminotransferase

Identifiers

PMID34355781
PMCPMC10635717
OpenAlexW3192845036

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.