Evidence map›Paper›PMID 26170152›Full record

ArticleJournal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance2015

2015 Update on Acute Adverse Reactions to Gadolinium based Contrast Agents in Cardiovascular MR. Large Multi-National and Multi-Ethnical Population Experience With 37788 Patients From the EuroCMR Registry.

O Bruder, S Schneider, G Pilz, A C van Rossum, J Schwitter, D Nothnagel, M Lombardi, S Buss, A Wagner, S Petersen and 5 more

Abstract readComparative StudyMulticenter Study
In one paragraph

Article in Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–field-weighted citation impact
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

26 citing papers in PubMed.

  1. High-throughput gadobutrol-enhanced CMR: a time and dose optimization study.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2017
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  4. A case report of gadopentetate dimeglumine-induced cardiac arrest: Resuscitation using extracorporeal membrane oxygenation.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2023
    Article
  5. Review
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  10. Journal of Cardiovascular Magnetic Resonance: 2017/2018 in review.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2019
    Review
  11. Article
  12. Article
  13. Article
  14. Updates on the Role of Imaging in Cardiac Sarcoidosis.Current treatment options in cardiovascular medicine · 2018
    Review
  15. Review of Journal of Cardiovascular Magnetic Resonance (JCMR) 2015-2016 and transition of the JCMR office to Boston.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2017
    Review
  16. Review
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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

15 authors.

O BruderDepartment of Cardiology and Angiology, Elisabeth Hospital, Essen, Germany. O.Bruder@contilia.de.
S SchneiderInstitut für Herzinfarktforschung, Department of Biometrics, Ludwigshafen, Germany. Schneider@stiftung-ihf.de.
G PilzDepartment of Cardiology, Hospital Agatharied, Hausham, Germany. Guenter.Pilz2@khagatharied.de.
A C van RossumDepartment of Cardiology, VU University Medical Centre, Amsterdam, The Netherlands. Ac.vrossum@vumc.nl.
J SchwitterCentre Hospitalier Universitaire Vaudois - CHUV University of Lausanne, Lausanne, Switzerland. Jurg.Schwitter@chuv.ch.
D NothnagelDepartment of Cardiology, Klinikum Ludwigsburg, Ludwigsburg, Germany. Detlev.Nothnagel@kliniken-lb.de.
M LombardiFondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy. lomass@ifc.cnr.it.
S BussDepartment of Cardiology, University of Heidelberg, Heidelberg, Germany. Sebastian.Buss@med.uni-heidelberg.de.
A WagnerCardiology Associates of Fairfield, Stamford, CT, USA. anja.wagner@gmail.com.
S PetersenBarts and The London NIHR Biomedical Research Unit, London Chest Hospital, London, United Kingdom. S.e.petersen@qmul.ac.uk.
S GreulichDepartment of Cardiology, Robert Bosch Medical Centre, Stuttgart, 70376, Germany. Simon.greulich@rbk.de.
C JensenDepartment of Cardiology and Angiology, Elisabeth Hospital, Essen, Germany. C.Jensen@contilia.de.
E NagelDivision of Cardiovascular Imaging, J.W. Goethe University Frankfurt, Frankfurt am Main, Germany; German Center of Cardiovascular Research, Frankfurt, Germany. eike.nagel@cardiac-imaging.org.
U SechtemDepartment of Cardiology, Robert Bosch Medical Centre, Stuttgart, 70376, Germany. Udo.sechtem@rbk.de.
H MahrholdtDepartment of Cardiology, Robert Bosch Medical Centre, Stuttgart, 70376, Germany. Heiko.Mahrholdt@rbk.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesSpecifically we aim to demonstrate that the results of our earlier safety data hold true in this much larger multi-national and multi-ethnical population.

backgroundWe sought to re-evaluate the frequency, manifestations, and severity of acute adverse reactions associated with administration of several gadolinium- based contrast agents during routine CMR on a European level.

methodsMulti-centre, multi-national, and multi-ethnical registry with consecutive enrolment of patients in 57 European centres.

resultsDuring the current observation 37,788 doses of Gadolinium based contrast agent were administered to 37,788 patients. The mean dose was 24.7 ml (range 5-80 ml), which is equivalent to 0.123 mmol/kg (range 0.01 - 0.3 mmol/kg). Forty-five acute adverse reactions due to contrast administration occurred (0.12%). Most reactions were classified as mild (43 of 45) according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (15 of 45), followed by nausea (10 of 45) and flushes (10 of 45). The event rate ranged from 0.05% (linear non-ionic agent gadodiamide) to 0.42% (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR ranging from 0.05% (risk stratification in suspected CAD) to 0.22% (viability in known CAD).

conclusionsThe current data indicate that the results of the earlier safety data hold true in this much larger multi-national and multi-ethnical population. Thus, the "off-label" use of Gadolinium based contrast in cardiovascular MR should be regarded as safe concerning the frequency, manifestation and severity of acute events.

Indexed as

Adverse Drug Reaction Reporting SystemsAcute DiseaseCardiovascular DiseasesContrast MediaDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsEuropeGadoliniumHumansMagnetic Resonance ImagingPatient SafetyRegistriesRisk AssessmentRisk FactorsSeverity of Illness IndexContrast MediaGadolinium

Identifiers

PMID26170152
PMCPMC4501068

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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.