Evidence map›Paper›PMID 30274965›Full record

ArticleJMIR research protocols2018

Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY HEART Study).

Valentin Walker, Anne Crijns, Johannes Langendijk, Daan Spoor, Rozemarijn Vliegenthart, Stephanie E Combs, Michael Mayinger, Arantxa Eraso, Ferran Guedea, Manuela Fiuza and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03297346 (Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.4field-weighted citation impact, top 10% 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.

NCT03297346 nacompletednot on this map

Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer (EARLY HEART Study) in the Frame of the Implications of MEDIcal Low Dose RADiation Exposure (MEDIRAD) European Project

TypeinterventionalSponsorFrench Nuclear Safety and Radiation Protection Authority (ASNR)Ran2017 to 2021Enrolled250ConditionsBreast Cancer FemaleArmsCardiac imaging and circulating biomarkers
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Cardiac substructure delineation in radiation therapy - A state-of-the-art review.Journal of medical imaging and radiation oncology · 2024
    Review
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  14. The cancer patient and cardiology.European journal of heart failure · 2020
    Review
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  16. Observational
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

17 authors at 9 institutions in 5 countries.

Valentin WalkerPôle Santé-Environnement (PSE-SANTE), Service de recherche sur les effets biologiques et sanitaires des rayonnements ionisants (SESANE), Laboratoire d'épidémiologie des rayonnements ionisants (LEPID), Institut de Radioprotection et de Sûreté Nucléaire (IRSN), Fontenay-aux-Roses, France.ORCID http://orcid.org/0000-0002-1314-6178
Anne CrijnsDepartment of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID http://orcid.org/0000-0002-3157-0626
Johannes LangendijkDepartment of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID http://orcid.org/0000-0003-1083-372X
Daan SpoorDepartment of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID http://orcid.org/0000-0001-6246-8387
Rozemarijn VliegenthartCenter for Medical Imaging, Department of Radiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID http://orcid.org/0000-0002-7262-3376
Stephanie E CombsDepartment of Radiation Oncology, Technische Universität München (TUM), München, Germany.ORCID http://orcid.org/0000-0002-6934-2864
Michael MayingerDepartment of Radiation Oncology, Technische Universität München (TUM), München, Germany.ORCID http://orcid.org/0000-0003-4433-2552
Arantxa ErasoDepartment of Radiation Oncology, Institut Català d'Oncologia, Girona, Spain.ORCID http://orcid.org/0000-0002-5378-7834
Ferran GuedeaDepartment of Radiation Oncology, Institut Català d'Oncologia, L'Hospitalet del Llobregat, Spain.ORCID http://orcid.org/0000-0001-8798-8696
Manuela FiuzaDepartment of Cardiology, Centro Cardiovascular da Universidade de Lisboa, Lisbon, Portugal.ORCID http://orcid.org/0000-0002-7742-6195
Susana ConstantinoLaboratory of Angiogenesis, Centro Cardiovascular da Universidade de Lisboa, Lisbon, Portugal.ORCID http://orcid.org/0000-0002-5711-1292
Radia TamaratPôle Santé-Environnement (PSE-SANTE), Institut de Radioprotection et de Sûreté Nucléaire (IRSN), Fontenay-aux-Roses, France.ORCID http://orcid.org/0000-0002-7109-2593
Dominique LaurierPôle Santé-Environnement (PSE-SANTE), Service de recherche sur les effets biologiques et sanitaires des rayonnements ionisants (SESANE), Institut de Radioprotection et de Sûreté Nucléaire (IRSN), Fontenay-aux-Roses, France.ORCID http://orcid.org/0000-0003-1432-4738
Jean FerrièresDepartment of Cardiology B and Epidemiology, University Hospital, Toulouse, France.ORCID http://orcid.org/0000-0001-6144-1297
Elie MousseauxDepartment of Radiology, Hôpital Européen Georges Pompidou, Paris Descartes University, Paris, France.ORCID http://orcid.org/0000-0002-8076-1445
Elisabeth CardisInstitute for Global Health (ISGlobal), Radiation Programme, Barcelona Biomedical Research Park (PRBB), Barcelona, Spain.ORCID http://orcid.org/0000-0003-0999-6839
Sophie JacobPôle Santé-Environnement (PSE-SANTE), Service de recherche sur les effets biologiques et sanitaires des rayonnements ionisants (SESANE), Laboratoire d'épidémiologie des rayonnements ionisants (LEPID), Institut de Radioprotection et de Sûreté Nucléaire (IRSN), Fontenay-aux-Roses, France.ORCID http://orcid.org/0000-0003-1729-305X
Institut de Radioprotection et de Sûreté Nucléaire · FRUniversity Medical Center Groningen · NLInstitut Català d'Oncologia · ESUniversity of Lisbon · PTHelmholtz Zentrum München · DEInserm · FRTechnical University of Munich · DEUniversitat Pompeu Fabra · ESUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBreast cancer is the most common cancer among women, and radiotherapy plays a major role in its treatment. However, breast cancer radiotherapy can lead to incidental irradiation of the heart, resulting in an increased risk for a variety of heart diseases arising many years after radiotherapy. Therefore, identifying breast cancer patients at the highest risk for radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy aging. There is still a need for precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence over time that could finally lead to cardiac complications.

objectiveThe MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising within first 2 years of breast cancer radiotherapy and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on three-dimensional dosimetry.

methodsThe EARLY HEART study is a multicenter, prospective cohort study in which 250 women treated for breast cancer and followed for 2 years after radiotherapy will be included. Women treated with radiotherapy without chemotherapy for a unilateral breast cancer and aged 40-75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on two-dimensional speckle-tracking echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging, and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose will be evaluated globally for the heart and different substructures. Furthermore, the dose-response relationship will allow modeling the radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers to develop prediction models.

resultsThis study details the protocol of the MEDIRAD EARLY HEART study and presents the main limits and advantages of this international project. The inclusion of patients began in 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021.

conclusionsThe MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patient care and quality of life.

trial registrationClinicalTrials.gov NCT03297346; https://clinicaltrials.gov/ct2/show/NCT03297346 (Archived by WebCite at http://www.webcitation.org/72KS7MIUU). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9906.

Indexed as

biomarkersbreast cancercardiac diagnostic imagingcardiotoxicityradiation dosimetryradiotherapy

Identifiers

PMID30274965
PMCPMC6242210
OpenAlexW2801292247

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Registered trials

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.