Clinical trial · Interventional
Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications. In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac imaging and circulating biomarkers | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breast cancer patients treated with RT
- description
- Cardiac imaging and circulating biomarkers measurements to evaluate: * myocardial dysfunction and deformation (ECHO-ST) * coronary artery lesions and coronary artery calcium score (CT) * myocardium including tissue abnormalities, cardiac morphology and function (MRI) * blood-based biomarkers of cardiovascular changes (BLOOD)
- interventionNames
- Other: Cardiac imaging and circulating biomarkers
Primary outcomes (1)
- measure
- Number of patients with decreased myocardial function assessed by echocardiography
- timeFrame
- 2 years after radiotherapy (baseline measurements performed before radiotherapy)
- description
- Number of patients with an increased of at least 2.5% in the Global Longitudinal Strain (GLS) between baseline and 2 years after radiotherapy
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female unilateral breast cancer patients * Treated with primary breast conserving surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS) * Age between 40-75 years at time of start radiotherapy * World Health Organisation (WHO) performance status 0-1 * Planned for radiotherapy alone to the breast with or without the lymph node areas * Radiotherapy based on planning-CT scan using either three dimensional conformal radiation therapy (3D-CRT), Intensity-modulated radiotherapy (IMRT), or Volumetric Arc Therapy (VMAT/RapidArc) * Written Informed consent Exclusion Criteria: * Male breast cancer patients * Neoadjuvant or adjuvant chemotherapy * M1 disease (metastatic breast cancer) * Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation * Previous thoracic or mediastinal radiation * Contraindications to injection of iodinated contrast such as allergy or renal failure * Pregnancy or lactation * Atrial fibrillation detected during electrocardiogram before radiotherapy * Abnormal echocardiography before radiotherapy defined as: Left Ventricular Ejection Fraction\<50%; longitudinal strain ≤ -16%; longitudinal strain rate \<-1%, and/or abnormal wall motion * Presence of myocardial infarction detected during MRI before radiotherapy * CT or MRI results before radiotherapy requiring revascularisation
References
Publications (4)
- DERIVEDMousseaux E, Craiem D, Vliegenthart R, Jacob S, Eraso A, Constantino Rosa Santos S, Borm K, Langendijk JA, Locquet M, Ventura M, Fiuza M, Combs SE, Spoor DS, Crijns APG; MEDIRAD EARLY-HEART investigators. Cardiac Radiation Dose and Subclinical Coronary Artery Disease Progression after Breast Cancer Radiotherapy: 2-year Cardiac CT Results from the EARLY-HEART Study. Radiol Cardiothorac Imaging. 2026 Jun;8(3):e250342. doi: 10.1148/ryct.250342. PMID 42165741
- DERIVEDLamy J, Spoor DS, Langendijk JA, Vliegenthart R, Eraso A, Ventura M, Constantino Rosa Santos S, Fiuza M, Kachenoura N, Crijns APG, Mousseaux E; MEDIRAD EARLY-HEART investigators. Cardiac MRI-based Subclinical Cardiac Dysfunction during 2 Years after Breast Cancer Irradiation: The MEDIRAD EARLY-HEART Study. Radiol Cardiothorac Imaging. 2025 Apr;7(2):e240231. doi: 10.1148/ryct.240231. PMID 40178396
- DERIVEDLocquet M, Spoor D, Crijns A, van der Harst P, Eraso A, Guedea F, Fiuza M, Santos SCR, Combs S, Borm K, Mousseaux E, Gencer U, Frija G, Cardis E, Langendijk H, Jacob S. Subclinical Left Ventricular Dysfunction Detected by Speckle-Tracking Echocardiography in Breast Cancer Patients Treated With Radiation Therapy: A Six-Month Follow-Up Analysis (MEDIRAD EARLY-HEART study). Front Oncol. 2022 Jun 28;12:883679. doi: 10.3389/fonc.2022.883679. eCollection 2022. PMID 35837099
- DERIVEDWalker V, Crijns A, Langendijk J, Spoor D, Vliegenthart R, Combs SE, Mayinger M, Eraso A, Guedea F, Fiuza M, Constantino S, Tamarat R, Laurier D, Ferrieres J, Mousseaux E, Cardis E, Jacob S. Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY HEART Study). JMIR Res Protoc. 2018 Oct 1;7(10):e178. doi: 10.2196/resprot.9906. PMID 30274965