Clinical trial · Observational
Early Detection of Imaging-derived Subclinical Cardiac Injuries
Early Detection of Imaging-derived Subclinical Cardiac Injuries After Radiotherapy and Chemotherapy for Breast Cancer
- 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 incidental cardiac irradiation, resulting in an increased risk of various major cardiac events (MCEs). In addition, recent studies indicate that for the treatment of BC, the addition of chemotherapy further enhances the risk of MCEs. Information regarding morphological and functional early subclinical cardiac injuries (ESCIs) induced by chemotherapy and radiotherapy that develop into MCEs is largely lacking in scientific literature. This information is essential towards the development of primary and secondary preventive strategies. The EMIRA prospective cohort has as main objective to identify morphological and functional ESCIs in BC patients treated with adjuvant radiotherapy and chemotherapy.
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 |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac imaging modalities | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cardiac imaging modalities
- description
- Repeat echocardiography (cECHO), cardiac MRI (cMRI) scans and cardiac CT (cCT) scans will be performed to evaluate myocardial dysfunction and deformation; myocardium inclusing tissue abnormalities, cardiac morphology and function and; coronary artery lesions and coronary artery calcium score.
- interventionNames
- Other: Cardiac imaging modalities
Primary outcomes (1)
- measure
- Left Ventricle Global Longitudinal Strain (LV-GLS) assessed by echocardiography
- timeFrame
- 6 and 24 months after radiotherapy with reference to baseline
- description
- Increasement in left ventricle Global Longitudinal Strain (GLS) of at least 5%
Secondary outcomes (3)
- measure
- Changes in myocardial function assessed by echocardiography
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female unilateral BC patients 2. Primary breast conserving surgery or mastectomy for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS) 3. Age between 40-70 years at time of chemotherapy/radiotherapy 4. WHO performance status 0-1 5. Planned radiotherapy to the breast/chest wall with or without the lymph node areas 6. Radiotherapy based on planning CT-scan, using either 3D CRT, (partial) IMRT or (partial) VMAT/RapidArc with or without deep inspiration breath-hold 7. Adjuvant systemic chemotherapy (before or after radiotherapy) 8. Written informed consent Exclusion Criteria: 1. Male BC patients 2. M1 disease (metastatic BC) 3. Previous thoracic or mediastinal radiation 4. Neo-adjuvant chemotherapy not allowed 5. Targeted HER2 therapy not allowed 6. Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation 7. Contraindications to injection of iodinated contrast such as allergy or renal failure 8. Pregnancy or lactation 9. Atrial fibrillation detected during electrocardiogram before chemotherapy/radiotherapy 10. Abnormal echocardiography before chemotherapy/radiotherapy defined as: LVEF \<50%, longitudinal strain \<-16%, longitudinal strain rate \<-1%, and/or abnormal wall motion 11. Presence of myocardial infarction detected during cMRI before chemotherapy/radiotherapy 12. cMRI or cCT results before chemotherapy/radiotherapy requiring revascularisation
References
Publications (0)
Data not yet available