Early Detection of Imaging-derived Subclinical Cardiac Injuries

NCT03575650 | Recruiting DMC

• 1 other identifier: 2018-06
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Left Ventricle Global Longitudinal Strain (LV-GLS) assessed by echocardiography

  Increasement in left ventricle Global Longitudinal Strain (GLS) of at least 5%

  6 and 24 months after radiotherapy with reference to baseline

Secondary Outcomes (3)

• Changes in myocardial function assessed by echocardiography

  6 and 24 after completion of radiotherapy with reference to baseline

• Anatomical changes in coronary arteries by cardiac CT

  6 and 24 after completion of radiotherapy with reference to baseline

• Myocardial tissue abnormalities assessed by cardiac MRI

  6 and 24 after completion of radiotherapy with reference to baseline

Study Arms (1)

Cardiac imaging modalities

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.

Other: Cardiac imaging modalities

Interventions

Cardiac imaging modalities OTHER

Repeat cardiac echocardiographies, MRI-scans and CT-scans for early subclinical biomarker assessments in breast cancer patients treated with chemotherapy and radiotherapy

Cardiac imaging modalities

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with unilateral BC aged 40-75 years who underwent primary surgery, either by mastectomy or by breast conserving surgery, who are treated with adjuvant radiotherapy and chemotherapy as part of routine clinical care.

You may qualify if:

• Female unilateral BC patients
• Primary breast conserving surgery or mastectomy for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
• Age between 40-70 years at time of chemotherapy/radiotherapy
• WHO performance status 0-1
• Planned radiotherapy to the breast/chest wall with or without the lymph node areas
• Radiotherapy based on planning CT-scan, using either 3D CRT, (partial) IMRT or (partial) VMAT/RapidArc with or without deep inspiration breath-hold
• Adjuvant systemic chemotherapy (before or after radiotherapy)
• Written informed consent

You may not qualify if:

• Male BC patients
• M1 disease (metastatic BC)
• Previous thoracic or mediastinal radiation
• Neo-adjuvant chemotherapy not allowed
• Targeted HER2 therapy not allowed
• Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
• Contraindications to injection of iodinated contrast such as allergy or renal failure
• Pregnancy or lactation
• Atrial fibrillation detected during electrocardiogram before chemotherapy/radiotherapy
• Abnormal echocardiography before chemotherapy/radiotherapy defined as: LVEF \<50%, longitudinal strain \<-16%, longitudinal strain rate \<-1%, and/or abnormal wall motion
• Presence of myocardial infarction detected during cMRI before chemotherapy/radiotherapy
• cMRI or cCT results before chemotherapy/radiotherapy requiring revascularisation

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Utrecht University: collaborator

Study Sites (1)

UMCG

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Hans Langendijk, Prof.Dr

  University Medical Center Groningen

  STUDY CHAIR

Central Study Contacts

Anne Crijns, MD, PhD

CONTACT

+31503616161; a.p.g.crijns@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 2, 2018
• Study Start: January 24, 2019
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)