Cardiovascular DiseasesEMIRANCT03575650
Early Detection of Imaging-derived Subclinical Cardiac Injuries
An observational study of Cardiovascular Diseases, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiac imaging modalities
- How many people
- 148 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2019to 2 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen, 9713GZ
Anne Crijns, MD PhD, +31-652724432, a.p.g.crijns@umcg.nl
About this study
Official title: Early Detection of Imaging-derived Subclinical Cardiac Injuries After Radiotherapy and Chemotherapy for Breast Cancer
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.
Read the detailed description
EMIRA is a single centre prospective observational cohort study performed in the UMCG. The study includes breast cancer patients that underwent primary surgery, either by mastectomy or breast conserving surgery, who are treated with adjuvant radiotherapy and chemotherapy as part of routine clinical care. The patient follow up time continues for 2 years after radiotherapy to identify early subclinical cardiac injuries (ESCIs), using repeat echocardiography (cECHO), cardiac MRI (cMRI) scans and cardiac CT (cCT) scans. The images are acquired prior to chemotherapy and/or radiotherapy (depending on the sequence of adjuvant treatment), and at 6 and 24 months after radiotherapy The first primary aim of this project is to detect ESCIs that are considered risk factors for clinically apparent major cardiac events in breast cancer patients treated with radiotherapy and chemotherapy. The second is to use this information to develop prediction models describing the relationship between the radiation dose to cardiac substructures and ESCIs.
In detail, the investigators aim to:
- identify longitudinal morphological and functional ESCIs using echocardiography, cardiac MRI and cardiac CT before and after BC treatment;
- determine the relationship between 3D-dose distributions to cardiac substructures and ESCI;
- establish the effect of chemotherapy on the dose-effect relationship between radiation dose and ESCI.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiac imaging modalities
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac imaging modalitiesOther
Repeat cardiac echocardiographies, MRI-scans and CT-scans for early subclinical biomarker assessments in breast cancer patients treated with chemotherapy and radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiac imaging modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricle Global Longitudinal Strain (LV-GLS) assessed by echocardiography
Increasement in left ventricle Global Longitudinal Strain (GLS) of at least 5%
Measured: 6 and 24 months after radiotherapy with reference to baseline
Secondary outcomes (3)
Changes in myocardial function assessed by echocardiography
Increasement of segmental strain measurements (unit of measures:%)
Measured: 6 and 24 after completion of radiotherapy with reference to baseline
Anatomical changes in coronary arteries by cardiac CT
Increase in the number of coronary segments containing any plaque/stenosis, or increase in calcium score
Measured: 6 and 24 after completion of radiotherapy with reference to baseline
Myocardial tissue abnormalities assessed by cardiac MRI
Increase of the native mean myocardial T1 mapping value assessed by cardiac MRI
Measured: 6 and 24 after completion of radiotherapy with reference to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start24 Jan 2019
- Primary completion2 Sep 2024 (estimated)
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University
- Responsible party
- Sponsor
- Investigators
- Hans Langendijk, Prof.Dr, Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575650
- Sponsor's protocol ID
- 2018-06
- Acronym
- EMIRA
- Status last verified
- Feb 2024
- First submitted
- 18 Jun 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Imaging-derived Subclinical Cardiac Injuries After Radiotherapy and Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT03575650
- Acronym / sponsor ID
- EMIRA / 2018-06
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Utrecht University
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 2 Sep 2024 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
EMIRA is a single centre prospective observational cohort study performed in the UMCG. The study includes breast cancer patients that underwent primary surgery, either by mastectomy or breast conserving surgery, who are treated with adjuvant radiotherapy and chemotherapy as part of routine clinical care. The patient follow up time continues for 2 years after radiotherapy to identify early subclinical cardiac injuries (ESCIs), using repeat echocardiography (cECHO), cardiac MRI (cMRI) scans and cardiac CT (cCT) scans. The images are acquired prior to chemotherapy and/or radiotherapy (depending on the sequence of adjuvant treatment), and at 6 and 24 months after radiotherapy The first primary aim of this project is to detect ESCIs that are considered risk factors for clinically apparent major cardiac events in breast cancer patients treated with radiotherapy and chemotherapy. The second is to use this information to develop prediction models describing the relationship between the radiation dose to cardiac substructures and ESCIs.
In detail, the investigators aim to:
- identify longitudinal morphological and functional ESCIs using echocardiography, cardiac MRI and cardiac CT before and after BC treatment;
- determine the relationship between 3D-dose distributions to cardiac substructures and ESCI;
- establish the effect of chemotherapy on the dose-effect relationship between radiation dose and ESCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac imaging modalities | – | Other: Cardiac imaging modalitiesRepeat 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Male BC patients
- M1 disease (metastatic BC)
- Previous thoracic or mediastinal radiation
- Neo-adjuvant chemotherapy not allowed
- Targeted HER2 therapy not allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac imaging modalitiesRepeat cardiac echocardiographies, MRI-scans and CT-scans for early subclinical biomarker assessments in breast cancer patients treated with chemotherapy and radiotherapy | Other | Cardiac imaging modalities |
Primary outcome
Left Ventricle Global Longitudinal Strain (LV-GLS) assessed by echocardiography
Time frame: 6 and 24 months after radiotherapy with reference to baseline
Increasement in left ventricle Global Longitudinal Strain (GLS) of at least 5%
3 secondary outcomes
Changes in myocardial function assessed by echocardiography
Time frame: 6 and 24 after completion of radiotherapy with reference to baseline
Anatomical changes in coronary arteries by cardiac CT
Time frame: 6 and 24 after completion of radiotherapy with reference to baseline
Myocardial tissue abnormalities assessed by cardiac MRI
Time frame: 6 and 24 after completion of radiotherapy with reference to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Langendijk, Prof.Dr study chair
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Crijns, MD, PhD (+31503616161, a.p.g.crijns@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricle Global Longitudinal Strain (LV-GLS) assessed by echocardiography (time frame: 6 and 24 months after radiotherapy with reference to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.