Myocardial FunctionSPECKLEANTHRANCT02893787
Study of Myocardial Function by Speckle Tracking After Cancer Treatment With Anthracyclines in Childhood
An observational study of Myocardial Function and Echographic Parameters Obtaind by Speckle Tracking, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main goal of this study is to compare the values of echocardiographic parameters obtained by Speckle Traking analysis on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Function, Echographic Parameters Obtaind by Speckle Tracking, Chilhood Cancers
- What is being tested?
- Speckle Tracking Echocardiography
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2017
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients under 18 years treated with anthracyclines in childhood and healthy age and sex mached volunteers.
Who may be able to join
- Patient treated between 0 and 18 with anthracyclines for malignancy
- Discontinuation of treatment with chemotherapy for over 1 year
- Patient in remission of his malignancy
- Lack of heart or lung disease associated
- No opposition patient and legal guardian
- Patient younger than 18 at the time of the study.
Who cannot join
- Progressive malignant pathology.
- Cardiac, lung or muscle chronic diseases, etiology other than secondary to treatment with anthracyclines
- Refusal to participate in the study
- Poor echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to compare the values of echocardiographic parameters obtained by Speckle Traking analysis on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers.
Read the detailed description
Anthracyclines are major drugs in the treatment of childhood cancers. The main factor limiting their use is the occurrence of delayed cardiac toxicity, irreversible, in an dilated form of potentially fatal cardiomyopathy. This delayed cardiotoxicity secondary to the destruction of myocardial cells is histologically proven after administration of the first dose of anthracyclines. The main known risks factors for delayed cardiotoxicity are: the cumulative dose of anthracyclines, young age at the time of administration, and association with mediastinal radiotherapy. All pediatric protocols with anthracyclines therefore provide a prolonged cardiac monitoring.
However, there are no validated predictive early markers of progression to cardiomyopathy:
- the standard echocardiography, routine surveillance method does not detect subclinical myocardial injury, ii) the predictive value of biomarkers (ultrasensitive troponin, NT-pro-BNP) is controversial because of conflicting results.
Among the echocardiographic innovative techniques, myocardial strain imaging by speckle tracking echocardiography analyses via a software myocardial displacement of natural acoustic markers, and enables rapid evaluation, precise and objective of the segmental and global myocardial function, expressed as a percentage (strain) and speed of myocardial deformation (strain rate) by reference segment and by reference dimension (longitudinal, radial, circumferential).
Only four recent studies analysing the myocardic function in ST of the patients treated with anthracyclines in childhood (Yiu-fai, Cheung, Yu W, Poterucha) find unmatched and/or incomplete results, on a limited number of patients, but suggest the existence of alterations of the left ventricle the strain before the appearance of deteriorations of the fraction of ejection of the left ventricle (LVEF). None of these studies studied the strain of the right ventricle and none compared the data of the strain with the cardiac biomarkers.
Primary objective
Compare the values of echocardiographic parameters obtained by the technique of ST on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers.
Secondary objectives
To compare conventional echocardiographic parameters and ST them in terms of deviation from the norm To assess the impact of known risk factors for cardiotoxicity with anthracyclines (cumulative dose, young age at administration, female association with mediastinal radiotherapy) on ultrasound parameters obtained by the technique of ST.
To evaluate the association between biomarkers for cardiotoxicity (ultrasensitive troponin and NT-pro-BNP) and echocardiographic parameters obtained by the technique of ST.
To correlate indices of Speckle Tracking methods to classical sonographic data
- Being tested
- Speckle Tracking Echocardiography
- Keywords
- Speckle Tracking, Anthracyclines, Chilhood cancers, Myocardial function, Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speckle Tracking EchocardiographyOther
Echocardiography analyses
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with anthracyclines in childhood | Not described Receives: Other: Speckle Tracking Echocardiography | |
| Healthy volunteers | Not described Receives: Other: Speckle Tracking Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic parameters obtained by Speckle Tracking
Measured: Immediat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure SAUMET, DR, Principal investigator, Hôpital Arnaud de Villeneuve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893787
- Sponsor's protocol ID
- 9396
- Acronym
- SPECKLEANTHRA
- Status last verified
- Feb 2022
- First submitted
- 5 Aug 2016
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Amedro P, Vincenti M, Abassi H, Lanot N, De La Villeon G, Guillaumont S, Gamon L, Mura T, Lopez-Perrin K, Haouy S, Sirvent A, Cazorla O, Vergely L, Lacampagne A, Avesani M, Sirvent N, Saumet L. Use of speckle tracking echocardiography to detect late anthracycline-induced cardiotoxicity in childhood cancer: A prospective controlled cross-sectional study. Int J Cardiol. 2022 May 1;354:75-83. doi: 10.1016/j.ijcard.2022.02.012. Epub 2022 Feb 12.
PubMed 35167907
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Myocardial Function by Speckle Tracking After Cancer Treatment With Anthracyclines in Childhood
- ClinicalTrials.gov ID
- NCT02893787
- Acronym / sponsor ID
- SPECKLEANTHRA / 9396
- Keywords
- Speckle Tracking, Anthracyclines, Chilhood cancers, Myocardial function, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
The main goal of this study is to compare the values of echocardiographic parameters obtained by Speckle Traking analysis on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers.
Detailed description
Anthracyclines are major drugs in the treatment of childhood cancers. The main factor limiting their use is the occurrence of delayed cardiac toxicity, irreversible, in an dilated form of potentially fatal cardiomyopathy. This delayed cardiotoxicity secondary to the destruction of myocardial cells is histologically proven after administration of the first dose of anthracyclines. The main known risks factors for delayed cardiotoxicity are: the cumulative dose of anthracyclines, young age at the time of administration, and association with mediastinal radiotherapy. All pediatric protocols with anthracyclines therefore provide a prolonged cardiac monitoring.
However, there are no validated predictive early markers of progression to cardiomyopathy:
- the standard echocardiography, routine surveillance method does not detect subclinical myocardial injury, ii) the predictive value of biomarkers (ultrasensitive troponin, NT-pro-BNP) is controversial because of conflicting results.
Among the echocardiographic innovative techniques, myocardial strain imaging by speckle tracking echocardiography analyses via a software myocardial displacement of natural acoustic markers, and enables rapid evaluation, precise and objective of the segmental and global myocardial function, expressed as a percentage (strain) and speed of myocardial deformation (strain rate) by reference segment and by reference dimension (longitudinal, radial, circumferential).
Only four recent studies analysing the myocardic function in ST of the patients treated with anthracyclines in childhood (Yiu-fai, Cheung, Yu W, Poterucha) find unmatched and/or incomplete results, on a limited number of patients, but suggest the existence of alterations of the left ventricle the strain before the appearance of deteriorations of the fraction of ejection of the left ventricle (LVEF). None of these studies studied the strain of the right ventricle and none compared the data of the strain with the cardiac biomarkers.
Primary objective
Compare the values of echocardiographic parameters obtained by the technique of ST on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers.
Secondary objectives
To compare conventional echocardiographic parameters and ST them in terms of deviation from the norm To assess the impact of known risk factors for cardiotoxicity with anthracyclines (cumulative dose, young age at administration, female association with mediastinal radiotherapy) on ultrasound parameters obtained by the technique of ST.
To evaluate the association between biomarkers for cardiotoxicity (ultrasensitive troponin and NT-pro-BNP) and echocardiographic parameters obtained by the technique of ST.
To correlate indices of Speckle Tracking methods to classical sonographic data
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with anthracyclines in childhood | – | Other: Speckle Tracking Echocardiography |
| Healthy volunteers | – | Other: Speckle Tracking Echocardiography |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients under 18 years treated with anthracyclines in childhood and healthy age and sex mached volunteers.
Key inclusion criteria (6 listed)
- Patient treated between 0 and 18 with anthracyclines for malignancy
- Discontinuation of treatment with chemotherapy for over 1 year
- Patient in remission of his malignancy
- Lack of heart or lung disease associated
- No opposition patient and legal guardian
Key exclusion criteria (4 listed)
- Progressive malignant pathology.
- Cardiac, lung or muscle chronic diseases, etiology other than secondary to treatment with anthracyclines
- Refusal to participate in the study
- Poor echogenicity
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 |
|---|---|---|
| Speckle Tracking EchocardiographyEchocardiography analyses | Other | Healthy volunteers, Patients treated with anthracyclines in childhood |
Primary outcome
Echocardiographic parameters obtained by Speckle Tracking
Time frame: Immediat
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Results publication: PubMed 35167907Amedro P, Vincenti M, Abassi H, Lanot N, De La Villeon G, Guillaumont S, Gamon L, Mura T, Lopez-Perrin K, Haouy S, Sirvent A, Cazorla O, Vergely L, Lacampagne A, Avesani M, Sirvent N, Saumet L. Use of speckle tracking echocardiography to detect late anthracycline-induced cardiotoxicity in childhood cancer: A prospective controlled cross-sectional study. Int J Cardiol. 2022 May 1;354:75-83. doi: 10.1016/j.ijcard.2022.02.012. Epub 2022 Feb 12.
- 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.
Laure SAUMET, DR principal investigator
Hôpital Arnaud de Villeneuve
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 Myocardial Function and Echographic Parameters Obtaind by Speckle Tracking, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 14 Mar 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic parameters obtained by Speckle Tracking (time frame: Immediat). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893787, which also lists 1 linked publication.
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 14 Mar 2022.