SpeckleAnthra2: Prediction of Delayed Toxic Cardiomyopathy in Children
Study Details
Study Description
Brief Summary
Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography" STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Anthracycline therapy may have short-, medium- or long-term cardiac toxicity that impacts patient's life. The main recognized risk factors for delayed cardiotoxicity are cumulative anthracycline dose, female gender, association with mediastinal radiotherapy and young age at administration. Prediction of delayed cardiotoxicity in children population is still challenging.
The "Speckle Tracking Echocardiography" (STE) method, an innovative echocardiographic technique, analyses the myocardial displacement of natural acoustic markers via a software. The objective of the study is to analyze, in young patients who received anthracycline therapy in childhood, 5-years after their inclusion in the "Speckle Anthra" study and first STE results, the evolution of myocardial function using STE method.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anthra2 Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787) |
Diagnostic Test: cardiac ultrasound with speckle tracking analysis
Experimental group: cardiac ultrasound with speckle tracking analysis done during a regular cardiac visit planned after receiving cardiotoxic chemotherapy in childhood.
Control group: cardiac ultrasound with speckle tracking analysis done during a cardiac visit for minor symptoms (murmur, physical aptitude).
Advocated Tomtec software will be used to make post-processing speckle tracking analysis based on 2D ultrasound cineloop acquired during a standard echocardiography.
|
| Active Comparator: Control Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group |
Diagnostic Test: cardiac ultrasound with speckle tracking analysis
Experimental group: cardiac ultrasound with speckle tracking analysis done during a regular cardiac visit planned after receiving cardiotoxic chemotherapy in childhood.
Control group: cardiac ultrasound with speckle tracking analysis done during a cardiac visit for minor symptoms (murmur, physical aptitude).
Advocated Tomtec software will be used to make post-processing speckle tracking analysis based on 2D ultrasound cineloop acquired during a standard echocardiography.
|
Outcome Measures
Primary Outcome Measures
- Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software. [5 years]
To compare the evolution at 5 years ("Anthra2" study timeframe) of LVGLS obtained by STE analysis on patients treated with anthracyclines in childhood and previously included in first "Speckle Anthra" study, with the normal evolution of this parameter with age in healthy matched volunteers.
Secondary Outcome Measures
- Left Ventricle Ejection fraction (LVEF) by Simpson method (%) [The day of inclusion]
Compare the standard ultrasound parameter LVEF and the LVGLS obtained in "Speckle Anthra 2" on patients treated with anthracyclines in childhood and in the group of healthy volunteers.
- Left ventricular myocardial dysfunction defined by LVEF < 55% [5 years]
Correlation between the left ventricular myocardial dysfunction is defined by FeVG < 55% and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study
- Death secondary to toxic cardiomyopathy [5 years]
Correlation between the rate of patients died with a toxic cardiomyopathy and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study
Other Outcome Measures
- Known risk factors for cardiotoxicity [the day of inclusion]
To assess the effect of known risk factors for anthracycline cardiotoxicity, the anthracycline cumulative dose will be collected
- Troponin T on the experimental group [The day of inclusion]
Troponin T is a biological markers of cardiotoxicity obtained in a standard blood test analysis and expressed in ng/ml. normal troponin value is between 0 and 0.04 ng/mL
- NT-pro-BNP on the experimental group [The day of inclusion]
NT-pro-BNP (N terminal-pro-brain natriuretic peptides) is a biological markers of cardiotoxicity obtained in a standard blood test analysis and expressed in pg/ml. Normal NT-proBNP value is < 400pg/ml
- Known risk factors for cardiotoxicity [the day of inclusion]
To assess the effect of known risk factors for anthracycline cardiotoxicity, young age at administration will be collected
- Known risk factors for cardiotoxicity [the day of inclusion]
To assess the effect of known risk factors for anthracycline cardiotoxicity, female gender, will be collected
- Known risk factors for cardiotoxicity [The day of inclusion]
To assess the effect of known risk factors for anthracycline cardiotoxicity, association with mediastinal radiotherapy will be collected
Eligibility Criteria
Criteria
ANTHRA GROUP
Inclusion Criteria:
-
Patients who were treated with anthracyclines for malignant disease between the ages of 0 and 18
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Patient aged 11 to 27 years
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Included in the "SpeckleAnthra" Study (NCT02893787)
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Discontinued chemotherapy for more than 6 years
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Patient in remission of malignant disease
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Enrolled in a social security plan
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Written informed consent from at least one legal representative for the minor patient/ Written informed consent for patients of legal age
Exclusion Criteria:
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Onset of active malignancy or recurrence of malignancy after the "Speckle Anthra" study that required resumption of chemotherapy or mediastinal radiotherapy.
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Chronic cardiac, pulmonary or muscular pathology of etiology other than secondary to anthracycline therapy
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For adult patients: subject under guardianship or curators
CONTROL GROUP
Inclusion Criteria:
-
Control patient included in the "Speckle Control" study (NCT02056925)
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Had a cardiological consultation with echocardiography performed for a banal reason (heart murmur test, cardiological symptoms) and whose result was normal
-
No chronic disease or long-term drug treatment
Exclusion Criteria:
- Refusal to participate in the study by the patient and/or parents or legal guardian after receipt of the study's information and non-objection note.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: VINCENTI Marie, PH, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
- RECHMPL22_0513