Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations (SUFEMYO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The inevestigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.
The investigators will record concomitantly parameters which, according to literature data, may influence the occurrence of this complication, and will look for correlations with these parameters and iron overload (secondary objectives), in each of the 3 cohorts.
14 centres are involved and enrol patients with thalassemia, or sickle cell disease, or myelodysplasia having received in the past year > 8 erythrocyte concentrates, and having had a cardiac MRI. Patients files register the type of the disease, age at the beginning of transfusion and chelation, chelator type and dosage, liver and cardiac T2*.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Paris, France, 75015
- Hôpital Necker Enfants malades
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Thalassemia, sickle cell disease, myelodysplasia
- having received in the past year > 8 erythrocyte concentrates
- > 6 years of age
Exclusion Criteria:
- preexisting cardiac disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
thalassemia
patients affected with thalassemia
|
a blood sample was taken on the day of inclusion
|
|
sickle cell disease
patients affected with sickle cell disease
|
a blood sample was taken on the day of inclusion
|
|
myelodysplasia
patients affected with myelodysplasia
|
a blood sample was taken on the day of inclusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiac T2* (MRI)
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Liver T2*(MRI)
Time Frame: Day 0
|
Day 0
|
Collaborators and Investigators
Investigators
- Study Director: Mariane de montalembert, MD/PhD, Groupement Hospitalier Necker
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Hematologic Diseases
- Bone Marrow Diseases
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Anemia
- Hemoglobinopathies
- Myelodysplastic Syndromes
- Anemia, Refractory
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Hemic and Lymphatic Diseases
- Anemia, Sickle Cell
- Thalassemia
- Anemia, Refractory, with Excess of Blasts
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- NI10071
- RAF11005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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