MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.
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Purpose
Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. Thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.
The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.
| Condition |
|---|
|
Iron Overload |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Evaluation of Iron Overload in the Heart, Liver and Pancreas: Patients With Sickle β Thalassemia and Sickle Cell Anemia. |
- outcome measure: iron overload on T2* MRI in the heart , liver and pancreas. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
No biosepcimens retained
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Sickle cell anemia patients
|
|
2
Sickle cell β thalassemia
|
Detailed Description:
Sickle cell anemia and Sickle cell β thalassemia patients recieving multiple transfusions are exposed to the effects of iron deposition in the reticuloendothelial system, including cardiac muscle, liver and pancreas. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.
The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.
Patients and Methods: 27 Sickle cell anemia and 28 Sickle cell β thalassemia will undergo transthoracic echocardiography, cardiac MRI using T2* sequences and clinical and laboratory evaluation for iron overload including ferritin levels and oral glucose tolerance test
.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Sickle cell anemia and Sickle cell β thalassemia patients from dedicated outpatient hospital clinic.
Inclusion Criteria:
- clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions.
Exclusion Criteria:
- contraindication to MRI
Contacts and Locations More Information
No publications provided
| Responsible Party: | Orly Goitein MD, Sheba medical center |
| ClinicalTrials.gov Identifier: | NCT00629291 History of Changes |
| Other Study ID Numbers: | SHEBA-07-4859-OG-CTIL |
| Study First Received: | February 25, 2008 |
| Last Updated: | May 9, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
iron overload Thalassemia Anemia, Sickle Cell Magnetic Resonance Imaging |
Additional relevant MeSH terms:
|
Thalassemia Iron Overload Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies |
Genetic Diseases, Inborn Iron Metabolism Disorders Metabolic Diseases Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013