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| Sponsored by: |
Sheba Medical Center |
|---|---|
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00629291 |
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: | Case Control, Prospective |
| Official Title: | Evaluation of Iron Overload in the Heart, Liver and Pancreas: Patients With Sickle β Thalassemia and Sickle Cell Anemia. |
No biosepcimens retained
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | February 2008 |
| Groups/Cohorts |
|---|
|
1
Sickle cell anemia patients
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|
2
Sickle cell β thalassemia
|
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:
Exclusion Criteria:
Contacts and Locations| Israel | |
| Sheba Medical Center , Imaging Dept | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Contact: Orly Goitein, MD 972-52-6666681 orly.goitein@sheba.health.gov.il | |
| Contact: Shimrit Skop 972-3-530-2530 shimrit.skop@sheba.health.gov.il | |
| Principal Investigator: Orly Goitein, MD | |
| Principal Investigator: | Orly Goitein, MD | Sheba Medical Center |
More Information
| Responsible Party: | Sheba medical center ( Orly Goitein MD ) |
| Study ID Numbers: | SHEBA-07-4859-OG-CTIL |
| Study First Received: | February 25, 2008 |
| Last Updated: | February 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00629291 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
iron overload Thalassemia Anemia, Sickle Cell Magnetic Resonance Imaging |
|
Metabolic Diseases Anemia Iron Metabolism Disorders Iron Overload Metabolic disorder |
Pancrelipase Iron Thalassemia Anemia, Sickle Cell Sickle cell anemia |
