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MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00629291
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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Brief Summary:

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 or disease
Iron Overload

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

.

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
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.
Study Start Date : January 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Sickle cell anemia patients
2
Sickle cell β thalassemia


Outcome Measures
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Primary Outcome Measures :
  1. outcome measure: iron overload on T2* MRI in the heart , liver and pancreas. [ Time Frame: 1 year ]

Biospecimen Retention:   None Retained
No biosepcimens retained

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sickle cell anemia and Sickle cell β thalassemia patients from dedicated outpatient hospital clinic.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629291


Locations
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Israel
Sheba Medical Center , Imaging Dept
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Orly Goitein, MD Sheba Medical Center
More Information
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Responsible Party: Orly Goitein MD, Sheba medical center
ClinicalTrials.gov Identifier: NCT00629291    
Other Study ID Numbers: SHEBA-07-4859-OG-CTIL
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: May 11, 2010
Last Verified: May 2010
Keywords provided by Sheba Medical Center:
iron overload
Thalassemia
Anemia, Sickle Cell
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Iron Overload
Iron Metabolism Disorders
Metabolic Diseases