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

Completed

• Conditions: Iron Overload

• Registration Number: NCT00629291
• Lead Sponsor: Sheba Medical Center

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.

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

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Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-05
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-09
• Last Update Posted: 2010-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions.

Exclusion Criteria

• contraindication to MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
outcome measure: iron overload on T2* MRI in the heart , liver and pancreas.	1 year

Trial Locations

Locations (1)

Sheba Medical Center , Imaging Dept; 🇮🇱 Tel Hashomer, Israel