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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

Tracking Information
First Submitted Date February 25, 2008
First Posted Date March 5, 2008
Last Update Posted Date May 11, 2010
Study Start Date January 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2008)
outcome measure: iron overload on T2* MRI in the heart , liver and pancreas. [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.
Official Title Evaluation of Iron Overload in the Heart, Liver and Pancreas: Patients With Sickle β Thalassemia and Sickle Cell Anemia.
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

.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
No biosepcimens retained
Sampling Method Non-Probability Sample
Study Population Sickle cell anemia and Sickle cell β thalassemia patients from dedicated outpatient hospital clinic.
Condition Iron Overload
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Sickle cell anemia patients
  • 2
    Sickle cell β thalassemia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 25, 2008)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication to MRI
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00629291
Other Study ID Numbers SHEBA-07-4859-OG-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Orly Goitein MD, Sheba medical center
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Orly Goitein, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date May 2010