Iron Mediated Vascular Disease in Sickle Cell Anemia Patients
Recruitment status was Recruiting
The purpose of this research study is to determine the frequency and severity of iron overload in patients with Sickle Cell Anemia and its relationship to blood vessel function. The investigators hypothesize that intermittent transfusions that these patients receive during hospitalizations produces significant iron overload and impairs blood vessel relaxation.
Sickle Cell Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Iron-mediated Vascular Disease in Sickle Cell Disease.|
- Liver iron concentration (LIC), pancreas R2*, and kidney R2*, measured by MRI [ Time Frame: 15 min MRI done completed during one time study visit ] [ Designated as safety issue: No ]Liver iron concentration (LIC) will be used as a surrogate for total body iron, pancreatic iron represents a surrogate for extravascular iron deposition, and renal iron as a surrogate for chronic intravascular hemolysis. In addition, labile plasma iron will be measured in blood plasma.
- Vascular function. [ Time Frame: Scheduled during one time study visit ] [ Designated as safety issue: No ]Measurements will be done through several procedures: Ultrasound of artery in upper arm, Ultrasound of artery in neck, and blood tests of ascorbate and hydrobiopterins.
Biospecimen Retention: Samples With DNA
Red Blood Cells (RBCs), Peripheral Blood Mononuclear Cells (PBMCs), Plasma, Serum, and Urine
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Patients with sickle cell anemia often require blood transfusion as part of the treatment for their disease. Each teaspoon of transfused blood contains about 5 mg of iron and the levels of iron in sickle cell patients increase rapidly with each transfusion. While iron is necessary for many bodily functions, too much iron damages blood vessels, liver, hormone producing glands (pancreas, pituitary and thyroid) and the heart. It is important to know how iron damages blood vessels because most of the problems experienced by sickle cell anemia patients (stroke, kidney failure, pulmonary hypertension, heart disease) result from blood vessel damage. In this trial, iron in the liver, pancreas, and kidney will be measured noninvasively by MRI while vascular function will be measured by ultrasound and tissue Doppler. Patients will be recruited primarily from the greater Los Angeles area, although patients from greater distances will be allowed to participate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239901
|Contact: Tatiana Hernandez, BAemail@example.com|
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Tatiana Hernandez, BA 323-361-8827 firstname.lastname@example.org|
|Principal Investigator: John C Wood, MD, PhD|
|Sub-Investigator: Thomas D Coates, MD|
|Principal Investigator:||John C Wood, MD, PhD||Children's Hospital Los Angeles|