Iron Mediated Vascular Disease in Sickle Cell Anemia Patients

NCT ID: NCT01239901

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2018-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Sickle Cell Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Age > 13 years
• Documented diagnosis of sickle cell anemia (SS, SC, Sß0, Sß+)
• Transfused no more than 8 times in a year.

Exclusion Criteria

• Cardiac pacemaker, implantable neurostimulator or other MRI incompatible device.
• History of extreme claustrophobia in MRI machine or other reason for inability to do MRI without sedation.
• Inability to be positioned on the MRI table for sufficient time to complete the MRI exams.
• Any medical or psychological condition that, in the opinion of the local investigator, would make it unsafe or ill-advised for the subject to participate.
• Currently not receiving chronic transfusion therapy, defined as greater than 8 transfusions per year.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

John C. Wood

Associate Professor of Pediatrics - Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Wood, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

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Other Identifiers

1RC1HL099412-01

Identifier Type: NIH

Identifier Source: org_study_id

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