The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 23, 2007 | ||||||||
| Last Updated Date | April 3, 2007 | ||||||||
| Start Date ICMJE | July 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00451919 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease | ||||||||
| Official Title ICMJE | Sickle-Cell Disease: Neuroimaging and Cognitive Decline | ||||||||
| Brief Summary | Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs). People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs are responsible for carrying oxygen to the brain and other body tissues that need oxygen to function properly. The purpose of this study is to determine what changes, which were possibly caused by anemia, exist in the brains of individuals with sickle cell disease. |
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| Detailed Description | The role of RBCs is to carry oxygen from the lungs to the brain and other body tissues. Individuals with anemia have unusually low numbers of RBCs. They also often have difficulty concentrating and remembering information, which is likely caused by a reduced oxygen supply to the brain. Previous research has shown that correcting anemia in patients without sickle cell disease improved their memory and attention. The purpose of this study is to examine any abnormal changes in the brains of individuals with sickle cell disease and to determine whether these changes are related to reduced memory and attention capabilities. Participants will attend one study visit. During this visit, a brain magnetic resonance image (MRI) will be performed while participants complete neuropsychological tests that measure memory, attention, and organizational ability. There will be no follow-up visits. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Retrospective/Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE | Sickle Cell Disease | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 120 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00451919 | ||||||||
| Other Study ID Numbers ICMJE | 375, K01 HL073152 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators ICMJE | University of California, San Francisco | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Verification Date | March 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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