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Tracking Information | |||||
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First Received Date † | March 9, 2009 | ||||
Last Updated Date | March 9, 2009 | ||||
Start Date † | August 2006 | ||||
Current Primary Outcome Measures † |
To determine cross-sectionally in SLE subjects the effects of valve vegetations on the presence of active cerebral microemboli, altered perfusion, ischemic brain lesions, and NPSLE. Findings in patients will be compared to those in controls. [ Time Frame: 4 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
To determine longitudinally in patients with new or recurrent NPSLE if during remission vegetations, cerebral microemboli, and abnormal cerebral perfusion improve, or normalize as compared to baseline data in patients without NPSLE or matched controls. [ Time Frame: 4 years ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus | ||||
Official Title † | Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus | ||||
Brief Summary | The purpose of this study is to determine whether Libman-Sacks endocarditis (inflammation of the heart valves) is the cause of neuropsychiatric manifestations (stroke, transient ischemic attacks, cognitive dysfunction, seizures, acute confusional state, or psychosis) in patients with systemic lupus erythematosus. Hypothesis of the study: Libman-Sacks endocarditis (especially valve vegetations or "small valve growths") generate macro (large) and micro (tiny) emboli that occlude the medium and small cerebral vessels resulting in altered perfusion, ischemic brain injury, and major NPSLE (stroke, TIA, seizures, cognitive dysfunction, acute confusional state, or psychosis). |
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Detailed Description | Specific Aim 1: To determine cross-sectionally in SLE subjects the effects of valve vegetations detected by TEE on the presence of active cerebral microemboli, altered perfusion, ischemic brain lesions, and NPSLE. Findings in SLE patients will be compared to those in controls. Specific Aim 2: To determine longitudinally in patients with new or recurrent NPSLE and during remission whether valve vegetations, active cerebral microemboli, and abnormal cerebral perfusion improve, or normalize when compared to baseline data in patients without NPSLE or matched controls. Specific Aim 3: To determine cross-sectionally in SLE subjects the presence of active cerebral microemboli, altered brain perfusion, brain injury, and NPSLE in relation to other valve abnormalities, such as valve thickening or valve regurgitation, in addition to or independently of valve vegetations; and to determine longitudinally these relationships in patients with NPSLE. Findings in SLE patients will be compared to baseline data in patients without NPSLE or matched controls. Our SLE/NPSLE cohort of >400 subjects and our extensive cardiac and neuroimaging experience with TEE and MR-based techniques are essential resources for this study. We will integrate inflammatory and hemostatic parameters with multiple imaging modalities to investigate the causal connection between valve vegetations and the generation of microemboli and perfusion abnormalities, which then result in brain injury and NPSLE. A causal connection of valve vegetations to brain injury and NPSLE would result in a fundamental shift in the understanding of the pathogenesis, diagnosis, and therapy of Libman-Sacks endocarditis and NPSLE. These findings may extend to other inflammatory diseases associated with valve disease and complicated with central nervous system disease. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic | ||||
Condition † | Systemic Lupus Erythematosus | ||||
Intervention † | Procedure: Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Enrolling by invitation | ||||
Enrollment † | 68 | ||||
Estimated Completion Date | August 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Moreover, the number of children below 18 with SLE is so low in our population as to not provide a statistically viable result.
Patients with supratherapeutic INR (>3.5) will not undergo TEE until INR <3.5. 11)
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00858884 | ||||
Responsible Party | Carlos A. Roldan, M.D., Principal Investigator, University of New Mexico Scool of Medicine, Department of Medicine | ||||
Secondary IDs †† | 1R01-HLO77422-3 | ||||
Study Sponsor † | University of New Mexico | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | University of New Mexico | ||||
Verification Date | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |