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Sponsored by: |
University of New Mexico |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00858884 |
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).
Condition | Intervention |
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Systemic Lupus Erythematosus |
Procedure: Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus |
Enrollment: | 68 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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)
United States, New Mexico | |
University of New Mexico Health Sciences Center | |
Albuquerque, New Mexico, United States, MSC 10 5550 |
Principal Investigator: | Carlos A Roldan, M.D. | University of New Mexico |
Responsible Party: | University of New Mexico Scool of Medicine, Department of Medicine ( Carlos A. Roldan, M.D., Principal Investigator ) |
Study ID Numbers: | HRRC# 06-117, 1R01-HLO77422-3 |
Study First Received: | March 9, 2009 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00858884 History of Changes |
Health Authority: | United States: Institutional Review Board |
Systemic lupus erythematosus Libman-Sacks endocarditis Stroke Transient ischemic attack |
Neuropsychiatric systemic lupus erythematosus Transesophageal echocardiography Magnetic resonance imaging |
Ischemic Attack, Transient Vasculitis Heart Diseases Autoimmune Diseases Cerebral Infarction Lupus Stroke Vascular Diseases Central Nervous System Diseases Lupus Vasculitis, Central Nervous System |
Ischemia Brain Diseases Cerebrovascular Disorders Encephalitis Meningitis Endocarditis Central Nervous System Infections Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases of the Nervous System |
Vasculitis Heart Diseases Autoimmune Diseases Immune System Diseases Meningoencephalitis Nervous System Diseases Vascular Diseases Central Nervous System Diseases Lupus Vasculitis, Central Nervous System Vasculitis, Central Nervous System |
Brain Diseases Cerebrovascular Disorders Encephalitis Meningitis Endocarditis Central Nervous System Infections Lupus Erythematosus, Systemic Connective Tissue Diseases Cardiovascular Diseases Autoimmune Diseases of the Nervous System |