Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus
NCT ID: NCT00858884
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2006-08-31
2006-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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No intevention
No intervention
Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain
All participating subjects (patients with and without neuropsychiatric SLE and healthy controls) will undergo clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain
Interventions
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Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain
All participating subjects (patients with and without neuropsychiatric SLE and healthy controls) will undergo clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients (\> 18 and \< 60 years old) with new or recurrent major NPSLE
* Healthy volunteers based on history and physical examination
* Because of conscious sedation and the MR aspects of the study, women of childbearing potential who agree to participate will require to be on contraception therapy, had undergone an sterilization procedure, or have a negative pregnancy test for their inclusion in the study.
Exclusion Criteria
* Subjects older than 60 years will also be excluded because their high prevalence and incidence of aging related valve and brain pathology and neurocognitive dysfunction.
* Pregnant women will not be studied because of the need of conscious sedation during TEE and the MR aspects of the study. Women of childbearing potential who agree to participate and are not on contraception therapy or have not undergone an sterilization procedure will require a negative pregnancy test before their inclusion in the study.
* Patients with known or suspected valve or cardiac disease unrelated to SLE such as rheumatic valve disease, active or healed infective endocarditis, congenital bicuspid aortic valves, myxomatous mitral valves with prolapse, and those with prosthetic valves and/or sustained atrial fibrillation or flutter will be excluded.
* Patients with a known cardiac substrate for embolism (LV or LA thrombi, LV aneurysm, LV ejection fraction \<40% will be excluded on enrollment, but the development of these complications during the study will be noted and considered as a separate variable.
* Patients with non-SLE related cardiovascular or CNS disease such as congenital hypercoagulability syndromes, hypertensive encephalopathy, CNS infection, metabolic disturbances, hepatic failure, uncontrolled diabetes, or patients who are medicated with neuroleptic drugs.
* Patients with serious medical illness unsuitable for undergoing TEE and MRI scanning.
* Patients with thrombotic thrombocytopenic purpura (TTP).
* Patients with contraindications to esophageal intubation (i.e. esophageal stricture or esophageal varices).
* Patients at risk for hazard due to magnetic fields will be excluded. In critically ill patients TEE will be postponed until medically stable. Patients with supratherapeutic INR (\>3.5) will not undergo TEE until INR \<3.5. 11)
* Patients without NPSLE on warfarin at the entry phase of the study.
* History of head trauma in the form of concussion or contusion.
18 Years
60 Years
ALL
Yes
Sponsors
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University of New Mexico
OTHER
Responsible Party
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Principal Investigators
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Carlos A Roldan, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Countries
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References
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Roldan CA. Valvular and coronary heart disease in systemic inflammatory diseases: Systemic Disorders in heart disease. Heart. 2008 Aug;94(8):1089-101. doi: 10.1136/hrt.2007.132787. No abstract available.
Roldan CA, Qualls CR, Sopko KS, Sibbitt WL Jr. Transthoracic versus transesophageal echocardiography for detection of Libman-Sacks endocarditis: a randomized controlled study. J Rheumatol. 2008 Feb;35(2):224-9. Epub 2007 Dec 15.
Roldan CA, Gelgand EA, Qualls CR, Sibbitt WL Jr. Valvular heart disease by transthoracic echocardiography is associated with focal brain injury and central neuropsychiatric systemic lupus erythematosus. Cardiology. 2007;108(4):331-7. doi: 10.1159/000099104. Epub 2007 Feb 12.
Roldan CA, Gelgand EA, Qualls CR, Sibbitt WL Jr. Valvular heart disease is associated with nonfocal neuropsychiatric systemic lupus erythematosus. J Clin Rheumatol. 2006 Feb;12(1):3-10. doi: 10.1097/01.rhu.0000200378.42836.7f.
Roldan CA, Gelgand EA, Qualls CR, Sibbitt WL Jr. Valvular heart disease as a cause of cerebrovascular disease in patients with systemic lupus erythematosus. Am J Cardiol. 2005 Jun 15;95(12):1441-7. doi: 10.1016/j.amjcard.2005.02.010.
Roldan CA. Valvular disease associated with systemic illness. Cardiol Clin. 1998 Aug;16(3):531-50. doi: 10.1016/s0733-8651(05)70030-8.
Roldan CA, Shively BK, Crawford MH. An echocardiographic study of valvular heart disease associated with systemic lupus erythematosus. N Engl J Med. 1996 Nov 7;335(19):1424-30. doi: 10.1056/NEJM199611073351903.
Roldan CA, Shively BK, Lau CC, Gurule FT, Smith EA, Crawford MH. Systemic lupus erythematosus valve disease by transesophageal echocardiography and the role of antiphospholipid antibodies. J Am Coll Cardiol. 1992 Nov 1;20(5):1127-34. doi: 10.1016/0735-1097(92)90368-w.
Sibbitt WL Jr, Schmidt PJ, Hart BL, Brooks WM. Fluid Attenuated Inversion Recovery (FLAIR) imaging in neuropsychiatric systemic lupus erythematosus. J Rheumatol. 2003 Sep;30(9):1983-9.
Sibbitt WL Jr, Brandt JR, Johnson CR, Maldonado ME, Patel SR, Ford CC, Bankhurst AD, Brooks WM. The incidence and prevalence of neuropsychiatric syndromes in pediatric onset systemic lupus erythematosus. J Rheumatol. 2002 Jul;29(7):1536-42.
Sibbitt WL Jr, Sibbitt RR, Brooks WM. Neuroimaging in neuropsychiatric systemic lupus erythematosus. Arthritis Rheum. 1999 Oct;42(10):2026-38. doi: 10.1002/1529-0131(199910)42:103.0.CO;2-J. No abstract available.
Sibbitt WL Jr, Jung RE, Brooks WM. Neuropsychiatric systemic lupus erythematosus. Compr Ther. 1999 Apr;25(4):198-208. doi: 10.1007/BF02889620.
Sibbitt WL Jr, Haseler LJ, Griffey RR, Friedman SD, Brooks WM. Neurometabolism of active neuropsychiatric lupus determined with proton MR spectroscopy. AJNR Am J Neuroradiol. 1997 Aug;18(7):1271-7.
Roldan CA, Joson J, Qualls CR, Sharrar J, Sibbitt WL Jr. Premature aortic stiffness in systemic lupus erythematosus by transesophageal echocardiography. Lupus. 2010 Dec;19(14):1599-605. doi: 10.1177/0961203310377088. Epub 2010 Sep 2.
Other Identifiers
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HRRC# 06-117
Identifier Type: -
Identifier Source: org_study_id
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