Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus

NCT00858884 | Withdrawn

• 1 other identifier: HRRC# 06-117
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus; Libman-Sacks endocarditis; Stroke; Transient ischemic attack; Neuropsychiatric systemic lupus erythematosus; Transesophageal echocardiography; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (1)

• 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.

  4 years

Study Arms (1)

No intevention

NO INTERVENTION

No intervention

Other: Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain

Interventions

Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain OTHER

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

Also known as: Clinical and laboratory and imaging tests

No intevention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with diagnosis of SLE according to the American Rheumatology Association independent of gender or ethnicity and recruited from the Rheumatology Clinics at the University of New Mexico Health Sciences Center
• Patients (\> 18 and \< 60 years old) with new or recurrent major NPSLE
• Healthy volunteers based on history and physical examination

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Publications (14)

• 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.

  PMID: 18625800 BACKGROUND

• 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.

  PMID: 18085739 BACKGROUND

• 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.

  PMID: 17299260 BACKGROUND

• 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.

  PMID: 16484873 BACKGROUND

• 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.

  PMID: 15950567 BACKGROUND

• Roldan CA. Valvular disease associated with systemic illness. Cardiol Clin. 1998 Aug;16(3):531-50. doi: 10.1016/s0733-8651(05)70030-8.

  PMID: 9742329 BACKGROUND

• 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.

  PMID: 8875919 BACKGROUND

• 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.

  PMID: 1341885 BACKGROUND

• 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.

  PMID: 12966602 BACKGROUND

• 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.

  PMID: 12136916 BACKGROUND

• 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.

  PMID: 10524673 BACKGROUND

• Sibbitt WL Jr, Jung RE, Brooks WM. Neuropsychiatric systemic lupus erythematosus. Compr Ther. 1999 Apr;25(4):198-208. doi: 10.1007/BF02889620.

  PMID: 10349089 BACKGROUND

• 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.

  PMID: 9282854 BACKGROUND

• 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.

  PMID: 20813797 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Stroke; Ischemic Attack, Transient; Lupus Vasculitis, Central Nervous System

Interventions

Laboratories

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Meningoencephalitis; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Encephalitis; Neuroinflammatory Diseases; Meningitis; Vasculitis

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Carlos A Roldan, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: August 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: January 10, 2024

Record last verified: 2013-06

Locations

US (1)