Introduction: In primary Sjögren's syndrome (pSS), autoimmune disease characterized primarily by involvement of the exocrine glands, there are reports of patients with the antiphospholipid antibody syndrome (APS). However, in the pSS, it is questionable the association of antiphospholipid antibodies (aPLs) with increased risk of thromboembolic events. In this respect, in the primary or secondary to lupus APS, anticardiolipin antibody (aCL) is characterized by the dependence of the serum cofactor for its binding to the antigen. This feature has not been evaluated in patients with pSS with or without thrombosis. Moreover, in pSS, no prospective studies aimed at non-thrombotic manifestations of APS (such as valvular lesions) and their possible correlations with the aPLs. Nor is it known of the possible association of aPLs with the characteristic clinical manifestations of pSS.Objectives: To study in patients with pSS: the frequency of aPLs; the possible association of these antibodies with the previous or active clinical features of pSS; the prevalence of thrombotic and non-thrombotic manifestations suggestive of APS and their correlations with aPLs; and possible dependency of the serum cofactor for aCL binding to its antigen.Methods: Will be evaluated 75 consecutive patients with pSS (The American-European Consensus Group Criteria) of both sexes and aged 18-65 years and, as controls, 75 healthy volunteers with no complaints of sicca syndrome and matched for sex, race and age. Patients will be assessed using a standardized clinical protocol. Serum samples will be collected from patients and controls for research of aPLs (aCL, lupus anticoagulant and anti-beta-2-glycoprotein 1). aCL will be detected by ELISA in the presence and absence of serum cofactor. It will also be performed echocardiographic evaluation in patients and controls by a blinded examiner.
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