Negative Antiphospholipid Syndrome: a Multicentric Study
Italian Society for Rheumatology
105 participants
Sep 21, 2024
OBSERVATIONAL
Conditions
Summary
Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology. The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.
Eligibility
Inclusion Criteria5
- Group 1 \[APS\]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)
- Group 2 \[SN-APS\]: patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)
- Group 3: patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases).
- Age < 65 years (at event time)
- Less than 5 years from the first even
Exclusion Criteria3
- Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations
- Deceased patients
- Less than 5 years from the first event
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Interventions
To assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/ recurrent adverse pregnancy outcomes
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06373003