Negative Antiphospholipid Syndrome: a Multicentric Study

Launched by ITALIAN SOCIETY FOR RHEUMATOLOGY · Apr 15, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Negative Antiphospholipid Syndrome: a Multicentric Study" is looking into a condition called Antiphospholipid Syndrome (APS), which can cause problems like blood clots or complications during pregnancy. The main goal of this study is to see how well certain blood tests can help identify APS in patients who have experienced these issues but may not have typical test results. The researchers are particularly interested in patients who have had thrombosis (blood clots) or repeated pregnancy problems, even if their blood tests show negative for common markers usually associated with APS.

To participate in this study, individuals need to be under 65 years old and have experienced either blood clots or pregnancy complications within the last five years. The study includes three groups of patients: those who meet the criteria for APS, those with negative test results but strong signs of APS, and those who have had similar issues but do not show signs of APS. Participants can expect to undergo assessments that will help researchers better understand how to diagnose this condition. It's important to note that individuals with known causes for their blood clots or complications, as well as those who have passed away, are not eligible for this study.

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Eligibility criteria

• INCLUSION CRITERIA:
• • 1. Group 1 \[APS\]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)
• • 2. 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)
• • 3. 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).
• • 4. Age \< 65 years (at event time)
• • 5. Less than 5 years from the first even
• • EXCLUSION CRITERIA
• • 1. Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations
• • 2. Deceased patients
• • 3. Less than 5 years from the first event