Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome

Launched by DUKE UNIVERSITY · Jun 1, 2007

Keywords

ClinConnect Summary

This clinical trial is studying Antiphospholipid Syndrome (APS), a condition where certain proteins in the blood, called antiphospholipid antibodies, can cause serious issues like blood clots, strokes, heart attacks, and problems during pregnancy. The researchers believe that genetics may play a role in who develops APS, so they are looking for people with APS who also have family members affected by the syndrome or other autoimmune diseases. The goal is to find out if there are inherited factors that increase the risk of developing APS.

To join the study, participants need to have specific signs of APS, such as having high levels of antiphospholipid antibodies in their blood or experiencing certain health issues like blood clots or pregnancy complications. People with high antibody levels but who don't meet all the APS criteria may also be eligible if they have affected family members. The study is currently recruiting participants of all ages and genders. If you qualify and choose to participate, you'll help researchers learn more about the genetic risks associated with APS, which could improve understanding and treatment in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Persistent presence of an antiphospholipid antibody, as defined by one or both of the following criteria:
• • 1. Medium or high anticardiolipin antibody level in the blood on two or more occasions at least 6 weeks apart
• • 2. Presence of lupus anticoagulant in the plasma on two or more occasions at least 6 weeks apart
• * Presence of clinical symptoms seen in patients with APS, including vascular thrombosis (one or more clinical episodes of arterial, venous, or small vessel thrombosis in any tissue or organ) and/or pregnancy morbidity, defined as any of the following:
• • 1. One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetus morphology documented by ultrasound or direct examination or the fetus
• • 2. One or more premature births of a morphologically normal baby at or before the 34th week of gestation because of severe pre-eclampsia, eclampsia, or severe placental insufficiency
• • 3. Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded
• • People who have elevated antiphospholipid antibody levels but do not fully meet clinical criteria for APS, and do have affected family members, will be considered for enrollment
• Exclusion Criteria:
• • No documented presence of antiphospholipid antibody