Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorDuke University

About this trial

Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid antibodies, which are proteins in the blood that interfere with the body's ability to perform normal blood clotting. Clinical problems associated with antiphospholipid antibodies include an increased risk for the formation of blood clots in the lungs or deep veins of the legs, stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS have a genetic predisposition for developing the syndrome. This study will use a genetic strategy to identify potential inherited risk factors for the development of APS by recruiting people with APS who have family members also affected by the syndrome or by another autoimmune disorder, such as lupus or rheumatoid arthritis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Medium or high anticardiolipin antibody level in the blood on two or more occasions at least 6 weeks apart

Presence of lupus anticoagulant in the plasma on two or more occasions at least 6 weeks apart

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

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

Disqualifiers

No documented presence of antiphospholipid antibody

Trial population

Individuals with antiphospholipid antibody syndrome and their family members

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,800 Participants
are grouped into 3 trial groups
Group A: 1
Group B: 2
Group C: 3

Trial outcomes

Primary outcomes

1

characterize genetic risk factors associated with the development of familial antiphospholipid antibody syndrome.

Time frame
duration of the study

Secondary outcomes

Other outcomes

Sponsors and contacts

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