Actively Recruiting

All Genders
NCT00482794

Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome

Led by Duke University · Updated on 2025-03-19

2800

Participants Needed

1

Research Sites

1134 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persistent presence of antiphospholipid antibody shown by either medium or high anticardiolipin antibody levels in blood on two or more occasions at least 6 weeks apart or presence of lupus anticoagulant in plasma on two or more occasions at least 6 weeks apart
  • Clinical symptoms of APS including one or more episodes of arterial, venous, or small vessel thrombosis in any tissue or organ
  • Pregnancy problems including unexplained death of a morphologically normal fetus at or beyond 10 weeks, premature birth of a normal baby at or before 34 weeks due to severe pre-eclampsia, eclampsia, or severe placental insufficiency, or three or more unexplained consecutive spontaneous abortions before 10 weeks with other causes excluded
  • People with elevated antiphospholipid antibody levels who do not fully meet clinical criteria for APS but have affected family members
Not Eligible

You will not qualify if you...

  • No documented presence of antiphospholipid antibody

AI-Screening

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Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

T

Thomas L. Ortel, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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