What this study is
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.
Study details
- Official title
- Genetics of Antiphospholipid Antibody Syndrome
- Sponsor
- Duke University
- Conditions
- Antiphospholipid Syndrome
- Enrolling
- 2,800 people
- Starts
- 2006-06
- Est. completion
- 2029-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- 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:; 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; 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
You can't join if
- No documented presence of antiphospholipid antibody
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke University Medical Center
Durham, North Carolina, United States
- Thomas L. Ortel, MD, PhD · Principal investigator
- Silke Schmidt, PhD · Principal investigator
Recruiting
Study team
Sponsor
Duke University
Study ID Pro00013845
Principal investigator
Thomas L. Ortel, MD, PhD
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.