NCT00482794 Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome
| NCT ID | NCT00482794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Antiphospholipid Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,800 participants |
| Start Date | 2006-06 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,800 participants in total. It began in 2006-06 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Thomas L. Ortel, MD, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT00482794 clinical trial?
This trial is open to participants of all sexes, studying Antiphospholipid Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00482794 currently recruiting?
Yes, NCT00482794 is actively recruiting participants. Contact the research team at thomas.ortel@duke.edu for enrollment information.
Where is the NCT00482794 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT00482794 clinical trial?
NCT00482794 is sponsored by Duke University. The principal investigator is Thomas L. Ortel, MD, PhD at Duke University. The trial plans to enroll 2,800 participants.