Clinical trial NCT00076713: Antiphospholipid Syndrome Collaborative Registry (APSCORE)
Official title: Antiphospholipid Syndrome Collaborative Registry (APSCORE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiphospholipid Syndrome
Keywords: Antiphospholipid
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2004-02-03
Enrollment: 860
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialty and subspecialty clinics

Brief summary: Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. Patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. APS may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals.

The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and tissue repository for patients with APS. This registry will collect clinical information and blood samples from people with APS.

Detailed description: Registry participants will have a blood sample drawn and will be interviewed about their medical histories. Participants will be asked to return for a follow-up visit after two years. Clinical, demographic, and laboratory data will be collected. Registry resources will be made available to researchers and medical practitioners to support a broad range of research on the causes, diagnosis, mechanisms, and treatment of APS.

The University of North Carolina at Chapel Hill is the coordinating center and an enrollment site for the registry. There are seven other enrollment sites: Ball Memorial Hospital, Muncie, IN; Duke University, Durham, NC; Hospital for Special Surgery, New York, NY; Johns Hopkins University, Baltimore, MD; Morehouse School of Medicine, Atlanta, GA; University of Texas Health Science Center, San Antonio, TX; and University of Utah Health Science Center, Salt Lake City, UT.

Eligibility criteria: Inclusion Criteria:

* Antiphospholipid antibodies with or without associated clinical manifestations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Hospital for Special Surgery, Weill-Cornell University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
Study officials:
References:
citation: Roubey RA. New approaches to prevention of thrombosis in the antiphospholipid syndrome: hopes, trials, and tribulations. Arthritis Rheum. 2003 Nov;48(11):3004-8. doi: 10.1002/art.11332. No abstract available.