Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Antiphospholipid Syndrome Clinical Trial

— APSCORE  

Official title:

Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076713
• Other study ID #: NIAMS-099
• Secondary ID: N01AR02248-000
• Status: Completed
• Phase: N/A
• First received: February 2, 2004
• Last updated: February 11, 2013
• Start date: April 2000
• Est. completion date: April 2007

Study information

• Verified date: February 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Antiphospholipid antibodies with or without associated clinical manifestations

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Hospital for Special Surgery, Weill-Cornell University Medical Center	New York	New York
United States	University of Utah Health Science Center	Salt Lake City	Utah
United States	University of Texas Health Science Center	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Roubey RA. New approaches to prevention of thrombosis in the antiphospholipid syndrome: hopes, trials, and tribulations. Arthritis Rheum. 2003 Nov;48(11):3004-8. Review. — View Citation

External Links

•   Click here for the APSCORE Web site.