Antiphospholipid Syndrome Collaborative Registry (APSCORE)

NCT ID: NCT00076713

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 860 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2007-04-30

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.

Conditions

Antiphospholipid Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Antiphospholipid antibodies with or without associated clinical manifestations

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Robert Roubey, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Morehouse School of Medicine

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Hospital for Special Surgery, Weill-Cornell University Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Texas Health Science Center

San Antonio, Texas, United States

University of Utah Health Science Center

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14613259 (View on PubMed)

Related Links

http://www.aboutus.org/Apscore.org

Click here for the APSCORE Web site.

Other Identifiers

N01AR002248-000

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-099

Identifier Type: -

Identifier Source: org_study_id