Antiphospholipid Syndrome Collaborative Registry (APSCORE)

This study has been completed.

Sponsor:

Collaborators:

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

National Center on Minority Health and Health Disparities (NCMHD)

Information provided by (Responsible Party):

Robert Roubey, MD, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00076713

First received: February 2, 2004

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 2, 2004
Last Updated Date	February 11, 2013
Start Date ^ICMJE	April 2000
Primary Completion Date	April 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00076713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Antiphospholipid Syndrome Collaborative Registry (APSCORE)
Official Title ^ICMJE	Antiphospholipid Syndrome Collaborative Registry (APSCORE)
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Serum, plasma, genomic DNA
Sampling Method	Non-Probability Sample
Study Population	Specialty and subspecialty clinics
Condition ^ICMJE	Antiphospholipid Syndrome
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	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. No abstract available.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	860
Completion Date	April 2007
Primary Completion Date	April 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Antiphospholipid antibodies with or without associated clinical manifestations
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00076713
Other Study ID Numbers ^ICMJE	NIAMS-099, N01AR002248-000
Has Data Monitoring Committee	No
Responsible Party	Robert Roubey, MD, University of North Carolina, Chapel Hill
Study Sponsor ^ICMJE	University of North Carolina, Chapel Hill
Collaborators ^ICMJE	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Center on Minority Health and Health Disparities (NCMHD)
Investigators ^ICMJE	Not Provided
Information Provided By	University of North Carolina, Chapel Hill
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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