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The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome (URIC)

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ClinicalTrials.gov Identifier: NCT01818505
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 26, 2013
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date March 21, 2013
First Posted Date March 26, 2013
Last Update Posted Date April 14, 2014
Study Start Date March 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2013)
development of metabolic syndrome or cardiovascular events [ Time Frame: 36 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01818505 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 25, 2013)
Acute myocardial infarct or stroke [ Time Frame: 36 months or more ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
Official Title The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
Brief Summary Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, the investigators will analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. The investigators expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.
Detailed Description

Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, we'll analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/ asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. We expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.

Patient eligibility:

  1. Patients with gout
  2. Patients with asymptomatic hyperuricemia
  3. Patients of osteoarthritis but without hyperuricemia and gout Exclusion Criteria: Patients younger than 20 years old
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum
Sampling Method Non-Probability Sample
Study Population General population
Condition
  • Antiphospholipid Syndrome
  • Endothelial Dysfunction
  • Hyperuricemia
  • Gout
  • Metabolic Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • Gouty arthritis
    Patient with gouty arthritis
  • Asymptomatic hyperuricemia
    Patient with asymptomatic hyperuricemia
  • OA without hyperuricemia
    Patient of osteoarthritis but without hyperuricemia and gout
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 25, 2013)
210
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient with gouty arthritis
  2. Patient with asymptomatic hyperurecemia
  3. Patient of osteoarthritis but without hyperuricemia and gout

Exclusion Criteria:

1.Patient younger than 20 y/o.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01818505
Other Study ID Numbers URIC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yu-Min Kuo, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date April 2014