NCT01818505

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2.8 years

First QC Date

March 21, 2013

Last Update Submit

April 11, 2014

Conditions

Keywords

antiphospholipid syndromegouty arthritisHyperuricemiametabolic syndromeosteoarthritiscardiovascular co-morbidities

Outcome Measures

Primary Outcomes (1)

  • development of metabolic syndrome or cardiovascular events

    36 months

Secondary Outcomes (1)

  • Acute myocardial infarct or stroke

    36 months or more

Study Arms (3)

Gouty arthritis

Patient with gouty arthritis

Asymptomatic hyperuricemia

Patient with asymptomatic hyperuricemia

OA without hyperuricemia

Patient of osteoarthritis but without hyperuricemia and gout

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population

You may qualify if:

  • Patient with gouty arthritis
  • Patient with asymptomatic hyperurecemia
  • Patient of osteoarthritis but without hyperuricemia and gout

You may not qualify if:

  • Patient younger than 20 y/o.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Yun-Lin Branch

Dou-Liou City, Yun-Lin County, 640, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Antiphospholipid SyndromeHyperuricemiaGoutMetabolic SyndromeArthritis, GoutyOsteoarthritis

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Yu-Min Kuo, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Min Kuo, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 26, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations