Antiphospholipid SyndromeURICNCT01818505
The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
An observational study of Antiphospholipid Syndrome and Endothelial Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Antiphospholipid Syndrome, Endothelial Dysfunction, Hyperuricemia
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population
Who may be able to join
- Patient with gouty arthritis
- Patient with asymptomatic hyperurecemia
- Patient of osteoarthritis but without hyperuricemia and gout
Who cannot join
- 1.Patient younger than 20 y/o.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yun-Lin Branch
Dou-Liou City, Yun-Lin County, 640
Yu-Minn Kuo, MD, 8655323911 ext. 5826, 543goole@gmail.com
About this study
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.
Read the 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：
- Patients with gout
- Patients with asymptomatic hyperuricemia
- Patients of osteoarthritis but without hyperuricemia and gout Exclusion Criteria： Patients younger than 20 years old
- Conditions
- Antiphospholipid Syndrome, Endothelial Dysfunction, Hyperuricemia, Gout, Metabolic Syndrome
- Keywords
- antiphospholipid syndrome, gouty arthritis, Hyperuricemia, metabolic syndrome, osteoarthritis, cardiovascular co-morbidities
- Medical subject headings
- Antiphospholipid Syndrome, Hyperuricemia, Gout, Metabolic Syndrome, Arthritis, Gouty, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gouty arthritis | Patient with gouty arthritis | |
| Asymptomatic hyperuricemia | Patient with asymptomatic hyperuricemia | |
| OA without hyperuricemia | Patient of osteoarthritis but without hyperuricemia and gout |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of metabolic syndrome or cardiovascular events
Measured: 36 months
Secondary outcomes (1)
Acute myocardial infarct or stroke
Measured: 36 months or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Min Kuo, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818505
- Sponsor's protocol ID
- URIC
- Acronym
- URIC
- Status last verified
- Apr 2014
- First submitted
- 21 Mar 2013
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01818505
- Acronym / sponsor ID
- URIC / URIC
- Conditions
- Antiphospholipid Syndrome, Endothelial Dysfunction, Hyperuricemia, Gout, Metabolic Syndrome
- Keywords
- antiphospholipid syndrome, gouty arthritis, Hyperuricemia, metabolic syndrome, osteoarthritis, cardiovascular co-morbidities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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：
- Patients with gout
- Patients with asymptomatic hyperuricemia
- Patients of osteoarthritis but without hyperuricemia and gout Exclusion Criteria： Patients younger than 20 years old
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gouty arthritis | – | –Patient with gouty arthritis |
| Asymptomatic hyperuricemia | – | –Patient with asymptomatic hyperuricemia |
| OA without hyperuricemia | – | –Patient of osteoarthritis but without hyperuricemia and gout |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (3 listed)
- Patient with gouty arthritis
- Patient with asymptomatic hyperurecemia
- Patient of osteoarthritis but without hyperuricemia and gout
Key exclusion criteria (1 listed)
- 1.Patient younger than 20 y/o.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
development of metabolic syndrome or cardiovascular events
Time frame: 36 months
1 secondary outcome
Acute myocardial infarct or stroke
Time frame: 36 months or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Min Kuo, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and Endothelial Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Min Kuo, M.D. (886972655701, 543goole@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of metabolic syndrome or cardiovascular events (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.