Rheumatoid ArthritiscLDL in RANCT01105715
Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Cardiovascular Disease, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Cardiovascular Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2013
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from the UAMS Rheumatology Clinic at the UAMS Outpatient Center, Little Rock, other UAMS outpatient clinics, or through advertisement at the UAMS campus and/or the community.
Who may be able to join
- For Cases:
- Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA
- Have currently active disease as assessed by Clinical Disease Activity Index (CDAI)score (a validated composite RA activity index) of > 10
- Have ≥ 3 swollen joints
- For Controls:
- Control subjects will be age, sex, and 5-year age categories matched to cases
- No historical diagnosis of RA and other primary autoimmune or inflammatory disorders
Who cannot join
- For both cases and controls:
- Renal failure (estimated GFR < 60 ml/min) documented within 3 months of study enrollment (from either subject's self-report or review of available medical records)
- Known clinical history of CVD
- Current cancer (other than skin)
- Current or recent (within past 2 weeks) infection
- Individuals taking lipid-lowering medications
- Any other condition the PI staff feels will jeopardize the health and welfare of the participants
- Rheumatoid vasculitis (for cases only)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
The investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation and destruction of joints). Specifically, the study plans to determine whether a particular type of change in proteins in LDL cholesterol ("bad cholesterol") known as carbamylation is an important risk factor for cardiovascular diseases in RA patients. The study will utilize a case-control study design. A total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age and sex matched controls) complete the study. Procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.
- Conditions
- Rheumatoid Arthritis, Cardiovascular Disease
- Keywords
- Rheumatoid Arthritis, cLDL, Cardiovascular disease
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases
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 |
|---|---|---|
| Rheumatoid Arthritis (RA) Case Subjects | * Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA * Have currently active disease as assessed by Clinical Disease Activity Index (CDAI) score of >10 * Have > or = 3 swollen joints | |
| Control Subjects | * Age, sex, and 5-year age categories matched to cases * No historical diagnosis of RA and other primary autoimmune or inflammatory disorders |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105715
- Sponsor's protocol ID
- UAMS 112170
- Acronym
- cLDL in RA
- Status last verified
- Jun 2013
- First submitted
- 15 Apr 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01105715
- Acronym / sponsor ID
- cLDL in RA / UAMS 112170
- Conditions
- Rheumatoid Arthritis, Cardiovascular Disease
- Keywords
- Rheumatoid Arthritis, cLDL, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Apr 2010 (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.
The investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation and destruction of joints). Specifically, the study plans to determine whether a particular type of change in proteins in LDL cholesterol ("bad cholesterol") known as carbamylation is an important risk factor for cardiovascular diseases in RA patients. The study will utilize a case-control study design. A total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age and sex matched controls) complete the study. Procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis (RA) Case Subjects | – | –* Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA * Have currently active disease as assessed by Clinical Disease Activity Index (CDAI) score of >10 * Have > or = 3 swollen joints |
| Control Subjects | – | –* Age, sex, and 5-year age categories matched to cases * No historical diagnosis of RA and other primary autoimmune or inflammatory disorders |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the UAMS Rheumatology Clinic at the UAMS Outpatient Center, Little Rock, other UAMS outpatient clinics, or through advertisement at the UAMS campus and/or the community.
Key inclusion criteria (7 listed)
- Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA
- Have currently active disease as assessed by Clinical Disease Activity Index (CDAI)score (a validated composite RA activity index) of > 10
- Have ≥ 3 swollen joints
- Control subjects will be age, sex, and 5-year age categories matched to cases
- No historical diagnosis of RA and other primary autoimmune or inflammatory disorders
Key exclusion criteria (8 listed)
- Renal failure (estimated GFR < 60 ml/min) documented within 3 months of study enrollment (from either subject's self-report or review of available medical records)
- Known clinical history of CVD
- Current cancer (other than skin)
- Current or recent (within past 2 weeks) infection
- Individuals taking lipid-lowering medications
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatoid Arthritis and Cardiovascular Disease, run by University of Arkansas at 1 site in United States.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 19 Jun 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 19 Jun 2013.