Rheumatoid ArthritisNCT00990730
Atherosclerosis in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Endothelial Dysfunction, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to investigate the link between rheumatoid arthritis and cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities, and endothelial function. 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, Endothelial Dysfunction
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2011
- 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: RA subjects are from the UCSF RA cohort based at San Francisco General Hospital and UCSF Medical Center. Controls will be selected from primary care clinics from these hospitals
Who may be able to join
- Diagnosis of RA by ACR criteria
- Age 18-80
- Enrolled in UCSF RA cohort already
Who cannot join
- Diabetes (on meds or in medical history)
- Pregnant or Lactating
- Renal failure (Creatinine > 2mg/dL or on dialysis)
- History of MI or CAD
- History of ischemic CVA
- Symptomatic PVD
Show all 12Show fewer
- Current uncontrolled hypertension (blood pressure > 160/100mmHg)
- Daily prednisone > 10mg daily
- Current smoker
- New BP med within 3 months
- New statin within 3 months
- Change in RA meds: new or increase in prednisone within 1 month, new TNF inhibitor within 2 months, titration of methotrexate, leflunomide or sulfasalazine within 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF San Francisco General Hospital Vascular Research Center
San Francisco, California, 94110
About this study
Official title: Atherosclerosis in Rheumatoid Arthritis: Role of Inflammation, Lipoproteins, and Endothelial Dysfunction
The purpose of this study is to investigate the link between rheumatoid arthritis and cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities, and endothelial function.
Read the detailed description
In the general population, individuals with elevated inflammatory markers (e.g. C-reactive protein, CRP) have increased cardiovascular disease. Patients with RA have chronic elevations in CRP and other inflammatory markers that are usually higher than the levels associated with increased cardiovascular risk in the general population. Indeed, RA patients have accelerated disease of their blood vessels, and increased cardiovascular death not explained by traditional cardiac risk factors but associated with chronic inflammation. However, the mechanisms by which inflammation leads to cardiovascular disease are not well characterized in RA. Moreover, current treatment strategies of RA largely target joint symptoms rather than inflammation, potentially leaving patients at increased risk for cardiovascular disease. Studies of markers that increase the risk of heart disease in the full spectrum of RA are missing. We hypothesize that inflammatory markers will be more strongly associated with abnormalities in blood vessels in RA patients than any clinical measure of disease activity. This hypothesis will be tested with a cross-sectional study of patients in the UCSF RA cohort. Aim 1 will characterize abnormal blood vessel changes across the spectrum of RA disease activity, specifically measuring ultrasound of the upper arm artery, markers of oxidative stress, and abnormalities in cholesterol proteins. Aim 2 will identify factors associated with these changes across the spectrum of RA disease activity, specifically focusing on the association between inflammatory markers, cholesterol, and blood vessel abnormalities.
- Conditions
- Rheumatoid Arthritis, Endothelial Dysfunction
- Keywords
- rheumatoid arthritis, endothelial dysfunction, lipoproteins, inflammation, oxidative stress, arterial stiffness
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
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 subjects | 60 subjects with rheumatoid arthritis, defined by American College of Rheumatology Criteria, enrolled in the UCSF RA cohort | |
| healthy controls | 20 matched controls without rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow mediated vasodilation of the brachial artery, measured by ultrasound
Measured: 1 day
Secondary outcomes (3)
pulse wave velocity/arterial stiffness
Measured: day 1
lipid metabolism
Measured: day 1
pulse ampitude
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
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 California, San FranciscoThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Priscilla Hsue, University of California, San Francisco
- Investigators
- Priscilla Y Hsue, MD, Principal investigator, University of California, San FranciscoPeter Ganz, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990730
- Sponsor's protocol ID
- H11397-34652-01
- Other IDs
- F32HL097461-01, SFGH GCRC 6128
- Status last verified
- Jan 2012
- First submitted
- 2 Oct 2009
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis in Rheumatoid Arthritis: Role of Inflammation, Lipoproteins, and Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT00990730
- Acronym / sponsor ID
- H11397-34652-01
- Conditions
- Rheumatoid Arthritis, Endothelial Dysfunction
- Keywords
- rheumatoid arthritis, endothelial dysfunction, lipoproteins, inflammation, oxidative stress, arterial stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Oct 2009 (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 purpose of this study is to investigate the link between rheumatoid arthritis and cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities, and endothelial function.
Detailed description
In the general population, individuals with elevated inflammatory markers (e.g. C-reactive protein, CRP) have increased cardiovascular disease. Patients with RA have chronic elevations in CRP and other inflammatory markers that are usually higher than the levels associated with increased cardiovascular risk in the general population. Indeed, RA patients have accelerated disease of their blood vessels, and increased cardiovascular death not explained by traditional cardiac risk factors but associated with chronic inflammation. However, the mechanisms by which inflammation leads to cardiovascular disease are not well characterized in RA. Moreover, current treatment strategies of RA largely target joint symptoms rather than inflammation, potentially leaving patients at increased risk for cardiovascular disease. Studies of markers that increase the risk of heart disease in the full spectrum of RA are missing. We hypothesize that inflammatory markers will be more strongly associated with abnormalities in blood vessels in RA patients than any clinical measure of disease activity. This hypothesis will be tested with a cross-sectional study of patients in the UCSF RA cohort. Aim 1 will characterize abnormal blood vessel changes across the spectrum of RA disease activity, specifically measuring ultrasound of the upper arm artery, markers of oxidative stress, and abnormalities in cholesterol proteins. Aim 2 will identify factors associated with these changes across the spectrum of RA disease activity, specifically focusing on the association between inflammatory markers, cholesterol, and blood vessel abnormalities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis subjects | – | –60 subjects with rheumatoid arthritis, defined by American College of Rheumatology Criteria, enrolled in the UCSF RA cohort |
| healthy controls | – | –20 matched controls without rheumatoid arthritis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- RA subjects are from the UCSF RA cohort based at San Francisco General Hospital and UCSF Medical Center. Controls will be selected from primary care clinics from these hospitals
Key inclusion criteria (3 listed)
- Diagnosis of RA by ACR criteria
- Age 18-80
- Enrolled in UCSF RA cohort already
Key exclusion criteria (12 listed)
- Diabetes (on meds or in medical history)
- Pregnant or Lactating
- Renal failure (Creatinine > 2mg/dL or on dialysis)
- History of MI or CAD
- History of ischemic CVA
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
flow mediated vasodilation of the brachial artery, measured by ultrasound
Time frame: 1 day
3 secondary outcomes
pulse wave velocity/arterial stiffness
Time frame: day 1
lipid metabolism
Time frame: day 1
pulse ampitude
Time frame: 1 day
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 25 Jan 2012.
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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.
Priscilla Y Hsue, MD principal investigator
University of California, San Francisco
Peter Ganz, MD study director
University of California, San Francisco
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 Endothelial Dysfunction, run by University of California, San Francisco 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 3 inclusion and 12 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 25 Jan 2012. 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.
What does the primary outcome measure?
flow mediated vasodilation of the brachial artery, measured by ultrasound (time frame: 1 day). 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 25 Jan 2012; AzTrials last refreshed its copy on 2 Nov 2026.