OsteoarthritisNCT02167906
Impact of Hand Osteoarthritis on Arterial Stiffness
A study testing arterial stiffness measurement in people with Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- arterial stiffness measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2014to 16 Oct 2019
- Phase
- Interventional
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical hand OA defined according to the ACR (American College of Rheumatology) criteria.
- Patients with radiographic hand OA defined according to the Kellgren
- Lawrence criteria (≥ 2).
- Steady dose of statins for at least one month.
- Subject affiliated to a social security scheme
- Written informed consent
Who cannot join
- Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.
- History of arterial hypertension treated and / or uncontrolled (SBP > 140 mmHg and DBP (diastolic blood pressure) > 90 mmHg)
- Diabetes (fasting blood glucose > 7 mmol/L)
- Obesity (BMI > 35 kg/m²)
- Chronic renal failure defined by a glomerular filtration rate <60 ml/min/1,73m ².
- Patient with uncontrolled cardiovascular disease or a personal history of cardiovascular events (myocardial infarction and angina, occlusive arterial disease, stroke)
- Pregnant or breastfeeding, or premenopausal and not taking an effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.
- Conditions
- Osteoarthritis
- Being tested
- arterial stiffness measurement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial stiffness measurementOther
| Study group | Role | What they receive |
|---|---|---|
| hand oa patients | Experimental | assess the carotid-femoral arterial stiffness determined by measuring the PWV Receives: Other: arterial stiffness measurement |
| without Hand OA patients | Active comparator | assess the carotid-femoral arterial stiffness determined by measuring the PWV Receives: Other: arterial stiffness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid-femoral arterial stiffness
To assess the carotid-femoral arterial stiffness determined by measuring the PWV in patients with hand OA compared to healthy subjects.
Measured: within the first 15 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start1 Sep 2014
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167906
- Sponsor's protocol ID
- 9356
- Status last verified
- Jun 2014
- First submitted
- 17 Jun 2014
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hand Osteoarthritis on Arterial Stiffness
- ClinicalTrials.gov ID
- NCT02167906
- Acronym / sponsor ID
- 9356
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 19 Jun 2014 (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 affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hand oa patients | Experimental | Other: arterial stiffness measurementassess the carotid-femoral arterial stiffness determined by measuring the PWV |
| without Hand OA patients | Active comparator | Other: arterial stiffness measurementassess the carotid-femoral arterial stiffness determined by measuring the PWV |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with clinical hand OA defined according to the ACR (American College of Rheumatology) criteria.
- Patients with radiographic hand OA defined according to the Kellgren
- Lawrence criteria (≥ 2).
- Steady dose of statins for at least one month.
- Subject affiliated to a social security scheme
Key exclusion criteria (7 listed)
- Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.
- History of arterial hypertension treated and / or uncontrolled (SBP > 140 mmHg and DBP (diastolic blood pressure) > 90 mmHg)
- Diabetes (fasting blood glucose > 7 mmol/L)
- Obesity (BMI > 35 kg/m²)
- Chronic renal failure defined by a glomerular filtration rate <60 ml/min/1,73m ².
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arterial stiffness measurement | Other | hand oa patients, without Hand OA patients |
Primary outcome
carotid-femoral arterial stiffness
Time frame: within the first 15 days after inclusion
To assess the carotid-femoral arterial stiffness determined by measuring the PWV in patients with hand OA compared to healthy subjects.
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 14 Dec 2022.
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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?
A study testing arterial stiffness measurement in people with Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 7 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 14 Dec 2022. 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 France. 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?
carotid-femoral arterial stiffness (time frame: within the first 15 days after inclusion). 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 Dec 2022.