Impact of Hand Osteoarthritis on Arterial Stiffness

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: arterial stiffness measurement

• Registration Number: NCT02167906
• Lead Sponsor: University Hospital, Montpellier

Brief 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 %. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Study Start: 2014-09-01
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hand oa patients	arterial stiffness measurement	assess the carotid-femoral arterial stiffness determined by measuring the PWV
without Hand OA patients	arterial stiffness measurement	assess the carotid-femoral arterial stiffness determined by measuring the PWV

Primary Outcome Measures

Name	Time	Method
carotid-femoral arterial stiffness	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.

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France