Impact of Hand Osteoarthritis on Arterial Stiffness

NCT02167906 | Completed

• 1 other identifier: 9356
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  within the first 15 days after inclusion

Study Arms (2)

hand oa patients

EXPERIMENTAL

assess the carotid-femoral arterial stiffness determined by measuring the PWV

Other: arterial stiffness measurement

without Hand OA patients

ACTIVE COMPARATOR

assess the carotid-femoral arterial stiffness determined by measuring the PWV

Other: arterial stiffness measurement

Interventions

arterial stiffness measurement OTHER

hand oa patients; without Hand OA patients

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34 295, France

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: September 1, 2014
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: December 14, 2022

Record last verified: 2014-06

Locations

FR (1)