Skip to main content
OpenTrials
Completed

NCT Number: NCT02167906

Impact of Hand Osteoarthritis on Arterial Stiffness

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, 34 295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial Stiffness Measurement

Other

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2014
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.