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Impact of Hand Osteoarthritis on Arterial Stiffness

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
arterial stiffness measurement
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoarthritis

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hand oa patients

without Hand OA patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2014
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02167906
Brief Title
Impact of Hand Osteoarthritis on Arterial Stiffness
Official Title
Impact of Hand Osteoarthritis on Arterial Stiffness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hand oa patients
Arm Type
Experimental
Arm Description
assess the carotid-femoral arterial stiffness determined by measuring the PWV
Arm Title
without Hand OA patients
Arm Type
Active Comparator
Arm Description
assess the carotid-femoral arterial stiffness determined by measuring the PWV
Intervention Type
Other
Intervention Name(s)
arterial stiffness measurement
Primary Outcome Measure Information:
Title
carotid-femoral arterial stiffness
Description
To assess the carotid-femoral arterial stiffness determined by measuring the PWV in patients with hand OA compared to healthy subjects.
Time Frame
within the first 15 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34 295
Country
France

12. IPD Sharing Statement

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Impact of Hand Osteoarthritis on Arterial Stiffness

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