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Impact of Hand Osteoarthritis on Arterial Stiffness

NCT ID: NCT02167906

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2019-10-16

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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hand oa patients

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

Group Type EXPERIMENTAL

arterial stiffness measurement

Intervention Type OTHER

without Hand OA patients

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

Group Type ACTIVE_COMPARATOR

arterial stiffness measurement

Intervention Type OTHER

Interventions

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arterial stiffness measurement

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9356

Identifier Type: -

Identifier Source: org_study_id