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Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Sponsor
Ziv Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03813017
Collaborator
(none)
100
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Cardiovascular disease is a leading cause for morbidity and mortality in general population. The incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of incident CVD is increased by 48% in patients with RA compared to the general population.

RA is associated with 50% increase in the mortality in patients with cardiovascular disease (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared with the general population. Patients with RA have a high risk of premature cardiovascular disease (CVD). The aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in RA patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
    Anticipated Study Start Date :
    Oct 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular disease risks in patient with theumatoid arthritis [6 months]

      Prediction of cardiovascular risks and proposed preventive treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 18-70 years old (except for women till 75 years old)

    2. Absence of established CVD:

    • Myocardial Infarction p/h

    • PCI with balloon and/or stent

    • Intermittent claudication

    • PAD / intervention

    • CAS /intervention

    1. Signed informed consent form

    2. Documented diagnosis of rheumatoid arthritis

    Exclusion Criteria:

    1. Known CVD

    2. Pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ziv Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osamah Hussein, Head of Internal Medicine A, Ziv Hospital
    ClinicalTrials.gov Identifier:
    NCT03813017
    Other Study ID Numbers:
    • 0123-18-ZIV
    First Posted:
    Jan 23, 2019
    Last Update Posted:
    Jul 10, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Cardiovascular Diseases
    Atherosclerosis
    Coronary Artery Disease
    Myocardial Ischemia

    Study Results

    No Results Posted as of Jul 10, 2019