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Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03813017
Recruitment Status : Unknown
Verified July 2019 by Osamah Hussein, Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Osamah Hussein, Ziv Hospital

Study Description
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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
Cardiovascular Diseases Rheumatoid Arthritis Atherosclerosis, Coronary

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular disease risks in patient with theumatoid arthritis [ Time Frame: 6 months ]
    Prediction of cardiovascular risks and proposed preventive treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A, on 100 patients with rheumatoid artheritis
Criteria

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
  3. Signed informed consent form
  4. Documented diagnosis of rheumatoid arthritis

Exclusion Criteria:

  1. Known CVD
  2. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813017


Contacts
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Contact: Naaem Simaan, Dr +972523675305 naaem.s@ziv.health.gov.il
Contact: Karine Beiruti, PhD +972528082424 karine.b@ziv.health.gov.il

Sponsors and Collaborators
Ziv Hospital
More Information
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Additional Information:

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Responsible Party: Osamah Hussein, Head of Internal Medicine A, Ziv Hospital
ClinicalTrials.gov Identifier: NCT03813017    
Other Study ID Numbers: 0123-18-ZIV
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Heart Diseases