- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813017
Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Naaem Simaan, Dr
- Phone Number: +972523675305
- Email: naaem.s@ziv.health.gov.il
Study Contact Backup
- Name: Karine Beiruti, PhD
- Phone Number: +972528082424
- Email: karine.b@ziv.health.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-70 years old (except for women till 75 years old)
Absence of established CVD:
- Myocardial Infarction p/h
- PCI with balloon and/or stent
- Intermittent claudication
- PAD / intervention
- CAS /intervention
- Signed informed consent form
- Documented diagnosis of rheumatoid arthritis
Exclusion Criteria:
- Known CVD
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular disease risks in patient with theumatoid arthritis
Time Frame: 6 months
|
Prediction of cardiovascular risks and proposed preventive treatment
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Vascular Diseases
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Coronary Disease
- Coronary Artery Disease
- Myocardial Ischemia
- Cardiovascular Diseases
- Arthritis
- Arthritis, Rheumatoid
- Atherosclerosis
Other Study ID Numbers
- 0123-18-ZIV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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