Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Cardiovascular Diseases Clinical Trial

Official title:

Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03813017
• Other study ID #: 0123-18-ZIV
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: July 2020

Study information

• Verified date: July 2019
• Source: Ziv Hospital
• Contact: Naaem Simaan, Dr
• Phone: +972523675305
• Email: naaem.s[@]ziv.health.gov.il
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Atherosclerosis
• Atherosclerosis, Coronary
• Cardiovascular Diseases
• Coronary Artery Disease
• Myocardial Ischemia
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease risks in patient with theumatoid arthritis	Prediction of cardiovascular risks and proposed preventive treatment	6 months