NCT03813017

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

January 13, 2019

Last Update Submit

July 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular disease risks in patient with theumatoid arthritis

    Prediction of cardiovascular risks and proposed preventive treatment

    6 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A, on 100 patients with rheumatoid artheritis

You may qualify if:

  • 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

You may not qualify if:

  • Known CVD
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesArthritis, RheumatoidCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Internal Medicine A

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 23, 2019

Study Start

October 1, 2019

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

July 10, 2019

Record last verified: 2019-07