Cardiovascular DiseasesNCT03813017
Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
An observational study of Cardiovascular Diseases and Rheumatoid Arthritis, run by Ziv Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Rheumatoid Arthritis, Atherosclerosis, Coronary
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Jul 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A, on 100 patients with rheumatoid artheritis
Who may be able to join
- 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
Show all 9Show fewer
- CAS /intervention
- Signed informed consent form
- Documented diagnosis of rheumatoid arthritis
Who cannot join
- Known CVD
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Medical subject headings
- Cardiovascular Diseases, Arthritis, Rheumatoid, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease risks in patient with theumatoid arthritis
Prediction of cardiovascular risks and proposed preventive treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startOct 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osamah Hussein, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813017
- Sponsor's protocol ID
- 0123-18-ZIV
- Status last verified
- Jul 2019
- First submitted
- 13 Jan 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03813017
- Acronym / sponsor ID
- 0123-18-ZIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A, on 100 patients with rheumatoid artheritis
Key inclusion criteria (9 listed)
- 18-70 years old (except for women till 75 years old)
- Absence of established CVD:
- Signed informed consent form
- Documented diagnosis of rheumatoid arthritis
Key exclusion criteria (2 listed)
- Known CVD
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular disease risks in patient with theumatoid arthritis
Time frame: 6 months
Prediction of cardiovascular risks and proposed preventive treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Rheumatoid Arthritis, run by Ziv Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naaem Simaan, Dr (+972523675305, naaem.s@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease risks in patient with theumatoid arthritis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.