Rheumatoid ArthritisNCT06738264
Cardiovascular Risk Factors in Rheumatoid Arthritis Patients ( Comparison Between Seronegative and Seropositive Cases )
An observational study of Rheumatoid Arthritis, run by Sohag University.
Trial summary
The goal of this observational study is to learn about the long-term effects rheumatoid arthritis (RA) on cardiovascular system. The main question it aims to answer is: Does seropositive raise risk of cardiovascular diseases more than seronegative RA ? Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: rheumatology outpatient clinic
Who may be able to join
- Adult patients ≥ 18 years.
- Both sexes.
- All patients with RA confirmed using the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology EULAR classification criteria
- RA diagnosed for at least six months to ensure chronicity.
Who cannot join
- Diagnosis of other significant autoimmune diseases (e.g., lupus, scleroderma).
- Use of medications known to significantly affect cardiovascular outcomes (e.g., certain anticoagulants or anti-inflammatory agents) that are not part of standard RA treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn about the long-term effects rheumatoid arthritis (RA) on cardiovascular system. The main question it aims to answer is:
Does seropositive raise risk of cardiovascular diseases more than seronegative RA ?
Read the detailed description
We will investigate cardiovascular risk factors in patients with seronegative and seropositive rheumatoid arthritis.
Complete clinical examination including blood pressure (BP; using an automatic BP monitor) and heart rate (in beats per minute (bpm) either from an automatic BP monitor or a 12 lead ECG) will be measured according to the standard hospital procedures.
Routine Laboratory investigations, including complete blood count (CBC), Blood parameters, including autoantibodies and lipid profile will be determined), liver and kidney function tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and lipid profile panel will be recorded.
The disease activity score-28 (DAS-28) and health assessment questionnaire (HAQ) will be assessed.
Framingham risk score will be calculated. Carotid doppler will be done . Current medications use including synthetic disease-modifying anti-rheumatic drugs (DMARDs), in addition to steroids, will be recorded.
Rheumatoid Factor and Anticitrullinated proteins antibodies presence will be determined.
Cardiovascular risk factors, including inflammation, hypertension, smoking, obesity, and dyslipidemia will be observed and a higher risk of Cardiovascular Diseases events (including myocardial infarction, stroke, and heart failure).
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| seronegative RA | Rheumatoid arthritis patients with negative rheumatoid factor and negative anti citrullinated proteins | |
| seropositive RA | Rheumatoid arthritis patients with positive rheumatoid factor and positive anti citrullinated proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid artery wall thickness
abnormality in carotid doppler
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Mohamed Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738264
- Sponsor's protocol ID
- Soh-Med--24-11-11MS
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Factors in Rheumatoid Arthritis Patients ( Comparison Between Seronegative and Seropositive Cases )
- ClinicalTrials.gov ID
- NCT06738264
- Acronym / sponsor ID
- Soh-Med--24-11-11MS
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 17 Dec 2024 (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.
The goal of this observational study is to learn about the long-term effects rheumatoid arthritis (RA) on cardiovascular system. The main question it aims to answer is:
Does seropositive raise risk of cardiovascular diseases more than seronegative RA ?
Detailed description
We will investigate cardiovascular risk factors in patients with seronegative and seropositive rheumatoid arthritis.
Complete clinical examination including blood pressure (BP; using an automatic BP monitor) and heart rate (in beats per minute (bpm) either from an automatic BP monitor or a 12 lead ECG) will be measured according to the standard hospital procedures.
Routine Laboratory investigations, including complete blood count (CBC), Blood parameters, including autoantibodies and lipid profile will be determined), liver and kidney function tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and lipid profile panel will be recorded.
The disease activity score-28 (DAS-28) and health assessment questionnaire (HAQ) will be assessed.
Framingham risk score will be calculated. Carotid doppler will be done . Current medications use including synthetic disease-modifying anti-rheumatic drugs (DMARDs), in addition to steroids, will be recorded.
Rheumatoid Factor and Anticitrullinated proteins antibodies presence will be determined.
Cardiovascular risk factors, including inflammation, hypertension, smoking, obesity, and dyslipidemia will be observed and a higher risk of Cardiovascular Diseases events (including myocardial infarction, stroke, and heart failure).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| seronegative RA | – | –Rheumatoid arthritis patients with negative rheumatoid factor and negative anti citrullinated proteins |
| seropositive RA | – | –Rheumatoid arthritis patients with positive rheumatoid factor and positive anti citrullinated proteins |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- rheumatology outpatient clinic
Key inclusion criteria (4 listed)
- Adult patients ≥ 18 years.
- Both sexes.
- All patients with RA confirmed using the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology EULAR classification criteria
- RA diagnosed for at least six months to ensure chronicity.
Key exclusion criteria (2 listed)
- Diagnosis of other significant autoimmune diseases (e.g., lupus, scleroderma).
- Use of medications known to significantly affect cardiovascular outcomes (e.g., certain anticoagulants or anti-inflammatory agents) that are not part of standard RA treatment.
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
carotid artery wall thickness
Time frame: one week
abnormality in carotid doppler
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Sohag University.
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 4 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: opening soon, as of the sponsor's last update on 17 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amna mohamed ameen (01010283972, amnaameen992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid artery wall thickness (time frame: one week). 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 17 Dec 2024.