NCT06738264

Brief 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 ?

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 Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

December 12, 2024

Last Update Submit

December 12, 2024

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • carotid artery wall thickness

    abnormality in carotid doppler

    one week

Study Arms (2)

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

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

rheumatology outpatient clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

amna mohamed ameen

CONTACT

01010283972amnaameen992@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

January 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12