跳至主要内容
临床试验/NCT06738264
NCT06738264尚未招募不适用

Cardiovascular Risk Factors in Rheumatoid Arthritis Patients ( Comparison Between Seronegative and Seropositive Cases )

Sohag University0 个研究点目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
carotid artery wall thickness

研究概览

简要总结

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 ?

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

carotid artery wall thickness

时间窗: one week

abnormality in carotid doppler

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amna Mohamed Mahmoud

resident doctor

Sohag University

相似试验