Renal Resistive Index as a Predictor of Renal Involvement in Rheumatoid Arthritis

Not yet recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Diagnostic Test: KDIGO criteria of 2010

• Registration Number: NCT06227442
• Lead Sponsor: Assiut University

Brief Summary

Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis.

Detailed Description

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by synovial hyperplasia and inflammation, progressive joint destruction, and significant disability (1). It can occur at any age, but it predominantly affects women, with a peak onset between the ages of 40 and 60. RA etiology is not yet clear, Recent studies have shown that its mechanism is closely related to genetics, environment, and immune response. Genes such as MHC and HLA-DR4 are involved in the occurrence of RA. (2) Renal complications in RA can range from mild abnormalities in kidney function to more severe conditions, such as glomerulonephritis and renal amyloidosis. Understanding these renal complications is crucial for healthcare providers to ensure comprehensive care for RA patients. (3.4) Vasculitis is an uncommon complication of RA (in approximately 2 to 5% of patients), males with RA are more likely (2 to 4 times more likely) than females with RA to develop RV. Rheumatoid vasculitis most often occur in people with at least 10 years of severe disease. Fortunately, recent reports have noted declines in the prevalence of RV ( 5.6). So The renal arterial resistive index (RI)which is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70. Elevated values are associated with poorer prognosis in various renal disorders .

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Study Start: 2024-02-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Patients of rheumatoid arthritis è renal affection
• Patients of rheumatoid arthritis without renal affection
• Patients of rheumatoid arthritis on drugs (NSAIDs, DMARDS, methotrexate..).

Exclusion Criteria

• Diabetic and hypertensive patients, patients with hepatitis B, C viruses or liver cell failure, patients with acute kidney injury, patients with another autoimmune disease as (SLE, sjogren disease, multiple sclerosis, patients with malignancy, patients on another drugs otherwise rheumatoid arthritis drugs).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	KDIGO criteria of 2010	will include 48 RA patients without renal affection.
Group C	KDIGO criteria of 2010	will include 48 healthy control.
Group B	KDIGO criteria of 2010	will include 48 RA patients with renal affection.

Primary Outcome Measures

Name	Time	Method
Evaluating predictive value of renal resistive index in detection of rheumatoid arthritis.	baseline	Assesses the predictive utility of renal resistive index in detecting rheumatoid arthritis. Delve into the exploration of whether renal resistive index serves as a reliable marker, offering valuable insights into the potential diagnostic relevance for rheumatoid arthritis.

Secondary Outcome Measures

Name	Time	Method
Identify the risk factor for renal complication in RA patients	baseline	Explore the factors contributing to renal complications in rheumatoid arthritis (RA) patients with a focus on identifying key risk factors. Uncover insights that enhance our understanding of the complex relationship between RA and renal involvement, ultimately aiding in targeted prevention and management strategies.