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

NCT06227442 | Unknown

• 1 other identifier: PORIIRA
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Evaluating predictive value of renal resistive index in detection of rheumatoid arthritis.

  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.

  baseline

Secondary Outcomes (1)

• Identify the risk factor for renal complication in RA patients

  baseline

Study Arms (3)

Group A

will include 48 RA patients without renal affection.

Diagnostic Test: KDIGO criteria of 2010

Group B

will include 48 RA patients with renal affection.

Diagnostic Test: KDIGO criteria of 2010

Group C

will include 48 healthy control.

Diagnostic Test: KDIGO criteria of 2010

Interventions

KDIGO criteria of 2010 DIAGNOSTIC_TEST

They are guidelines for the diagnosis, evaluation, and management of chronic kidney disease (CKD). They cover the classification of CKD stages based on glomerular filtration rate and albuminuria, criteria for diagnosing acute kidney injury, and recommendations for managing CKD-related complications.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Base on determining the main outcome variable, the estimated minimum required sample size is 144 cases (48 case in each group) The sample size was calculated using G\*power software 3.1.9.7 based on following assumptions: Mean serum creatinine level in RA patients without renal affection compared to mean serum creatinine level RA patients with renal affection and control group. The Effect size is estimated to be 0.3. Main statistical test is one way ANOVA ,Alpha=0.05, power=90

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Li XF, Sun YY, Bao J, Chen X, Li YH, Yang Y, Zhang L, Huang C, Wu BM, Meng XM, Li J. Functional role of PPAR-gamma on the proliferation and migration of fibroblast-like synoviocytes in rheumatoid arthritis. Sci Rep. 2017 Oct 4;7(1):12671. doi: 10.1038/s41598-017-12570-6.

  PMID: 28978936 BACKGROUND

• Jung JY, Kim YB, Kim JW, Suh CH, Kim HA. Biologic therapy for amyloid A amyloidosis secondary to rheumatoid arthritis treated with interleukin 6 therapy: Case report and review of literature. Medicine (Baltimore). 2021 Aug 13;100(32):e26843. doi: 10.1097/MD.0000000000026843.

  PMID: 34397890 BACKGROUND

• Oweis AO, Alawneh KM, Alshelleh SA, Alnaimat F, Alawneh D, Zahran DJ. Renal dysfunction among rheumatoid arthritis patients: A retrospective cohort study. Ann Med Surg (Lond). 2020 Nov 4;60:280-284. doi: 10.1016/j.amsu.2020.11.011. eCollection 2020 Dec.

  PMID: 33204418 BACKGROUND

• Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006 Dec;36(3):182-8. doi: 10.1016/j.semarthrit.2006.08.006. Epub 2006 Oct 11.

  PMID: 17045630 BACKGROUND

• Vollertsen RS, Conn DL. Vasculitis associated with rheumatoid arthritis. Rheum Dis Clin North Am. 1990 May;16(2):445-61.

  PMID: 2189161 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01