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

NCT ID: NCT06227442

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-03-01

Brief Summary

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

Detailed Description

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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 .

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

will include 48 RA patients without renal affection.

KDIGO criteria of 2010

Intervention Type 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 B

will include 48 RA patients with renal affection.

KDIGO criteria of 2010

Intervention Type 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 C

will include 48 healthy control.

KDIGO criteria of 2010

Intervention Type 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.

Interventions

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KDIGO criteria of 2010

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Noman Mohamed AbdElaziz

master

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 28978936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34397890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33204418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17045630 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2189161 (View on PubMed)

Other Identifiers

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PORIIRA

Identifier Type: -

Identifier Source: org_study_id

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