跳至主要内容
临床试验/NCT07188688
NCT07188688尚未招募不适用

Shear-Wave Elastography to Detect Enthesitis in Psoriatic Arthritis: Relationship With SIRT2 Expression and Disease Activity

Assiut University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
57
试验地点
1
主要终点
Assessment and comparting the diagnostic utility of shear-wave elastography (SWE) , Gray-scale (GS) ultrasound. and Power Doppler (PD) in detecting tendinopathy in psoriatic patients with and without arthritis.

研究概览

简要总结

  1. To assess the diagnostic utility of shear-wave elastography (SWE), gray-scale (GS) ultrasound, and Power Doppler (PD) in detecting Patellar and Achilles tendinopathy in psoriatic patients with and without arthritis.
  2. Investigate the relation between SWE, GS ultrasound, and PD finding and SIRT2 expression levels.
  3. Evaluate the association of the imaging findings and SIRT2 levels with psoriatic arthritis disease activity score.

详细描述

Psoriatic arthritis is chronic inflammatory arthritis associated with psoriasis which was found in about 20% of patients with psoriatic arthritis. Psoriatic arthritis (PsA) is associated with decreased quality of life. As delayed diagnosis may lead to progressive joint destruction and long-term disability, the key clinical features of PsA should be recognizable to a wide range of clinicians to facilitate early diagnosis. The transition from psoriasis (PsO) to psoriatic arthritis (PsA) and the early diagnosis of PsA is of considerable scientific and clinical interest for the prevention and interception of PsA. Enthesopathy is the cornerstone of the pathophysiology of psoriatic arthritis (PsA). Even in patients without entheses symptoms, enthesitis has been demonstrated by imaging modalities both at the enthesis of load and the so-called "mini-enthesis" (pseudo-enthesis of the fingers). Moreover, inflammatory enthesopathy has been demonstrated in patients with psoriasis (PsO), and it is presumed that this finding could be, to some extent, a predictor of the development of PsA. Psoriatic arthritis is a complex heterogeneous disease manifesting skin disease and several musculoskeletal abnormalities including arthritis, enthesitis, dactylitis and spondylitis. While not all these manifestations are present in every patient, assessment of disease activity should account for these domains. To combining these domains into one composite score has been challenging but several have been developed as Psoriatic Arthritis Disease Activity Score (PASDAS) and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite scorE (GRACE index). Musculoskeletal ultrasound (MSUS) imaging plays a pivotal role in the diagnosis and management of musculoskeletal disorders. Additionally, MSUS is a non-invasive, radiation-free and cost-effective tool, making it accessible for routine use in clinical practice. MSUS is playing an increasingly important role in optimizing clinical assessment of patients with rheumatic ultrasound conditions and substantially improves therapeutic and diagnostic capabilities. Ultrasound (US) is a reliable modality in detecting a wide range of musculoskeletal inflammatory lesions in PsA. MSUS correlates well with MRI findings and was found to be more reliable than physical examination in the assessment of musculoskeletal abnormalities. In addition, it is an affordable and accessible tool that is widely used in rheumatology practice. Recent advances in US technology hold promise to introduce highly mobile devices that could potentially be used in non-rheumatology settings (e.g., dermatology, primary care), increasing access to this technology. This highlights the potential use of the US as a point-of-care tool for optimizing early diagnosis of PsA at early stages of their disease. Shear-wave elastography (SWE) is a new technique that provides information on the elastic properties of tissues. It generates the quantitative data in kilopascals (kPa) by measuring the propagation velocity distribution of shear waves in tissues produced by a focused acoustic push pulse. It also provides qualitative data as colour coded images; these images are superimposed on a GS ultrasound image. Harder tissues appear red or yellow and softer tissues appear blue or green. Strain elastography and shear wave elastography reported as shear wave velocity have the best potential to be used in the identification of tendinopathy. Further high-quality studies with robust longitudinal designs to investigate responsiveness are needed to aid the monitoring of tendon recovery. The purpose of the study is to compare the accuracy of SWE with conventional ultrasound (GS and PD) for diagnosing patellar and Achilles tendinopathy in patients with psoriasis with and without arthritis and correlate the findings with clinical symptoms and disease severity scores in patients with psoriasis and psoriatic arthritis. Psoriatic arthritis (PsA) is characterized by a heterogeneous clinical phenotype that makes diagnosis and treatment challenging, particularly in the early stages where diagnosis remains difficult. Currently, diagnosis relies predominantly on clinical findings, highlighting the need for reliable biomarkers to improve diagnostic precision, refine prognostic evaluations, and guide personalized therapeutic strategies. Since a diagnostic delay of more than six months may contribute to poor functional and radiographic outcomes, it is critical to identify biomarkers that can facilitate the early diagnosis of PsA and help predict therapeutic responses. Sirtuins (SIRTs; silent information regulators) are an evolutionarily conserved group of enzymes involved in the post-translational modification of proteins including deacetylation, polyADP-ribosylation, demalonylation and lipoamidation. They exist in many cells and in a variety of organisms. Their names are derived from the SIRT2 (silent information regulator 2) gene, first identified in cells of the yeast Saccharomyces cerevisiae. SIRTs are involved in the recombination of ribosomal DNA and participate in gene silencing and DNA repair. SIRTs are involved in several cellular pathways related to ageing, inflammation, oxidative stress, epigenetics, tumorigenesis, the cell cycle, DNA repair and cell proliferation, positioning them as an essential component in the pathogenesis of many diseases, including psoriasis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients diagnosed as PsO by a dermatologist according to PASI score.
  • Patients diagnosed as PsA by rheumatologist according to CASPAR classification criteria for psoriatic arthritis
  • Adult patients of both sexes with an average > 18 years

排除标准

  • Patients with a history of metabolic disease affecting tendons.
  • Patients with history of surgery, injury or trauma of patellar and/or Achilles tendon.
  • Patients with other rheumatological diseases.
  • Patients below 18.

结局指标

主要结局

Assessment and comparting the diagnostic utility of shear-wave elastography (SWE) , Gray-scale (GS) ultrasound. and Power Doppler (PD) in detecting tendinopathy in psoriatic patients with and without arthritis.

时间窗: At baseline (single study visit)

Musculoskeletal Ultrasound assessment by LOGIQ P10 from General Electric (GE) Healthcare, a division of General Electric Company

次要结局

  • Investigate the correlation between SWE, GS ultrasound and PD finding and SIRT2 expression levels and evaluate the correlation of the imaging finding and SIRT2 levels with psoriatic arthritis disease activity score (PASDAS).(At baseline (single study visit))

研究者

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

Nada Mahmoud Mostafa Nasr Elshenawy

Specialist of Rheumatology, Rehabilitation and Physical Medicine , Assiut University Hospitals

Assiut University

研究点 (1)

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