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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05637905
Other study ID # MCP-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date June 2025

Study information

Verified date November 2022
Source Assiut University
Contact Amira Anas, Master
Phone 01066633924
Email amiraanas60@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Evaluate serum levels of (MCP-1) in PsA with or without cardiovascular affaction . 2. Detect subclinical cardiovascular affaction in patients with PsA for early diagnosis and management .


Description:

Psoriatic arthritis (PSA) is an autoimmune disease arising from the interply between proinflamatory cytokines [1]and external stimuli in genetically predisposed individuals.[2] - The disease is chronic and affects the peripheral joints and may include axial skeleton with or without extrarticular manifestations.[3] - Abnormal activation of the innate and adaptive immune systems contributes to chronic disease processes in both psoriasis and PSA .[4] The skin and the joints exhibit a prominent lymphocytic infiltrate consisting of activated CD4+ and CD8+ T cells as well as an increase in neutrophil infiltration[5]. Patients with PsA have a higher risk of developing a cardiovascular(CV) events than the general population. This could be attributed to the higher prevalence of traditional cardiovascular risk factors and to the disease characteristics such as systemic inflammation. [6] These patients may show asymptomatic cardiomyopathy even in the absence of traditional risk factors [7].Cardiac dysfunction is associated with a poor prognosis, increased mortality, and affact socioecenomic function of patients therefore, the diagnosis of the cardiac dysfunction in the asymptomatic phase of the disease [8] is important for the timely introduction of therapy [9].Monocyte chemotactic protien1(MCP-1) is a member of chemotactic chemokines(CC) which are secreted by immune effector cells and dysfunctional endothelium [10]. - The pivotal function of MCP-1 is to attract monocyte in the arterial wall through increased expression of adhesion molecules on their surface that interacts with endothelium[11]. - MCP-1 induce maturation of monocyte in the arterial wall ,which then become specialized macrophage in early atheroma and produce tissue factors supporting coagulation and proinflammatory cytokines such as IL-1 and IL-6. It affects the functions of the surrounding immune effector cells in locally thickened intima.[12] - During active disease in psoriatic skin lesions and synovial tissue, activated monocytes represent the major source of proinflammatory mediators, including the chemokine MCP-1 [13]. MCP-1 is thought to be involved in the pathogenesis of oedema and bone erosion in patients with PsA [14].


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date June 2025
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - PsA patients (age = 18years) who fulfilled the CASPAR classification criteria[15]for psoriatic arthritis Exclusion Criteria: - PsA patients with 1. infection. 2. bone marrow disorders. 3. other autoimmune diseases. 4. diabetes. 5. hypertention . 6. hyperlipidemia. 7. liver diseases. 8. renal diseases.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary MCP-1 :Evaluate serum levels of monocyte chemoattractant protein-1(MCP-1) in relation to echocardiographic changes in patient with psoriatic arthritis. two month
Secondary Echocardiography b.Detect subclinical cardiovascular affaction in patient with psoriatic arthritis. two month
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