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Psoriatic ArthritisNCT05637905

Monocyte Chemoattractant Protein-1 in Psoriatic Arthritis Patients

An observational study of Psoriatic Arthritis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 . Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psoriatic Arthritis
How many people
44 participants
Where
No sites listed yet
Study dates
Jan 2023to Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: psoriatic arthritis patients with or without clinically cardiovascular affaction

Who may be able to join

  • PsA patients (age ≥ 18years) who fulfilled the CASPAR classification criteria[15]for psoriatic arthritis

Who cannot join

  • PsA patients with
  • infection.
  • bone marrow disorders.
  • other autoimmune diseases.
  • diabetes.
  • hypertention .
Show all 9Show fewer
  • hyperlipidemia.
  • liver diseases.
  • renal diseases.

Trial locations and contacts

No sites are listed yet.

Amira Anas, Master contact

01066633924

amiraanas60@gmail.com

About this study

Official title: The Predictive Value of Monocyte Chemoattractant Protein -1 in the Development of Cardiovacular Events in Psoriatic Arthritis Patients

  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 .
Read the detailed 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].
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05637905
Study groupRoleWhat they receive
psoriatic arthritis patients groupNot described
health control groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MCP-1

    :Evaluate serum levels of monocyte chemoattractant protein-1(MCP-1) in relation to echocardiographic changes in patient with psoriatic arthritis.

    Measured: two month

Secondary outcomes (1)
  1. Echocardiography

    b.Detect subclinical cardiovascular affaction in patient with psoriatic arthritis.

    Measured: two month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study startJan 2023 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637905
Sponsor's protocol ID
MCP-1
Status last verified
Nov 2022
First submitted
25 Nov 2022
Last updated
6 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amira Anas, Master (01066633924, amiraanas60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MCP-1 (time frame: two month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.

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