Inturlekin L33 in Ankylosing Spondylities Patients and Its Relation to Subclinical Atherosclerosis

August 20, 2024 updated by: Aya Mohamed Hussein AbuAli, Assiut University

Inturlekin 33 in Ankylosing Spondylitis Patients and Its Relationship to Subclinical Atherosclerosis

detect level of Inturlekin 33 in ankylosing spondyilits patient

measure CIMT (carotid intima media thickness ) by carotid duplex to detect subclinical atherosclerosis in ankylosing spondyitis patients

detect the relation between IL33 and subclinical atherosclerosis in Ankylosinig Spondylitis patients

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Ankylosing spondylitis (AS), a type of SpA, is an autoimmune disease that mainly involves, sacroiliac joints (SIJs) and their adjacent soft tissues, such as tendons and ligaments. The main clinical manifestations include back pain and progressive spinal rigidity as well as inflammation of the hips, shoulders, peripheral joints and fingers/toes. In addition, there are extra-articular manifestations.

Cardiovascular disease has become the first cause of death for patients with ankylosing spondylitis (AS).

Patients with ankylosing spondylitis (AS) have an increased cardiovascular morbidity and mortality . Accelerated atherosclerosis caused by a systemic inflammatory response has been reported to be an important risk factor for increased cardiovascular risk for autoimmune diseases.

Interleukin (IL)-33 is a cytokine belonging to the IL-1 family and was recently identified as a ligand for ST2, .the serum levels of IL-33/sST2 were remarkably higher in the patients with AS than the healthy groups .

Pervious studies confirm the importance of IL-33/ST2 axis in the process of atherosclerosis, and indicate its ambiguous function in immune response, whether as proinflammatory cytokine in advanced atherosclerotic lesions, or as profibrotic, in early lesions.

Previous study shows increased CIMT in AS patients without traditional cardiovascular risk factors compared to healthy controls.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • patient diagnosed as Ankylosing Spondylitis according to ASAS 2009
  • Age (20-40)

Description

Inclusion Criteria:

  • patient diagnosed as Ankylosing Spondylitis
  • Age (20-40)

Exclusion Criteria:

  • Patients with other rheumatic diseases/other SPA types

    • Participants with history of CVD event in past or present
    • Patient experiencing cardiovascular revascularization surgery or cerebrovascular disorder within past 6 months.
    • Patient with other risk factor for atherosclerosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ankylosing spondylities patients

detect level of IL33 in serum of AS patients

measure carotid intima media thickness by caroid dupex

measure Carotid intima media thickness
control persons

detect level of IL33 in serum of normal control group

measure carotid intima media thickness by caroid dupex

measure Carotid intima media thickness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect level of IL33 in AS patients
Time Frame: 3 years
measure level of IL33 in the serum of AS patients measure caroid intima media thickness CIMT in AS patients
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect the reation between IL33 and subclinical atherosclerosis in AS patients
Time Frame: 3 years
measure caroid intima media thickness CIMT in AS patients
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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