Investigating Atherosclerosis In Seronegative Spondyloarthropathy

NCT04891783 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2021-05-21

No results posted yet for this study

Summary

The association between inflammation and atherosclerosis is widely known. An increase in morbidity and mortality due to cardiovascular (CV) disease in inflammatory rheumatic diseases has been proved \[1-4\]. Rheumatoid arthritis (RA) has the greatest CV impact. Scientific societies and expert groups have developed recommendations for preventing cardiovascular risk in these patients \[5, 6\]. It has also been observed an increased CV risk and greater morbidity in other inflammatory rheumatic diseases such as Ankylosing Spondylitis (AS), psoriatic arthritis (PsA), and inflammatory bowel disease(IBD) \[1, 7n, 8\].

Ankylosing spondylitis (AS) is a systemic inflammatory disorder of unknown etiology that mainly involves the axial skeleton causing the spine, sacroiliac joints arthritis, and peripheral joints arthritis. Its peak age of onset is between 20-30 years affecting young males with the involvement of extra-articular structures such as eyes, kidneys, heart, lung, vessels, and nerves \[9,10\]. Aortitis and aortic regurgitation are cardiovascular complications associated with AS. AS is associated with up to 50% mortality rates and cardiovascular diseases are the main causes of these high mortality rates\[10,11\].

Conditions

  • In Seronegative Spondyloarthropathy

Interventions

DEVICE

ultrasonography

The Carotid US examination will be performed by a radiologist, according to the same protocol in the different participating hospitals. It will include the measurement of cIMT in the common carotid artery and the detection of focal plaques in the extracranial carotid tree following the Mannheimconsensus\[26\]. Plaque is defined as a focal protrusion in the lumen at least cIMT\>1.5 mm, protrusion at least 50% greater than the surrounding cIMT, or arterial lumen encroaching \>0.5 mm \[26\]. The cIMT will be determined as the average of three measurements in each common carotid artery. The final cIMT is the largest average cIMT (left or right). Patients with carotid plaques will be considered as having very high CV .

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-06-30
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891783 on ClinicalTrials.gov