Investigating Atherosclerosis In Seronegative Spondyloarthropathy

NCT04891783 | Unknown

• 1 other identifier: Soh-Med-21-05-11
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Investigate the presence of atherosclerosis in two diseases of seronegative spondyloarthropathy ankylosing spondylitis and psoriatic arthritis patients

  The purpose of this study is to investigate the presence of atherosclerosis based on the results of carotid ultrasound and serum irsin level in two diseases of seronegative spondyloarthropathy ankylosing spondylitis and psoriatic arthritis patients.

  2 years

Study Arms (3)

50 patients diagnosed as AS

50 patients diagnosed as AS according to 1984 modified New York criteria of AS .including radiographic and non-radiographic AS according to ASAS criteria these patients will undergo carotid ultrasound examination

Device: ultrasonography

30 patients with psoriatic arthritis

30 patients with psoriatic arthritis who will be diagnosed according to the Classification Criteria of Psoriatic Arthritis (CASPAR) study these patients will undergo carotid ultrasound examination

Device: ultrasonography

40 healthy controls

healthy controls will undergo carotid ultrasound examination

Device: ultrasonography

Interventions

ultrasonography DEVICE

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 .

Also known as: MRI

30 patients with psoriatic arthritis; 40 healthy controls; 50 patients diagnosed as AS

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be carried out as a case-control study on patients followed up in the Rheumatology and Rehabilitation outpatient clinic in Sohag University Hospitals, Faculty of Medicine: 50 patients diagnosed as AS according to 1984 modified New York criteria of AS .including radiographic and non-radiographic AS according to ASAS criteria . 30 patients with psoriatic arthritis who will be diagnosed according to the Classification Criteria of Psoriatic Arthritis (CASPAR) study And 40 healthy controls

You may qualify if:

• Age at disease onset above 16 yrs old
• Patients diagnosed as according to 1984 modified New York criteria of AS .including radiographic and non-radiographic AS according to ASAS crteriae\[22\].
• Psoriatic arthritis patients fulfilling the diagnostic criteria defined by the Classification Criteria of Psoriatic Arthritis (CASPAR\[23\]study and with a diagnosis confirmed by a rheumatologist

You may not qualify if:

• Diabetes mellitus or use of antidiabetic medication.
• Heart failure, as defined by ejection fraction \<50%.
• Renal disease.
• Chronic obstructive lung disease; pulmonary hypertension; pregnancy or obesity.
• Metabolic syndrome.
• History of cardiovascular, peripheral artery disease, or cerebrovascular events.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (3)

• Shen J, Shang Q, Li EK, Leung YY, Kun EW, Kwok LW, Li M, Li TK, Zhu TY, Yu CM, Tam LS. Cumulative inflammatory burden is independently associated with increased arterial stiffness in patients with psoriatic arthritis: a prospective study. Arthritis Res Ther. 2015 Mar 17;17(1):75. doi: 10.1186/s13075-015-0570-0.

  PMID: 25890227 BACKGROUND

• Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.

  PMID: 31504418 BACKGROUND

• Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.

  PMID: 16871531 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Salma S Farghali, Dr

CONTACT

01063325883; salma.farghali@med.sohag.edu.eg

Hanan S Mohamed, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share