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Status unknownNCT04891783Updated May 21, 2021

Investigating Atherosclerosis In Seronegative Spondyloarthropathy

An observational study in In Seronegative Spondyloarthropathy, sponsored by Sohag University. Status unknown. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
120
Ages
16 Years and older
Sex
All
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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].

Read the detailed description

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 . Rheumatoid arthritis (RA) has the greatest CV impact. Scientific societies and expert groups have developed recommendations for preventing cardiovascular risk in these patients . 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).

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.

The psoriatic disease concept includes psoriatic arthritis (PsA). PsA is a chronic inflammatory skeletal disease associated with psoriasis. PsA has heterogeneous clinical manifestations with some forms linked to the spondyloarthritis(SpA) concept. A strong relationship of PsA with SpA is clearly supported by shared clinical, genetic, and radiographic characteristics.

CV comorbidities are critically important in this patient population because they may directly contribute to increased mortality seen in patients PsA.

Sustained chronic systemic inflammation predisposes to atherosclerosis as it is accompanied by elevated levels of serum C-reactive protein (CRP), which has proatherogenic effects. Also, hypertension, sex, and smoking are predisposing factors with chronic inflammation in atherosclerosis.3 Moreover, AS has been associated with a prevalence of metabolic syndrome including dyslipidemia and a high ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol .

SerumIrisin, asa novel hormone-like myokine that plays a pivotal role in energy expenditure and metabolic regulation, is mainly secreted by the heart, skeletal muscle, liver, kidneys, nerves

, and skin.Previous studies revealed the relationship between circulating irisin levels, endothelial dysfunctions, and subclinical atherosclerosis in non-diabetic adult patients.[18]In another recent study, it was demonstrated that serum irisin level was significantly correlated with carotid atherosclerosis in patients receiving dialysis.

As a consequence of the aforementioned considerations, the prevention of CV events has become an issue of great concern in the treatment of chronic inflammatory diseases. Primary prevention strategies designed for the general population are based on the performance of composite scores to estimate the total CV risk, thus identifying those individuals at higher risk who may benefit from active therapy. The 2019 ESC/EAS guidelines for the treatment of dyslipidemias also recommend considering the assessment of carotid plaque burden on ultrasound as a risk modifier in people with low or moderate CV risk. According to these guidelines, the presence of carotid plaques would automatically imply the reclassification of an individual as having very high CV risk [21]. This recommendation seems particularly useful for patients with inflammatory conditions, whose CV risk tends to be underestimated by composite scores because of not considering important pro-atherogenic factors related to the disease such as inflammation.

02

Conditions studied

03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's planned enrollment of 120 is below the median of 202 across 256 observational studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Deviceultrasonography

    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

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What researchers measure

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.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 25890227 ↗
  • 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. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4255. doi: 10.1093/eurheartj/ehz826. PubMed 31504418 ↗
  • 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. PubMed 16871531 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04891783
Lead sponsor
Sohag University
Responsible party
Salma Mohamed Shabaan (assistant lecturer, Sohag University) — Principal investigator
First posted
May 18, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
May 21, 2021

Study contacts

Salma S Farghali, Dr
Contact
salma.farghali@med.sohag.edu.eg
01063325883
Hanan S Mohamed, Professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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