Investigating Atherosclerosis In Seronegative Spondyloarthropathy

May 18, 2021 updated by: Salma Mohamed Shabaan, Sohag University

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].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

120

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

  • Name: Hanan S Mohamed, Professor

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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:

  • 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.

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
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
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 .
Other Names:
  • MRI
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
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 .
Other Names:
  • MRI
40 healthy controls
healthy controls will undergo carotid ultrasound examination
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 .
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the presence of atherosclerosis in two diseases of seronegative spondyloarthropathy ankylosing spondylitis and psoriatic arthritis patients
Time Frame: 2 years
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

Collaborators and Investigators

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

Sponsor

Sohag University

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.

General Publications

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-05-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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