Clinical trial NCT06094686: Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis
Official title: Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
atherosclerosis
epicardial adipose tissue thickness
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AS that came to Istanbul Physical Medicine and Rehabilitation Education and Research Hospital outpatient clinic between August 2015 and January 2016

Brief summary: The aim of this study was to assess the EATT and the related factors in patients with AS and to compare the results with that of the healthy controls'

Detailed description: The aim of this study was to investigate the epicardial adipose tissue thickness (EATT) and the related factors in patients with ankylosing spondylitis (AS) and to compare the results with those of the healthy controls. This cross-sectional study comprised thirty patients diagnosed with AS based on the modified New York criteria. The control group consisted of 31 healthy volunteers. Demographic characteristics were recorded. EATT was measured via transthoracic echocardiography. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Quality of Life (ASQoL), International Physical Activity Questionnaire Short Form (IPAQ-Short Form) were used. Functional capacity assessment was conducted using the six-minute walk test (6MWT).

Eligibility criteria: Inclusion Criteria:

* Disease duration \>1 year,
* Being ≥18 years
* AS diagnosis according to modified New York Criteria

Exclusion Criteria:

* Being illiterate,
* \>65 years,
* History of ischemic heart disease,
* Cerebrovascular disease,
* Hypertension,
* Chronic kidney failure,
* endocrinopathies like diabetes mellitus,
* hypothyroidism,
* Cushing syndrome and primary hyperlipidemia.

Primary outcomes:
measure: Epicardial adipose tissue thickness
timeFrame: through study completion, an average of 5 months
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: through study completion, an average of 5 months
measure: Bath Ankylosing Spondylitis Functional Index
timeFrame: through study completion, an average of 5 months
measure: Bath Ankylosing Spondylitis Metrology Index
timeFrame: through study completion, an average of 5 months
measure: Ankylosing Spondylitis Disease Activity Score
timeFrame: through study completion, an average of 5 months
measure: Six minute walk test
timeFrame: through study completion, an average of 5 months
measure: Ankylosing Spondylitis Quality of Life
timeFrame: through study completion, an average of 5 months
measure: International Physical Activity Questionnaire Short Form
timeFrame: through study completion, an average of 5 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Nur Kesiktas, MD, Prof
role: STUDY_CHAIR
References:
citation: Keresztesi AA, Asofie G, Simion MA, Jung H. Correlation between epicardial adipose tissue thickness and the degree of coronary artery atherosclerosis. Turk J Med Sci. 2018 Feb 23;48(1):40-45. doi: 10.3906/sag-1604-58.
citation: Taguchi R, Takasu J, Itani Y, Yamamoto R, Yokoyama K, Watanabe S, Masuda Y. Pericardial fat accumulation in men as a risk factor for coronary artery disease. Atherosclerosis. 2001 Jul;157(1):203-9. doi: 10.1016/s0021-9150(00)00709-7.
citation: Mazurek T, Zhang L, Zalewski A, Mannion JD, Diehl JT, Arafat H, Sarov-Blat L, O'Brien S, Keiper EA, Johnson AG, Martin J, Goldstein BJ, Shi Y. Human epicardial adipose tissue is a source of inflammatory mediators. Circulation. 2003 Nov 18;108(20):2460-6. doi: 10.1161/01.CIR.0000099542.57313.C5. Epub 2003 Oct 27.