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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06094686
Other study ID # IstPRMTRH5
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2015
Est. completion date January 2, 2016

Study information

Verified date February 2024
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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'


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).


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date January 2, 2016
Est. primary completion date January 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
epicardial adipose tissue thickness
EATT measured via transthoracic echocardiography

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Epicardial adipose tissue thickness Epicardial adipose tissue thickness is measured via transthoracic echocardiography through study completion, an average of 5 months
Secondary Bath Ankylosing Spondylitis Disease Activity Index The index indicates that disease activity of AS patients. Higher scores indicate that higher activity through study completion, an average of 5 months
Secondary Bath Ankylosing Spondylitis Functional Index The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status. through study completion, an average of 5 months
Secondary Bath Ankylosing Spondylitis Metrology Index The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility. through study completion, an average of 5 months
Secondary Ankylosing Spondylitis Disease Activity Score This score is used to evaluate disease activity of AS patients. Higher scores indicate that higher activity. through study completion, an average of 5 months
Secondary Six minute walk test This test is used to evaluate the patient's functional capacity. In case of low functional capacity, lower scores are observed. Higher scores indicate that higher activity. through study completion, an average of 5 months
Secondary Ankylosing Spondylitis Quality of Life it is used for evaluate quality of life of AS patients. A lower score indicates better quality of life through study completion, an average of 5 months
Secondary International Physical Activity Questionnaire Short Form it is used for evaluate patient's physical activity. Scoring a high level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level. through study completion, an average of 5 months
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