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Completed

NCT Number: NCT06094686

Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis

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'

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arterial Occlusive Diseases Arteriosclerosis Arthritis Atherosclerosis Axial Spondyloarthritis Bone Diseases Cardiovascular Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

epicardial adipose tissue thickness

Diagnostic Test

EATT measured via transthoracic echocardiography

Primary outcomes

  1. Epicardial adipose tissue thickness

    Time frame: through study completion, an average of 5 months

    Epicardial adipose tissue thickness is measured via transthoracic echocardiography

Secondary outcomes

  1. Bath Ankylosing Spondylitis Disease Activity Index

    Time frame: through study completion, an average of 5 months

    The index indicates that disease activity of AS patients. Higher scores indicate that higher activity

  2. Bath Ankylosing Spondylitis Functional Index

    Time frame: through study completion, an average of 5 months

    The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status.

  3. Bath Ankylosing Spondylitis Metrology Index

    Time frame: through study completion, an average of 5 months

    The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility.

  4. Ankylosing Spondylitis Disease Activity Score

    Time frame: through study completion, an average of 5 months

    This score is used to evaluate disease activity of AS patients. Higher scores indicate that higher activity.

  5. Six minute walk test

    Time frame: through study completion, an average of 5 months

    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.

  6. Ankylosing Spondylitis Quality of Life

    Time frame: through study completion, an average of 5 months

    it is used for evaluate quality of life of AS patients. A lower score indicates better quality of life

  7. International Physical Activity Questionnaire Short Form

    Time frame: through study completion, an average of 5 months

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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