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

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06094686
Collaborator
(none)
61
1
5.1
12.1

Study Details

Study Description

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'

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: epicardial adipose tissue thickness

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).

Study Design

Study Type:
Observational
Actual Enrollment :
61 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 2, 2016

Arms and Interventions

Arm Intervention/Treatment
Ankylosing spondylitis group

Thirty patients with AS according to the modified New York criteria were included in this cross-sectional study.

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

Healthy volunteers

Control group was consisted of 31 healthy volunteers

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

Outcome Measures

Primary Outcome Measures

  1. Epicardial adipose tissue thickness [through study completion, an average of 5 months]

    Epicardial adipose tissue thickness is measured via transthoracic echocardiography

Secondary Outcome Measures

  1. Bath Ankylosing Spondylitis Disease Activity Index [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Nur Kesiktas, MD, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06094686
Other Study ID Numbers:
  • IstPRMTRH5
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023