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

February 18, 2024 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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'

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epicardial adipose tissue thickness
Time Frame: through study completion, an average of 5 months
Epicardial adipose tissue thickness is measured via transthoracic echocardiography
through study completion, an average of 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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
through study completion, an average of 5 months
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.
through study completion, an average of 5 months

Collaborators and Investigators

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

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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

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 (Actual)

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 2, 2016

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no plan to share any data

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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