NCT06094686

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'

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2016

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

October 10, 2023

Last Update Submit

February 18, 2024

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitisatherosclerosisepicardial adipose tissue thickness

Outcome Measures

Primary Outcomes (1)

  • Epicardial adipose tissue thickness

    Epicardial adipose tissue thickness is measured via transthoracic echocardiography

    through study completion, an average of 5 months

Secondary Outcomes (7)

  • Bath Ankylosing Spondylitis Disease Activity Index

    through study completion, an average of 5 months

  • Bath Ankylosing Spondylitis Functional Index

    through study completion, an average of 5 months

  • Bath Ankylosing Spondylitis Metrology Index

    through study completion, an average of 5 months

  • Ankylosing Spondylitis Disease Activity Score

    through study completion, an average of 5 months

  • Six minute walk test

    through study completion, an average of 5 months

  • +2 more secondary outcomes

Study Arms (2)

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

Healthy volunteers

Control group was consisted of 31 healthy volunteers

Diagnostic Test: epicardial adipose tissue thickness

Interventions

epicardial adipose tissue thicknessDIAGNOSTIC_TEST

EATT measured via transthoracic echocardiography

Ankylosing spondylitis groupHealthy volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related 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.

    PMID: 29479952RESULT

  • 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.

    PMID: 11427222RESULT

  • 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.

    PMID: 14581396RESULT

MeSH Terms

Conditions

Spondylitis, AnkylosingAtherosclerosis

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nur Kesiktas, MD, Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 2, 2016

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

there is no plan to share any data

Locations

TU(1)