Ankylosing SpondylitisNCT06094686
Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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' Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- epicardial adipose tissue thickness
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2015to 2 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Disease duration >1 year,
- Being ≥18 years
- AS diagnosis according to modified New York Criteria
Who cannot join
- Being illiterate,
- >65 years,
- History of ischemic heart disease,
- Cerebrovascular disease,
- Hypertension,
- Chronic kidney failure,
Show all 9Show fewer
- endocrinopathies like diabetes mellitus,
- hypothyroidism,
- Cushing syndrome and primary hyperlipidemia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
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'
Read the 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).
- Conditions
- Ankylosing Spondylitis
- Being tested
- epicardial adipose tissue thickness
- Keywords
- Ankylosing spondylitis, atherosclerosis, epicardial adipose tissue thickness
- Medical subject headings
- Spondylitis, Ankylosing, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epicardial adipose tissue thicknessDiagnostic test
EATT measured via transthoracic echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing spondylitis group | Thirty patients with AS according to the modified New York criteria were included in this cross-sectional study. Receives: Diagnostic Test: epicardial adipose tissue thickness | |
| Healthy volunteers | Control group was consisted of 31 healthy volunteers Receives: Diagnostic Test: epicardial adipose tissue thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial adipose tissue thickness
Epicardial adipose tissue thickness is measured via transthoracic echocardiography
Measured: through study completion, an average of 5 months
Secondary outcomes (7)
Bath Ankylosing Spondylitis Disease Activity Index
The index indicates that disease activity of AS patients. Higher scores indicate that higher activity
Measured: through study completion, an average of 5 months
Bath Ankylosing Spondylitis Functional Index
The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status.
Measured: through study completion, an average of 5 months
Bath Ankylosing Spondylitis Metrology Index
The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility.
Measured: through study completion, an average of 5 months
Ankylosing Spondylitis Disease Activity Score
This score is used to evaluate disease activity of AS patients. Higher scores indicate that higher activity.
Measured: through study completion, an average of 5 months
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.
Measured: through study completion, an average of 5 months
Ankylosing Spondylitis Quality of Life
it is used for evaluate quality of life of AS patients. A lower score indicates better quality of life
Measured: through study completion, an average of 5 months
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.
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Aug 2015
- Primary completion1 Jan 2016
- Study completion2 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nur Kesiktas, MD, Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094686
- Sponsor's protocol ID
- IstPRMTRH5
- Status last verified
- Feb 2024
- First submitted
- 10 Oct 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to share any data
Publications
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.
PubMed 29479952Taguchi 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.
PubMed 11427222Mazurek 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.
PubMed 14581396
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT06094686
- Acronym / sponsor ID
- IstPRMTRH5
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, atherosclerosis, epicardial adipose tissue thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 2 Jan 2016 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylosing spondylitis group | – | Diagnostic Test: epicardial adipose tissue thicknessThirty patients with AS according to the modified New York criteria were included in this cross-sectional study. |
| Healthy volunteers | – | Diagnostic Test: epicardial adipose tissue thicknessControl group was consisted of 31 healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Disease duration >1 year,
- Being ≥18 years
- AS diagnosis according to modified New York Criteria
Key exclusion criteria (9 listed)
- Being illiterate,
- >65 years,
- History of ischemic heart disease,
- Cerebrovascular disease,
- Hypertension,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epicardial adipose tissue thicknessEATT measured via transthoracic echocardiography | Diagnostic test | Ankylosing spondylitis group, Healthy volunteers |
Primary outcome
Epicardial adipose tissue thickness
Time frame: through study completion, an average of 5 months
Epicardial adipose tissue thickness is measured via transthoracic echocardiography
7 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: through study completion, an average of 5 months
Bath Ankylosing Spondylitis Functional Index
Time frame: through study completion, an average of 5 months
Bath Ankylosing Spondylitis Metrology Index
Time frame: through study completion, an average of 5 months
Ankylosing Spondylitis Disease Activity Score
Time frame: through study completion, an average of 5 months
Six minute walk test
Time frame: through study completion, an average of 5 months
Ankylosing Spondylitis Quality of Life
Time frame: through study completion, an average of 5 months
International Physical Activity Questionnaire Short Form
Time frame: through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 29479952Keresztesi 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.
- Results publication: PubMed 11427222Taguchi 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.
- Results publication: PubMed 14581396Mazurek 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.
- Individual participant dataSharing planned: No. there is no plan to share any data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Kesiktas, MD, Prof study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial adipose tissue thickness (time frame: through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094686, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.