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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05914532
Other study ID # 19/08/2022, 2011-KAEK-50: 262
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2023
Est. completion date August 10, 2023

Study information

Verified date August 2023
Source Istanbul Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).


Description:

The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date August 10, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria - 51 healthy controls working in our hospital, Exclusion Criteria: infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
lab testing
Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.

Locations

Country Name City State
Turkey Istanbul Training and Resarch Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of SIRI and SII between Patient and Healthy Control SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Baseline
Secondary Correlation analysis of SIRI and SII with scales and laboratory findings SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Baseline
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