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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06103448
Other study ID # IGA-FZS-2023-6
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date December 2024

Study information

Verified date October 2023
Source Jan Evangelista Purkyne University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Monitoring risks of cardiovascular diseases in working population (18 - 65 years old) by monitoring their BMI, ankle-brachial index with pulse wave velocity, cholesterol and glycemia.


Description:

Monitoring working population in their workplace by measuring their ankle-brachial index with pulse wave velocity, BMI, glycemia and cholesterol. Putting acquired data in correlation to their work habits, type of employment, work demands, job type, activity levels. Trying to find common predictors of cardiovascular disease. All assessed subjects must understand written and spoken Czech, must be employed in a company that consents with our data collections, must be older than 18 year old, doesn't have any bleeding disorder, doesn't have deep vein thrombosis (as it produces inaccurate data with ankle brachial index). Study will be conducted in Ustecky Region in the Czech Republic on approximately 200 subjects.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - employed in Ustecky Region Czech Republic - adult - understands spoken and written Czech - consents with assessment - works in a company that consents to assessments of their employees Exclusion Criteria: - deep vein thrombosis - not currently employed - on sick leave - bleeding disorder

Study Design


Intervention

Device:
Ankle-brachial index - system 100
Measurement of ankle brachial index on all four limbs, drawing three blood drops for point of care (POC) cholesterol meter and one drop of blood for POC glucometer

Locations

Country Name City State
Czechia University of Jan Evangelista Purkyne Ústí Nad Labem

Sponsors (1)

Lead Sponsor Collaborator
Jan Evangelista Purkyne University

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of glycemia, HDL, LDL and triacylglyceride levels Glycemia, HDL, LDL and triacylglyceride levels (mmol/l) will be measured from drops of blood by point-of-care analysers 5 minutes
Primary Body composition Using body composition scale the following markers will be counted: bone mass, body fat, muscle mass, water levels. All results will be in % 3 minutes
Primary Ankle-brachial index Ankle-brachial index (no unit) using ABI-system-100 will be counted from blood pressure measured in all four limbs (mmHg) 2 minutes
Primary Ankle brachial pulse wave velocity (baPWV) and carotid femoral pulse wave velocity (cfPWV) baPWV and cfPWV will be measure by ABI-system-100 (m/s) 2 minutes
Primary Weight measured by body composition scale (kg) 1 minute
Primary Height measured by tailor tape measure (m) 1 minute
Secondary BMI BMI (kg/m^2) will be counted from weight (kg) and height (m) 2 minutes
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