Prediction of the Risks of Cardiovascular Mortality

Stroke Clinical Trial

Official title:

Prediction of the Risks of Cardiovascular Mortality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06103448
• Other study ID #: IGA-FZS-2023-6
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiovascular Diseases
• Cardiovascular Morbidity
• Embolism
• Stroke

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