Prediction of the Risks of Cardiovascular Mortality

October 25, 2023 updated by: Iva Volešová, Jan Evangelista Purkyne University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ústí Nad Labem, Czechia, 40011
        • University of Jan Evangelista Purkyně
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Working individuals with employment contract in Ustecky Region, that are able to consent to assessment, are adults and understand written and spoken Czech language. Random companies from Ustecky region will be approached with the opportunity to participate.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of glycemia, HDL, LDL and triacylglyceride levels
Time Frame: 5 minutes
Glycemia, HDL, LDL and triacylglyceride levels (mmol/l) will be measured from drops of blood by point-of-care analysers
5 minutes
Body composition
Time Frame: 3 minutes
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
Ankle-brachial index
Time Frame: 2 minutes
Ankle-brachial index (no unit) using ABI-system-100 will be counted from blood pressure measured in all four limbs (mmHg)
2 minutes
Ankle brachial pulse wave velocity (baPWV) and carotid femoral pulse wave velocity (cfPWV)
Time Frame: 2 minutes
baPWV and cfPWV will be measure by ABI-system-100 (m/s)
2 minutes
Weight
Time Frame: 1 minute
measured by body composition scale (kg)
1 minute
Height
Time Frame: 1 minute
measured by tailor tape measure (m)
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 2 minutes
BMI (kg/m^2) will be counted from weight (kg) and height (m)
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Evangelista Purkyne University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA-FZS-2023-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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