NCT06103448

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 11, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

ankle-brachial indexcardiovascular mortalityprevention

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • Weight

    measured by body composition scale (kg)

    1 minute

  • Height

    measured by tailor tape measure (m)

    1 minute

Secondary Outcomes (1)

  • BMI

    2 minutes

Interventions

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

Also known as: Point of care cholesterol meter by Lux and point of care Glucometers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • deep vein thrombosis
  • not currently employed
  • on sick leave
  • bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jan Evangelista Purkyně

Ústí nad Labem, 40011, Czechia

Location

MeSH Terms

Conditions

Cardiovascular DiseasesStrokeEmbolismHeart Arrest

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and ThrombosisHeart Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 26, 2023

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations