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Cardiovascular DiseasesNCT06103448

Prediction of the Risks of Cardiovascular Mortality

An observational study of Cardiovascular Diseases and Cardiovascular Morbidity, run by Jan Evangelista Purkyne University at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Ankle-brachial index - system 100
Type of treatment
Medical device
How many people
200 participants
Where
1 siteCzechia
Study dates
Jan 2024to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • University of Jan Evangelista Purkyně

    Ústí nad Labem, 40011

    Iva Volešová, MSc., +420475284263, iva.volesova@ujep.cz

Other trials in Czechia

About this study

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.

Read the 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.

Being tested
Ankle-brachial index - system 100
Keywords
ankle-brachial index, cardiovascular mortality, prevention
Medical subject headings
Cardiovascular Diseases, Stroke, Embolism, Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ankle-brachial index - system 100Device

    Also called Point of care cholesterol meter by Lux and point of care Glucometers

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 minutes

  2. 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 %

    Measured: 3 minutes

  3. Ankle-brachial index

    Ankle-brachial index (no unit) using ABI-system-100 will be counted from blood pressure measured in all four limbs (mmHg)

    Measured: 2 minutes

  4. 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)

    Measured: 2 minutes

  5. Weight

    measured by body composition scale (kg)

    Measured: 1 minute

  6. Height

    measured by tailor tape measure (m)

    Measured: 1 minute

Secondary outcomes (1)

  1. BMI

    BMI (kg/m^2) will be counted from weight (kg) and height (m)

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06103448
Sponsor's protocol ID
IGA-FZS-2023-6
Status last verified
Oct 2023
First submitted
11 Oct 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Cardiovascular Morbidity, run by Jan Evangelista Purkyne University at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of glycemia, HDL, LDL and triacylglyceride levels (time frame: 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06103448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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