Prediction of the Risks of Cardiovascular Mortality

• Sponsor: Jan Evangelista Purkyne University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06103448
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 18.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Cardiovascular Morbidity; Stroke; Embolism; Cardiac Arrest	Device: Ankle-brachial index - system 100

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Prediction of the Risks of Cardiovascular Mortality
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Outcome Measures

Primary Outcome Measures

1. Detection of glycemia, HDL, LDL and triacylglyceride levels [5 minutes]

   Glycemia, HDL, LDL and triacylglyceride levels (mmol/l) will be measured from drops of blood by point-of-care analysers

2. Body composition [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. Ankle-brachial index [2 minutes]

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

4. Ankle brachial pulse wave velocity (baPWV) and carotid femoral pulse wave velocity (cfPWV) [2 minutes]

   baPWV and cfPWV will be measure by ABI-system-100 (m/s)

5. Weight [1 minute]

   measured by body composition scale (kg)

6. Height [1 minute]

   measured by tailor tape measure (m)

Secondary Outcome Measures

1. BMI [2 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Jan Evangelista Purkyně	Ústí Nad Labem		Czechia	40011

Sponsors and Collaborators

• Jan Evangelista Purkyne University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iva Volešová, Clinical Instructor, Jan Evangelista Purkyne University
• ClinicalTrials.gov Identifier: NCT06103448
• Other Study ID Numbers: IGA-FZS-2023-6
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Iva Volešová, Clinical Instructor, Jan Evangelista Purkyne University: ankle-brachial index; cardiovascular mortality; prevention
• Additional relevant MeSH terms: Cardiovascular Diseases; Embolism

Study Results

No Results Posted as of Oct 26, 2023