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How using carotid artery ultrasounds affects taking cholesterol medications

Effect of use of carotid artery point-of-care ultrasonography on lipid lowering drug adherence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10591599
Enrollment
500
Registered
2024-07-26
Start date
2023-03-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low statin adherence in apparently healthy individuals with high and very high CVD risk. Circulatory System

Interventions

Patients meeting the inclusion criteria and signing the informed consent form will be randomized within each clinic (randomization performed by the e-CRF program). In the intervention group, carotid a

Sponsors

KRKA, tovarna zdravil, d.d., Novo Mesto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 40 to 69 years 2. CVD risk evaluated as high or very high 3. No prior use of antilipemic drugs

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus type 1 or type 2 2. Carotid ultrasound conducted in the past 5 years 3. Chronic kidney disease 4. Previously known cvd 5. Family hypercholesterolemia 6. Active malignant disease 7. “Difficult to manage” psychiatric disorder 8. Language barrier (subject’s knowledge of slovene language is inadequate for appropriate communication with physician) 9. Estimated life expectancy of less than 1 year.

Design outcomes

Primary

MeasureTime frame
Fasting blood LDL cholesterol levels will be measured using blood test before intervention and 9 months after intervention.

Secondary

MeasureTime frame
1. Prevalence of atherosclerotic plaques in the carotid arteries of apparently healthy individuals with risk factors measured using ultrasonographic recording at baseline for intervention group, at 9 months for controlled group 2. Sensitivity and specificity of identifying atherosclerotic plaques using carotid artery POCUS performed by family medicine physicians measured using ultrasonographic recording at baseline for intervention group, at 9 months for controlled group 3. Assess how the presence of atherosclerotic plaques visible to the patient affects adherence to lipid-lowering medications measured using difference in LDL cholesterol levels at baseline and in 9 months time 4. Determine how the presence of atherosclerotic plaques identified by the physician influences the intensity of the prescribed therapy measured by observing doses of prescribed medications at 6 months

Countries

Slovenia

Contacts

Public ContactAnej Kebric
anej.kebric@gmail.com+386 31700700

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026