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Clinical Trials in Sweden / NCT01849575
Active, not recruiting Not applicable

Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention

NCT01849575 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Not applicable
Started
2013-04-07
Last updated
2026-06-29

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

Intervention

Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.

Study summary

The purpose of VIPVIZA is to assess the impact of pictorial information about asymptomatic atherosclerotic disease to both physician and patient, for improving physicians' adherence to prevention guidelines and patient perception and understanding of the cardiovascular disease (CVD) risk and consequent motivation for prevention. The intervention effect is assessed by differences between randomization groups in the primaryboutcome Framingham Risk Score (FRS) and the secondary outcomes the Systematic COronary Risk Evaluation (SCORE) as well as changes in these scores after one, three and six years. Secondary outcomes are also atherosclerotic disease progression, as assessed by repeated carotid ultrasound examination after three and six years, as well as the prevalence of acute events and mortality after 10 years . Social, psychological and cognitive determinants of behavioral change as well as the intervention impact on novel biomarkers will also be explored.

Eligibility

Sex
ALL
Min age
40 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: \- Participant in the Västerbotten Intervention Programme and * 40 years old and a history of CVD at age \< 60 years among first-degree relative or * 50 years old and at least one of the following six criteria: * a history of CVD at age \< 60 years among first-degree relative, * smoking, * diabetes, * hypertension, * S-LDL-cholesterol ≥4.5 mmol/L, * abdominal obesity or * 60 years old Exclusion Criteria: * Stenosis ≥50% of the carotid lumen

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Clinical Reseach Center Umeå University Hospital Umeå Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01849575 on ClinicalTrials.gov ↗ ← All trials in Sweden