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Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention

NCT01849575 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3532

Last updated 2024-01-17

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Västerbotten County Council, Sweden

    collaborator OTHER_GOV

  • Umeå University

    lead OTHER

Principal Investigators

  • Patrik Wennberg, MD, PhD · Umeå University

  • Ulf Näslund, Professor,MD · Umeå University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-07
Primary Completion
2017-11-10
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01849575 on ClinicalTrials.gov