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VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a pragmatic randomized controlled trial nested in the Västerbotten Intervention Program

Research project Prevention of cardiovascular disease (CVD) often fails due to low adherence among physicians and individuals to prevention guidelines. Therefore, new and alternative approaches are needed. VIPVIZA evaluates the potential of visualization of silent atherosclerosis as the basis for prevention.

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 CVD risk and consequent motivation for prevention. The intervention effect was assessed by differences between randomization groups in Framingham Risk Score (FRS) and Systematic COronary Risk Evaluation (SCORE) as well as changes in these scores after one year. Results showed beneficial effects in the intervention group with a reduction of FRS as contrasted by an increase in the group that was not informed about ultrasound results. Differences between groups will also be evaluated by risk factor assessment and a further scan after three years to determine disease progression, as well as a comparison of the prevalence of acute events and mortality at five and 10 years. Social, psychological and cognitive determinants of behavioral change as well as the intervention impact on novel biomarkers will also be explored.

Head of project

Ulf Näslund
Professor/chief physician
E-mail
Email

Project overview

Project period

2013-04-29 2026-12-31

Funding

The Swedish Research Council (Dnr: 521-2013-2708, 2016-01891), the Heart and Lung Foundation (Dnr 20150369, 20170481), the Swedish Society of Medicine, the Heart Foundation in Northern Sweden, STROKE – the national association, the Foundation for Stroke Research in Northern Sweden, The Swedish Insurance Society, Visare Norr (the four Northern County Councils), SKANDIA Risk & Hälsa, and the Swedish and the Västerbotten Heart and Lung Associations. An unconditional donation was received from Carl Bennet Ltd, Sweden.

Research subject

Clinical medicine

Project description

The main objective of this project is to contribute to improved primary prevention of cardiovascular disease through the provision of a visual image and pictorial report of atherosclerosis while still asymptomatic. The image and report are seen and discussed by both physician and patient in order to improve guideline adherence and patient perception and understanding of the CVD risk and consequent motivation for prevention. The specific objectives include: 1.To assess the prevalence of asymptomatic atherosclerotic disease in men and women through identification of carotid plaques and measurement of carotid intima-media thickness (CIMT), and to relate plaques and CIMT to clinically estimated CVD risk factors and risk scores 2.To explore the impact of pictorial representations of atherosclerosis on physicians´ adherence to prevention guidelines, and on individuals' quality of life, preventive measures, risk factor control and progress of atherosclerotic disease over the course of three years, as well as on premature CVD morbidity and mortality over the course of 5 and 10 years 3.To evaluate how individuals' social, psychological, cognitive characteristics relate to atherosclerosis and CVD risk at baseline and progression of any atherosclerosis 4.To investigate biomarkers in relation to CIMT and plaques at baseline, changes in conventional CVD risk markers and lifestyle, and progression of atherosclerosis.

Survey of the field

Primary prevention of CVD often fails due to poor adherence among practitioners and patients to evidence-based prevention guidelines on effective modification of risk factors by lifestyle change and pharmacological treatment. Contributory factors include poor communication about the CVD risk by the physician and inaccurate risk perception among patients. The risk message is usually communicated verbally or numerically, while potentially more effective visual tools are seldom used. For the clinical assessment of CVD risk the FRS and the European SCORE are most widely used. However, evidence that their use translates into reduced CVD morbidity and mortality is scarce. These risk scores focus on high-risk individuals, despite 60-70% of all CVD events occurring among individuals at low or intermediate risk for CVD. They might also be too abstract to lead to accurate risk perception and to motivate to take preventive actions; information alone seldom results in rational behavior modification. VIPVIZA takes a different approach from current practice for the prevention of CVD. Instead of being based solely on indirect risk factors, this project evaluates the atherosclerotic disease itself while it still is silent, providing improved assessment, communication and perception of the CVD risk and hence greater motivation for prevention. This is achieved with ultrasonography of medium sized arteries with assessment of CIMT and existing atherosclerotic plaques.

Design, setting and study population: The study is a pragmatic randomised open-label controlled trial with blinded evaluators (PROBE). It is registered at https://clinicaltrials.gov/ct2/show/NCT01849575, where a detailed study protocol is presented. VIPVIZA is integrated in and added to the ordinary Västerbotten Intervention Programme (VIP). Individuals with at least one clinical CVD risk factor were invited to the VIPVIZA trial when they participated in VIP (n=4177), resulting in inclusion of of 3532 participants. Baseline visits with ultrasound examinations were carried out from April 2013 to June 2016. Participants were consecutively and randomly allocated to two groups (intervention and control group) using a computer-generated randomization list. The ultrasound examinations in VIPVIZA at baseline as well as after three years were performed at the hospitals in the three cities/towns (Umeå, Skellefteå, Lycksele), and in remote rural areas at primary health care centres. Risk factor measurements and questionnaires at follow-up after one and three years are carried out for participants living in Umeå at the Clinical Research Centre at Umeå University Hospital, and for participants in the rest of the county at their local primary health care center. Both groups were managed according to clinical guidelines for CVD prevention within primary care (not by the study team).

Intervention: Pictorial representation of the carotid ultrasound results was given to each participant in the intervention group and their primary care physician. Atherosclerosis was presented as vascular age, with a gauge ranging from green through yellow, orange and red to illustrate the individual's biological, compared to chronological, age. A red or a green circle, like a traffic light, illustrated detected or no detected plaque, respectively. Brief written information about atherosclerosis as a dynamic process that is modifiable by a healthy lifestyle and pharmacological treatment, an interpretation of the result and general advice on CVD prevention were included. After 2-4 weeks, participants received a follow-up phone call by a research nurse in order to reassure and give additional information as needed. The same pictorial information was repeated to participants after 6 months. No information about the ultrasound result was given to the control group and their physicians.

Data collection:

Clinical risk factors for cardiovascular disease: Measured at the baseline VIP health survey and at 1- and 3-year follow-up (blood pressure, lipids, and glucose, BMI and waist circumference).
Questionnaires: The VIP questionnaire covers health, socioeconomic situation, quality of life (RAND 36), lifestyle (physical activity, tobacco and alcohol consumption, diet), working conditions, social network. Validated psychometric instruments at baseline and 3-year follow-up included health literacy, coping strategies, an optimism-pessimism scale, self-efficacy, HADS and self-rated risk of CVD. Perceptions about preventive medication and a stress questionnaire at the 3-year follow-up.
Carotid ultrasound examinations are performed at baseline and after 3 years according to a standardized protocol.
Interviews: With participants after the first and second ultrasound examination, and with primary care physicians after the first ultrasound examination.
Stored samples of blood to the Medical Biobank: This was done at the baseline VIP visit and at 3-year follow-up among participants living in Umeå, to be used for analyses of novel biomarkers
Register data: Prescriptions, visits and risk factor measurements from the Medical records system in Västerbotten county. The Prescriptions register, Hospitalizations register and Causes of deaths register at the National Board of Health and Welfare.

Results as at December 2018:

Overall, the extent of the impact is assessed by differences between randomization groups in Framingham Risk Score and SCORE as well as changes in these scores after one and three years. Differences between groups and psychological, cognitive and social determinants of preventive measures will also be evaluated by risk factor assessment and a further scan after three years to determine disease progression, and a comparison of the prevalence of acute events and mortality at five and 10 years. Novel biomarkers will be evaluated in relation to disease progression.

The use of the ultrasound equipment by non-specialized personnel was evaluated (1). The influence of electrocardiogram-guided image selection, plaque echogenicity and area on carotid plaque risk markers and their variability in asymptomatic carotid plaques was published (2). The primary outcome, levels of FRS and SCORE after one year as well as changes in FRS and SCORE, differed significantly between the intervention and the control group at the one-year assessment (3). This result provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease.

Time plan: The study progress is according to the plan. Baseline examinations were conducted April 2013–June 2016, the 1–year follow-up examinations June 2014-–August 2017. The 3–year examinations started September 2016 and will be completed August 2019. Register data on morbidity and mortality will be retrieved in 2021 and 2026.

PUBLICATIONS December 2018

1. Vanoli D, Wiklund U, Lindqvist P, Henein M, Naslund U. Successful novice's training in obtaining accurate assessment of carotid IMT using an automated ultrasound system. European heart journal cardiovascular Imaging. 2014;15(6):637-42.
2. Nyman E, Lindqvist P, Naslund U, Gronlund C. Risk Marker Variability in Subclinical Carotid Plaques Based on Ultrasound is Influenced by Cardiac Phase, Echogenicity and Size. Ultrasound Med Biol. 2018;44(8):1742-50.
3. Näslund, U, Ng N, Lundgren A, Fhärm E, Grönlund C, et al for the VIPVIZA trial group. The Lancet Published online December 3, 2018 http://dx.doi.org/10.1016/S0140-6736(18)32818-6