Table of Contents
- Key Points
- Why This Research Matters
- The Problem: Prevention That Falls Short
- Study Design and Participants
- What the Ultrasound Revealed
- Key Findings: Numbers That Matter
- What This Means for Patients
- Study Limitations
- Recommendations for Patients and Doctors
- Frequently Asked Questions
- Source Information
Key Points
- In a Swedish trial of 3,532 people, showing carotid ultrasound images plus a nurse phone call improved Framingham risk scores over one year.
- The intervention group's Framingham risk score fell by 0.58 points; the control group's rose by 0.35 points, a significant difference.
- European SCORE rose in both groups, but the intervention group's increase was about half that of the control group.
- The trial was open-label, single-region, and one year long, and it measured risk scores, not actual heart attacks or strokes.
- Seeing silent atherosclerosis early may motivate patients to take medications and make lifestyle changes, but longer follow-up is needed.
Why This Research Matters
Cardiovascular disease — which includes heart attacks, strokes, and other problems caused by narrowed or blocked blood vessels — remains the leading cause of death worldwide. The World Health Organization estimates that millions of lives could be saved each year if people at risk received appropriate preventive care.
Doctors have clear, evidence-based guidelines for reducing cardiovascular risk: prescribe medications to lower blood pressure and cholesterol, and advise patients to quit smoking, improve their diet, and exercise more. Yet there is a stubborn, well-documented gap between what guidelines recommend and what actually happens in real life.
Many patients simply do not adhere to their prescribed medications or lifestyle changes. This study tackles a fundamental and intriguing question: what if patients could actually see the silent disease developing inside their own bodies? Would that visual evidence motivate them to take prevention more seriously?
The researchers behind the VIPVIZA trial — which stands for Visualization of asymptomatIc atherosclerotic disease for oPtimum cardioVascular preVention (the acronym spells "VIPVIZA" in a creative Swedish twist) — tested exactly this idea. Their results, published in The Lancet in January 2019, suggest that visual evidence of hidden disease can indeed change health outcomes.
The Problem: Prevention That Falls Short
Primary prevention means stopping disease before it ever starts. When it comes to cardiovascular disease, this involves identifying people at risk and helping them make sustainable changes. But prevention frequently fails for one simple, frustrating reason: poor adherence — among both practitioners and patients — to prevention guidelines.
The EUROASPIRE IV survey, a large cross-sectional study conducted across 14 European regions and published in the European Journal of Preventive Cardiology, painted a sobering picture. Many patients at high risk of cardiovascular disease were not achieving their blood pressure or cholesterol targets, and rates of smoking and unhealthy lifestyles remained high despite medical guidance.
A 2013 review by researcher R. Kones, published in Vascular Health and Risk Management, highlighted how undertreatment and failure to take medications as prescribed contribute significantly to what cardiologists call "residual cardiovascular risk" — the risk that remains even after standard treatments are applied.
One reason for this failure may lie in the invisible nature of risk factors. A patient cannot feel their LDL (low-density lipoprotein, or "bad") cholesterol. They cannot see their blood pressure. Doctors typically communicate risk using numbers, percentages, and abstract calculations — and research shows that numbers alone often fail to move people into action.
Standard tools like the Framingham risk score (FRS) and the European SCORE (Systematic Coronary Risk Evaluation) are widely used to estimate a person's cardiovascular risk. But a 2017 systematic review by French and colleagues, published in the Annals of Behavioral Medicine, found that while communicating personalized disease risk can promote healthy behavior change, the effects are often modest. Similarly, a 2015 review by Usher-Smith and colleagues in BMJ Open examined the impact of providing cardiovascular risk estimates to both healthcare professionals and patients — and concluded that the results were inconsistent.
The key question posed by the VIPVIZA team: can a more powerful, visual form of communication make a bigger difference than numbers alone?
Study Design and Participants
The VIPVIZA trial was a pragmatic, open-label, randomised controlled trial. Let's unpack what those terms mean:
- Pragmatic: The study was conducted in real-world clinical settings, not in a tightly controlled laboratory environment. It tested how the intervention works in everyday practice.
- Open-label: Both participants and researchers knew which group each participant was assigned to. No one was "blinded" or kept unaware of their group.
- Randomised controlled trial: Participants were assigned to groups by chance (like flipping a coin) using a computer-generated randomisation list. This is considered the gold-standard study design for testing whether an intervention works.
The study was integrated within the Västerbotten Intervention Programme, an ongoing, population-based cardiovascular disease prevention programme in northern Sweden. This programme has been running for decades and has already demonstrated significant reductions in both all-cause and cardiovascular mortality — a 2015 analysis by Blomstedt and colleagues, based on 1 million person-years of follow-up, confirmed its long-term impact.
Who was eligible to participate? Individuals aged 40, 50, or 60 years with one or more conventional cardiovascular risk factors — such as high blood pressure, high cholesterol, smoking, diabetes, or a family history of heart disease.
Between April 29, 2013, and June 7, 2016, a total of 3,532 individuals were enrolled in the study.
Each participant underwent:
- A clinical examination
- Blood sampling
- Ultrasound assessment of carotid intima-media wall thickness (CIMT) and plaque formation
Participants were then randomly assigned in a 1:1 ratio to one of two groups:
- Intervention group (1,749 participants): Received a pictorial representation of their carotid ultrasound results, followed by a nurse phone call to confirm they understood the findings.
- Control group (1,783 participants): Were not informed of their ultrasound results.
The primary outcomes were the Framingham risk score (FRS) and the European SCORE, both assessed after 1 year of follow-up. These are validated risk calculators that estimate a person's probability of experiencing a cardiovascular event — the FRS estimates 10-year risk of developing cardiovascular disease, while SCORE estimates 10-year risk of a fatal cardiovascular event.
The study was registered with ClinicalTrials.gov under the number NCT01849575, ensuring transparency and accountability in research conduct.
What the Ultrasound Revealed
The carotid arteries are the main blood vessels on each side of your neck that carry oxygen-rich blood to your brain. Carotid intima-media thickness (CIMT) is a measurement taken using ultrasound that quantifies the thickness of the inner two layers of the carotid artery wall — specifically the intima and the media.
An increased CIMT indicates the presence of subclinical atherosclerosis — meaning the arteries are beginning to accumulate plaque (a buildup of fat, cholesterol, calcium, and other substances) but the patient has no symptoms yet. In addition to measuring wall thickness, the ultrasound can also detect the presence of atherosclerotic plaques — localised areas of abnormal thickening that can eventually rupture, causing a blood clot that leads to a heart attack or stroke.
Why is CIMT a useful measurement? Decades of research have established that CIMT is a reliable predictor of future cardiovascular events. The PROG-IMT collaboration, which pooled data from multiple studies across Europe, confirmed that common carotid intima-media thickness and its rate of change predict cardiovascular events in individuals at high cardiovascular risk.
The Tromsø Study, which followed 6,584 men and women in Norway for 10 years, found that both carotid plaque area and intima-media thickness were strong predictors of first-ever ischemic stroke — a stroke caused by a blocked blood vessel in the brain.
The American Society of Echocardiography has issued a consensus statement supporting the use of carotid ultrasound to identify subclinical vascular disease and evaluate cardiovascular risk. A 2012 meta-analysis by Den Ruijter and colleagues, published in the Journal of the American Medical Association (JAMA), confirmed that CIMT measurements improve cardiovascular risk prediction beyond traditional risk factors.
In the VIPVIZA trial, the ultrasound images were presented to intervention group participants in a simple, visual format. Patients could see, with their own eyes, where plaque was building up in their arteries. This was reinforced by a nurse phone call to ensure the patient fully understood the findings. The idea was simple: seeing is believing.
Key Findings: Numbers That Matter
After 1 year, 3,175 of the 3,532 enrolled participants completed the follow-up assessment — a completion rate of approximately 90%, which is excellent for a pragmatic trial. The results showed significant differences between the intervention and control groups.
Framingham Risk Score (FRS) Results
The Framingham risk score estimates a person's 10-year risk of developing cardiovascular disease, including heart attacks, strokes, and other cardiovascular events. It was originally developed from the landmark Framingham Heart Study, which began in 1948 in Framingham, Massachusetts.
At the 1-year follow-up, the difference in FRS between the two groups was 1.07 points (95% confidence interval 0.11 to 2.03, p=0.0017), meaning the intervention group had significantly lower risk scores than the control group.
Looking at the change from baseline:
- Intervention group: FRS decreased by −0.58 (95% CI −0.86 to −0.30)
- Control group: FRS increased by +0.35 (95% CI 0.08 to 0.63)
In plain terms: patients who saw their artery images improved their risk scores over the course of a year, while those who did not see images got slightly worse. The control group's increase is what you would typically expect as people age, so the fact that the intervention group moved in the opposite direction is striking.
SCORE Results
The European SCORE (Systematic Coronary Risk Evaluation) estimates a person's 10-year risk of dying from a cardiovascular event — a more specific and serious outcome than the FRS. It is endorsed by the European Society of Cardiology guidelines.
At 1 year, the difference in SCORE between groups was 0.16 (95% CI 0.02 to 0.30, p=0.0010), again favouring the intervention group. However, SCORE increased in both groups:
- Intervention group: SCORE increased by +0.13 (95% CI 0.09 to 0.18)
- Control group: SCORE increased by +0.27 (95% CI 0.23 to 0.30)
So while both groups' risk scores rose over the year (as is natural with aging), the intervention group's increase was roughly half that of the control group.
What Do the Statistics Mean?
The p-values of 0.0017 and 0.0010 indicate that these results are statistically significant — meaning there is less than a 0.2% probability that these differences occurred by random chance alone. In the world of medical research, a p-value below 0.05 (5%) is generally considered significant, so these results are highly robust.
The 95% confidence intervals provide additional context. A confidence interval is a range of values within which the true effect likely falls. For example, the FRS difference of 1.07 with a 95% CI of 0.11 to 2.03 means that researchers are 95% confident that the true difference lies somewhere between 0.11 and 2.03 points. Since the entire interval is above zero, this provides strong evidence of a real effect.
Importantly, the study reported that FRS decreased from baseline in the intervention group (−0.58) while increasing in the control group (+0.35). The absolute difference between these changes is the 1.07-point group difference mentioned above. This demonstrates that the intervention didn't just slow down risk progression — it reversed it.
What This Means for Patients
These findings matter because they address one of the most frustrating problems in cardiovascular medicine: getting patients to genuinely engage with prevention. Previous research on visual feedback has produced mixed results. The EISNER trial, published in 2011, showed that coronary artery calcium scanning led to improvements in cardiovascular risk factors without increasing unnecessary downstream testing. A 2012 study by Rodondi and colleagues found that carotid plaque screening improved smoking cessation rates. However, these earlier studies were smaller or produced inconsistent findings.
The VIPVIZA trial is the first large, randomised controlled trial to show significant improvements in validated risk scores using ultrasound-based pictorial information. The practical takeaway is powerful: when patients see physical evidence of disease developing inside their own bodies, they may be more motivated to take their medications, quit smoking, lose weight, and improve their diets.
The study also demonstrated that the combination of visual information plus a nurse phone call was effective. This two-part approach — showing the image and then talking it through — appears to be key. The phone call ensured that patients understood the images and their implications, and it may have provided an opportunity for questions and reinforcement.
Another important message: seeing evidence of silent atherosclerosis is not a verdict — it's an opportunity. The disease detected in this study was subclinical, meaning it had not yet caused any symptoms. Detecting it early gives patients a crucial window of time to take action before a heart attack or stroke occurs.
Study Limitations
As with any study, the VIPVIZA trial has limitations that should be honestly acknowledged:
- Open-label design: Both participants and researchers knew which group participants were in. This can introduce bias in how participants report their behaviors or how researchers interpret outcomes, although the objective nature of the risk score measurements — based on blood tests, blood pressure readings, and other quantitative data — helps mitigate this concern.
- Single region: The study was conducted in northern Sweden, where the population is relatively homogeneous in terms of ethnicity and socioeconomic background. Results may not generalize to more diverse populations in other countries with different healthcare systems, cultural attitudes toward health, and risk factor profiles.
- Short follow-up: Outcomes were assessed at only 1 year. Longer-term follow-up is needed to determine whether the improvements in risk scores translate into actual reductions in heart attacks, strokes, and cardiovascular deaths over 5, 10, or even 20 years.
- Surrogate outcomes: The study measured risk scores (FRS and SCORE) rather than actual cardiovascular events. While these scores are validated predictors of future events, they are not the same as measuring whether participants actually had fewer heart attacks or strokes.
- Selective participation: The Västerbotten Intervention Programme invites all eligible residents to participate, but those who choose to enroll may be more health-conscious or motivated than the general population. This could affect how well the results apply to people who are less engaged with their health.
Recommendations for Patients and Doctors
Based on this study's findings, several practical recommendations emerge:
For Healthcare Providers
- When ultrasound or other imaging is performed, take the time to show the images to the patient and explain what they mean in clear, accessible language.
- Follow up with a phone call or extra conversation to confirm understanding and answer any questions.
- Use risk scores alongside visual evidence to motivate lifestyle changes and medication adherence — the combination appears to be more powerful than either approach alone.
For Patients
- If your doctor offers imaging to assess your cardiovascular risk, consider it seriously — the visual evidence may help you understand your risk in a way that numbers alone cannot.
- Ask your doctor to explain your imaging results in detail, and request to see the images if they are available.
- Remember that discovering silent atherosclerosis early is a gift: it gives you time to make changes that could prevent a life-altering event.
- If you receive concerning imaging results, don't panic — instead, work with your healthcare team to create a plan for medication, lifestyle changes, and regular follow-up.
For Health Systems
The findings support the development of programmes that integrate imaging into routine cardiovascular risk screening. The cost-effectiveness of such an approach warrants further investigation — a 2018 study by Lindholm and colleagues in BMC Public Health demonstrated that the broader Västerbotten community-based CVD programme was cost-effective, suggesting that adding pictorial feedback could be a worthwhile investment.
Frequently Asked Questions
Who was eligible to take part in this research?
Participants were 40, 50, or 60 years old and had at least one common cardiovascular risk factor, such as high blood pressure, high cholesterol, smoking, diabetes, or a family history of heart disease. They were enrolled in northern Sweden between 2013 and 2016, and 3,532 people joined the trial.
What did people in the intervention group actually receive?
They received a pictorial representation of their carotid ultrasound results, showing plaque buildup in their neck arteries. A nurse then phoned them to confirm they understood the findings. The control group was not informed of their ultrasound results. Both groups had clinical exams, blood sampling, and ultrasound assessments at the start.
What does the Framingham risk score measure?
The Framingham risk score estimates your 10-year risk of developing cardiovascular disease, including heart attacks, strokes, and other cardiovascular events. It was originally developed from the Framingham Heart Study, which began in 1948 in Framingham, Massachusetts. In this trial, it was one of two primary outcomes measured after one year.
What were the main results after one year?
After one year, the intervention group's Framingham risk score decreased by 0.58 points, while the control group's increased by 0.35 points. The difference between groups was 1.07 points. For the European SCORE, both groups' risk rose, but the intervention group's increase was roughly half that of the control group.
What does a p-value of 0.0017 mean?
A p-value of 0.0017 means there is less than a 0.2% probability that the difference occurred by random chance alone. In medical research, a p-value below 0.05 is generally considered significant, so this result is highly robust. The 95% confidence interval for the Framingham difference was 0.11 to 2.03 points.
What are the limitations of this trial?
The trial was open-label, so participants and researchers knew group assignments. It took place in one region of northern Sweden, so results may not apply to more diverse populations. Follow-up was only one year, and it measured risk scores rather than actual heart attacks or strokes. Participants may also have been more health-conscious than average.
What should I do if I receive concerning imaging results?
Don't panic. Discovering silent atherosclerosis early is an opportunity, not a verdict. Work with your healthcare team to create a plan for medication, lifestyle changes, and regular follow-up. Ask your doctor to explain your imaging results in detail and request to see the images if they are available.
If my carotid ultrasound shows plaque buildup, when should I get a second opinion before starting treatment?
A carotid ultrasound showing plaque means subclinical atherosclerosis is present, but no symptoms have appeared yet. Because the VIPVIZA trial measured risk scores rather than actual heart attacks and strokes, and followed patients for only one year, the long-term meaning of an individual scan can be uncertain. A second opinion can review whether the images were interpreted correctly and whether the proposed prevention plan fits your overall risk profile. Diagnostic Detectives Network provides independent expert second opinions.
Source Information
Original article title: AbstractVisualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) a pragmatic, open-label, randomised controlled trial - The Lancet
Authors: Prof Ulf Näslund, PhD; Prof Nawi Ng, PhD; Anna Lundgren, MD; Eva Fhärm, PhD; Christer Grönlund, PhD; Helene Johansson, PhD; et al.
Journal: The Lancet, Volume 393, Issue 10167, Pages 133–142, January 12, 2019
Published online: December 03, 2018
DOI: https://doi.org/10.1016/S0140-6736(18)32818-6
Trial registration: ClinicalTrials.gov, number NCT01849575
Funding sources: Västerbotten County Council, the Swedish Research Council, the Heart and Lung Foundation, the Swedish Society of Medicine, and Carl Bennet Ltd, Sweden.
This patient-friendly article is based on peer-reviewed research published in The Lancet. It is intended for educational purposes only and is not a substitute for professional medical advice. Always consult your healthcare provider about your individual cardiovascular risk and treatment options.