VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - VIP baseline (lifestyle)
The aim of the project is to develop better methods for prevention of cardiovascular diseases (CVD). It is based on the hypothesis that image-based information on subclinical atherosclerosis (i) increases the precision in the assessment of risk of CVD, (ii) improves communication and understanding of the risk, and as a consequence (iii) the motivation for and adherence to evidence-based pharmacological treatment and lifestyle modification will increase. In addition to conventional risk factor assessment and CVD prevention within the framework of Västerbotten Intervention Program.
3500 healthy participants with low/moderate risk of CVD underwent ultrasound examination of the carotid arteries and were randomized to two groups. In the intervention group, the participants and their doctors received pictorial and graphic information in color about the participant’s subclinical atherosclerosis. No information about the ultrasound results was given to the control group. Follow-up after 1, 3 and 6.5 years includes sampling regarding clinical risk factors, blood for biomarker analyses, extensive questionnaires and interviews.
At 3 and 6.5 years the ultrasound examination was repeated and all participants and their doctors were informed about the results. The database also includes register data regarding prescriptions of preventive medication, exposure data for air pollutants, data from health examinations within the VIP 10 and 20 years before VIPVIZA, and for men conscription data.
After 10 years, registry data on endpoints, CVD morbidity and mortality will be collected.
Access to VIPVIZA's data portal and research data from VIPVIZA is possible in collaboration with researchers within the VIPVIZA project. For further information, contact PI Ulf Näslund ulf.naslund@umu.seOpens in a new tab
Variables from participation in Västerbotten Intervention Programme (VIP) at baseline:
Clinincal risk factors for cardiovascular disease, and
Questionnaire data from VIP containing demography, socio-economy, health, medication regarding prevention of CVD, quality of life (RAND36), lide style habits, Social network (ISSI), work related stress (Karasek).
Citation and access
Citation and access
Data access level:
Creator/Principal investigator(s):
- Ulf Näslund - Umeå University - Public Health and Clinical Medicine
- Patrik Wennberg - Umeå University - Family Medicine
- Nawi Ng - University of Gothenburg - Institute of Medicine, Sahlgrenska Academy
- Johan Hultdin - Umeå University - Department of Medical Biosciences
Research principal:
Data contains personal data:
Yes
Type of personal data:
Medical data at individual level
Code key exists:
Yes
Sensitive personal data:
Yes
Citation:
Language:
Method and outcome
Method and outcome
Unit of analysis:
Population:
Healthy subjects aged 40-60 years at low/moderate risk of cardiovascular disease
Study design:
- Randomised controlled trial (RCT)
- Experimental study
Description of study design:
Pagmatic open-label, randomised controlled trial with masked evaluators (PROBE)
Sampling procedure:
Description of sampling:
Subjects having at least one cardiovascular risk factor at the occasion of participation in the Västerbotten INtervention Programme: 1) age 40 years and a first-degree relative with a history oc cardiovascular disease at an age younger than 60 years, abdominal obesity, hypertension, diabetes, LDL-cholesterol >= 4.5 mmol/l, smoking. 3) Age 60 years. Exclusion criterion: More than 50% narrowing of the lumen of carotid areteries
Time period(s) investigated:
Variables:
444
Number of individuals/objects:
3532
Response rate/participation rate:
100%
Data format/data structure:
Data collection - Registry extract and/or access to biobank sample
Data collection - Registry extract and/or access to biobank sample
Mode of collection:
Registry extract and/or access to biobank sample
Time period(s) for data collection:
2012-04-11 - 2016-06-01
Source of the data:
- Registers/Records/Accounts
Geographic coverage
Geographic coverage
Geographic location:
Geographic description:
Region Västerbotten
Highest geographic unit:
Region
Administrative information
Administrative information
Responsible department/unit:
Department of Public Health and Clinical Medicine
Contributor(s):
- Wolfgang Lohr - Umeå University - Department of Epidemiology and Global HEalth
Ethics Review:
Swedish Ethical Review Authority - Dnr 2011-441-31M. Amendments:Dnr 2012-463-32M, Dnr 2013-373-32M, Dnr 2016-245-32M, Dnr 2017-95-32M, Dnr 2018-182-32, Dnr 2018-482-32M, Dnr 2019-0691, Dnr Ö 23-2020/3.1
Funding
Funding
Funding agency:
- Region Västerbotten
Award number:
ALFVLL-298001, ALFVLL-643391
Funding agency:
- Carl Bennet Ltd, Sweden
Funding agency:
- Swedish Society of Medicine
Award number:
405351, 503111
Funding agency:
- SKANDIA Risk & Health
Funding agency:
- The Heart and Lung Foundation
Award number:
Dnr 20150369, 20170481)
Funding agency:
- The Swedish Research Council
Award number:
Dnr 521-2013-2708, 2016-01891, 2017-02246
Funding agency:
- The Swedish Insurance Society
Funding agency:
- The Heart Foundation in Northern Sweden
Funding agency:
- Visare Norr (the four Northern Regions)
Award number:
465621, 561591, 741711, 931135
Topic and keywords
Topic and keywords
Standard för svensk indelning av forskningsämnen 2025:
Relations
Relations
Publications
Publications
Citation:
Bengtsson, A., Norberg, M., Ng, N., Carlberg, B., Grönlund, C., Hultdin, J., ... & Näslund, U. (2021). The beneficial effect over 3 years by pictorial information to patients and their physician about subclinical atherosclerosis and cardiovascular risk: Results from the VIPVIZA randomized clinical trial. American Journal of Preventive Cardiology, 7, 100199.
Citation:
Vanoli, D. (2017). Vascular ultrasound for the assessment of carotid atherosclerosis [PhD dissertation, Umeå University]. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-139538Opens in a new tab
ISBN:
978-91-7601-748-7
Citation:
Vanoli, D., Lindqvist, P., Wiklund, U., Henein, M., & Näslund, U. (2013). Fully automated on-screen carotid intima-media thickness measurement : a screening tool for subclinical atherosclerosis. Journal of Clinical Ultrasound, 41(6), 333–339. https://doi.org/10.1002/jcu.22041Opens in a new tab
Citation:
Bengtsson, A., Lindvall, K., Norberg, M., & Fhärm, E. (2021). Increased knowledge makes a difference!–general practitioners’ experiences of pictorial information about subclinical atherosclerosis for primary prevention: an interview study from the VIPVIZA trial. Scandinavian Journal of Primary Health Care, 39(1), 77-84.
Citation:
Vanoli, D., Wiklund, U., Lindqvist, P., Henein, M., & Näslund, U. (2014). Successful novice’s training in obtaining accurate assessment of carotid IMT using an automated ultrasound system. European Heart Journal Cardiovascular Imaging, 15(6), 637–642. https://doi.org/10.1093/ehjci/jet254Opens in a new tab
Citation:
Lindahl, B., Norberg, M., Johansson, H., Lindvall, K., Ng, N., Nordin, M., Nordin, S., Näslund, U., Persson, A., Vanoli, D., & Schulz, P. J. (2020). Health literacy is independently and inversely associated with carotid artery plaques and cardiovascular risk. European Journal of Preventive Cardiology, 27(2), 209–215. https://doi.org/10.1177/2047487319882821Opens in a new tab
Citation:
Nyman, E., Vanoli, D., Näslund, U., & Grönlund, C. (2020). Inter-sonographer reproducibility of carotid ultrasound plaque detection using Mannheim consensus in subclinical atherosclerosis. Clinical Physiology and Functional Imaging, 40(1), 46–51. https://doi.org/10.1111/cpf.12602Opens in a new tab
Citation:
Näslund, U., Ng, N., Lundgren, A., Fhärm, E., Grönlund, C., Johansson, H., Lindahl, B., Lindahl, B., Lindvall, K., Nilsson, S. K., Nordin, M., Nordin, S., Nyman, E., Rocklöv, J., Vanoli, D., Weinehall, L., Wennberg, P., Wester, P., & Norberg, M. (2019). Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) : a pragmatic, open-label, randomised controlled trial. The Lancet, 393(10167), 133–142. https://doi.org/10.1016/S0140-6736(18)32818-6Opens in a new tab
Citation:
Nyman, E., Lindqvist, P., Näslund, U., & Grönlund, C. (2018). Risk Marker Variability in Subclinical Carotid Plaques Based on Ultrasound is Influenced by Cardiac Phase, Echogenicity and Size. Ultrasound in medicine & biology, 44(8), 1742–1750.
