VIPVIZA - VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program
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.se
Documentation files
Documentation files
Citation and access
Citation and access
Creator/Principal investigator(s):
- Ulf Näslund - Umeå University - Public Health and Clinical Medicine
- Patrik Wennberg - Umeå University - Family Medicine
- Umeå University - Department of Public Health and Clinical Medicine
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:
Data access level:
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:
Number of individuals/objects:
3532
Data format/data structure:
Data collections - 15 collections
Data collections - 15 collections
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
Description of the mode of collection:
VIP historical data 20 years before basline
Time period(s) for data collection:
1992 - 1998
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
Description of the mode of collection:
VIP Historical data 10 years before baseline
Time period(s) for data collection:
2000 - 2009
Source of the data:
- Registers/Records/Accounts
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
Description of the mode of collection:
The Swedish Prescribed Drug Register
Time period(s) for data collection:
2011-01-02 - 2020-09-30
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
Description of the mode of collection:
VIP baseline (lifestyle)
Time period(s) for data collection:
2012-04-11 - 2016-06-01
Source of the data:
- Registers/Records/Accounts
Data collection - Physical measurements and tests
Data collection - Physical measurements and tests
Mode of collection:
Physical measurements and tests
Description of the mode of collection:
Ultrasound baseline
Time period(s) for data collection:
2013-04-27 - 2016-06-07
Source of the data:
- Research data
Instrument
Instrument
Name:
Description of the instrument:
CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA - A portable ultrasound system with a linear 7MHz transducer, Ultrasound 2D, B-mode settings including depth, gain and focus point were optimized for each participant manually by the sonographer. CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Psychological (Problem management) , baseline
Time period(s) for data collection:
2013-04-29 - 2016-06-07
Source of the data:
- Research data
Instrument
Instrument
Name:
GSE, General Self-Efficacy Scale
Description of the instrument:
Self-report measure of general self-efficacy, an individual's belief in his or her capacity to execute behaviors necessary to produce performance attainments
Name:
LOT-R Life Orientation Test-Revised
Description of the instrument:
Self-report instrument that assesses one’s dispositional level of optimism/pessimism
Name:
HADS Hpiostal Anxiety and Depression Scale
Description of the instrument:
Self-assessment form for anxiety (subscale HADS-anxiety, 7 questions) and depression (subscale HADS-depression, 7 questions)
Name:
Description of the instrument:
Self-rated risk of CVD - VAS-scale
Name:
Brief Health Literacy Screen (BHLS)
Description of the instrument:
Three questions on self-rated health literacy according to Chew
Name:
Brief Cope
Description of the instrument:
Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Lifestyle 1 year
Time period(s) for data collection:
2014-05-08 - 2017-11-01
Source of the data:
- Research data
Data collection - Biological tests
Data collection - Biological tests
Mode of collection:
Biological tests
Description of the mode of collection:
Lifestyle 1 year
Time period(s) for data collection:
2014-05-08 - 2017-11-01
Data collector:
- Umeå University
Opens a new window at ror.org.
ROROpens in a new tab
Source of the data:
- Research data
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Clinical CVD risk factors and lifestyle habits 3 year
Time period(s) for data collection:
2016-01-14 - 2019-06-14
Data collection - Measurements and tests
Data collection - Measurements and tests
Mode of collection:
Measurements and tests
Description of the mode of collection:
Clinical CVD risk factors and lifestyle habits 3 year
Time period(s) for data collection:
2016-01-16 - 2019-06-14
Data collection - Physical measurements and tests
Data collection - Physical measurements and tests
Mode of collection:
Physical measurements and tests
Description of the mode of collection:
Ultrasound 3 year
Time period(s) for data collection:
2016-09-05 - 2019-05-28
Source of the data:
- Research data
Instrument
Instrument
Name:
Description of the instrument:
CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA - A portable ultrasound system with a linear 7MHz transducer, Ultrasound 2D, B-mode settings including depth, gain and focus point were optimized for each participant manually by the sonographer. CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Psykologiska faktorer och reaktioner på VIPVIZA interventionen (Problemhantering), efter 3 år
Time period(s) for data collection:
2016-09-05 - 2019-05-28
Instrument
Instrument
Name:
GSE General Self Efficacy Scale
Description of the instrument:
Self-report measure of general self-efficacy, an individual's belief in his or her capacity to execute behaviors necessary to produce performance attainments
Name:
LOT-R Life Orientation Test - Revised
Description of the instrument:
Self-report instrument that assesses one’s dispositional level of optimism/pessimism
Name:
Brief Cope
Description of the instrument:
Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
Name:
Description of the instrument:
Specific VIPVIZA questionnaire - Self-rated risk of CVDm Specific self-efficacy, attitudes and norms related to life style habits. To the intervention group: Emotional and cognitive reactions and impact of the intervention
Name:
BHLS Brief Health Literacy Screen
Description of the instrument:
Three questions on self-rated health literacy, according to Chew
Name:
HADS Hospital Anxiety Depression Scale
Description of the instrument:
Self-assessment form for anxiety (subscale HADS-anxiety, 7 questions) and depression (subscale HADS-depression, 7 questions)
Name:
SMBQ Shirom-Melamed Burnout Questionnaire
Description of the instrument:
Questionnaire to evaluate burnout
Data collection
Data collection
Description of the mode of collection:
Included study participants
Time period(s) for data collection:
2017-01-19 - 2017-01-19
Source of the data:
- Research data
Instrument
Instrument
Name:
Case Report Form
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
Description of the mode of collection:
Military service mustering register
Data collector:
- Riksarkivet
Source of the data:
- Registers/Records/Accounts
Data collection - Biological tests
Data collection - Biological tests
Mode of collection:
Biological tests
Description of the mode of collection:
Included study participants
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:
- Carl Bennet Ltd, Sweden
Funding agency:
- The Swedish Insurance Society
Funding agency:
- The Heart Foundation in Northern Sweden
Funding agency:
- Swedish Society of Medicine
Funding agency's reference number:
405351, 503111
Funding agency:
- Visare Norr (the four Northern Regions)
Funding agency's reference number:
465621, 561591, 741711, 931135
Funding agency:
- The Swedish Research Council
Funding agency's reference number:
Dnr 521-2013-2708, 2016-01891, 2017-02246
Funding agency:
- Region Västerbotten
Funding agency's reference number:
ALFVLL-298001, ALFVLL-643391
Funding agency:
- The Heart and Lung Foundation
Funding agency's reference number:
Dnr 20150369, 20170481)
Funding agency:
- SKANDIA Risk & Health
Topic and keywords
Topic and keywords
Standard för svensk indelning av forskningsämnen 2011:
Relations
Relations
Homepage:
Related research data:
Publications
Publications
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:
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(18Opens in a new tab)32818-6
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. In Ultrasound in Medicine and Biology (Vol. 44, Issue 8, pp. 1742–1750). https://doi.org/10.1016/j.ultrasmedbio.2018.03.013Opens in a new tab
Citation:
Sjölander, M., Carlberg, B., Norberg, M., Näslund, U., & Ng, N. (n.d.). Prescription of Lipid-Lowering and Antihypertensive Drugs Following Pictorial Information About Subclinical Atherosclerosis A Secondary Outcome of a Randomized Clinical Trial. JAMA Netw Open. 2021;4(8):e2121683. https://doi.org/10.1001/jamanetworkopen.2021.21683Opens 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. https://doi.org/10.1080/02813432.2021.1882083Opens in a new tab
Citation:
Rohlén, R., Jiang, B., Nyman, E., Wester, P., Näslund, U. and Grönlund, C. (2023), Interframe Echo Intensity Variation of Subregions and Whole Plaque in Two-Dimensional Carotid Ultrasonography. J Ultrasound Med, 42: 1033-1046. https://doi.org/10.1002/jum.16114Opens in a new tab
Citation:
Nilsson Sommar, J., Norberg, M., Grönlund, C., Segersson, D., Näslund, U., & Forsberg, B. (2022). Long-term exposure to particulate air pollution and presence and progression of carotid artery plaques : A northern Sweden VIPVIZA cohort study. In Environmental Research (No. 113061; Vol. 211). https://doi.org/10.1016/j.envres.2022.113061Opens in a new tab
Citation:
Bengtsson, A., Norberg, M., Ng, N., Carlberg, B., Grönlund, C., Hultdin, J., Lindahl, B., Lindahl, B., Nordin, S., Nyman, E., Wennberg, P., Wester, P., & 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. In American Journal of Preventive Cardiology (No. 100199; Vol. 7). https://doi.org/10.1016/j.ajpc.2021.100199Opens in a new tab
Citation:
Holmberg, H., Sjölander, M., Glader, E.-L., Näslund, U., Carlberg, B., Norberg, M., & Själander, A. (2022). Time to initiation of lipid-lowering drugs for subclinical atherosclerosis : sub-study of VIPVIZA randomized controlled trial, with single-arm cross-over. In European Heart Journal Open (No. oeac003; Vol. 2, Issue 1). https://doi.org/10.1093/ehjopen/oeac003Opens in a new tab
Citation:
Kovrov, O., Landfors, F., Saar-Kovrov, V., Näslund, U., & Olivecrona, G. (2022). Lipoprotein size is a main determinant for the rate of hydrolysis by exogenous LPL in human plasma. In Journal of Lipid Research (No. 100144; Vol. 63, Issue 1). https://doi.org/10.1016/j.jlr.2021.100144Opens in a new tab
Citation:
Schulz, P. J., Lindahl, B., Hartung, U., Näslund, U., Norberg, M., & Nordin, S. (2022). The right pick : Does a self-assessment measurement tool correctly identify health care consumers with inadequate health literacy? In Patient Education and Counseling (Vol. 105, Issue 4, pp. 926–932). https://doi.org/10.1016/j.pec.2021.07.045Opens in a new tab
Citation:
Andersson, E. M., Liv, P., Nordin, S., Näslund, U., & Lindvall, K. (2024). Does a multi-component intervention including pictorial risk communication about subclinical atherosclerosis improve perceptions of cardiovascular disease risk without deteriorating efficacy beliefs? In Social Science and Medicine (No. 116530; Vol. 341). https://doi.org/10.1016/j.socscimed.2023.116530Opens in a new tab
Citation:
Salvador, D., Liv, P., Norberg, M., Pahud de Mortanges, A., Saner, H., Glisic, M., Nicoll, R., Muka, T., Nyman, E., Bano, A., & Näslund, U. (2023). Changes in fasting plasma glucose and subclinical atherosclerosis : a cohort study from VIPVIZA trial. In Atherosclerosis. https://doi.org/10.1016/j.atherosclerosis.2023.117326Opens in a new tab
Citation:
Nordin, S., Norberg, M., Braf, I., Johansson, H., Lindahl, B., Lindvall, K., Nordin, M., Nyman, E., Vallström, C., Wennberg, P., Liv, P., & Näslund, U. (2023). Associations between emotional support and cardiovascular risk factors and subclinical atherosclerosis in middle-age. In Psychology and Health. https://doi.org/10.1080/08870446.2023.2286296Opens in a new tab
Citation:
Bengtsson, A., Nyman, E., Grönlund, C., Wester, P., Näslund, U., Fhärm, E., & Norberg, M. (2023). Multi-view carotid ultrasound is stronger associated with cardiovascular risk factors than presence of plaque or single carotid intima media thickness measurements in subclinical atherosclerosis. In The International Journal of Cardiovascular Imaging (Vol. 39, Issue 8, pp. 1461–1471). https://doi.org/10.1007/s10554-023-02868-0Opens in a new tab
Citation:
Ali, H., Nyman, E., Näslund, U., & Grönlund, C. (2023). Translation of atherosclerotic disease features onto healthy carotid ultrasound images using domain-to-domain translation. In Biomedical Signal Processing and Control (No. 104886; Vol. 85). https://doi.org/10.1016/j.bspc.2023.104886Opens in a new tab
Citation:
Fortuin-de Smidt, M., Bergman, F., Grönlund, C., Hult, A., Norberg, M., Wennberg, M., & Wennberg, P. (2023). Early adulthood exercise capacity, but not muscle strength, associates with subclinical atherosclerosis 40 years later in Swedish men. In European Journal of Preventive Cardiology (Vol. 30, Issue 5, pp. 407–415). https://doi.org/10.1093/eurjpc/zwad007Opens in a new tab
Citation:
Andersson, E. M., Johansson, H., Nordin, S., & Lindvall, K. (2022). Cognitive and emotional reactions to pictorial-based risk communication on subclinical atherosclerosis : a qualitative study within the VIPVIZA trial. In Scandinavian Journal of Primary Health Care (Vol. 41, Issue 1, pp. 69–80). https://doi.org/10.1080/02813432.2023.2178850Opens in a new tab
Citation:
Nyman, E., Grönlund, C., Vanoli, D., Liv, P., Norberg, M., Bengtsson, A., Wennberg, P., Wester, P., & Näslund, U. (2023). Reduced progression of carotid intima media thickness by personalised pictorial presentation of subclinical atherosclerosis in VIPVIZA : A randomised controlled trial. In Clinical Physiology and Functional Imaging (Vol. 43, Issue 4, pp. 232–241). https://doi.org/10.1111/cpf.12811Opens in a new tab
Citation:
Nyman, E., Liv, P., Wester, P., Näslund, U., & Grönlund, C. (2023). Carotid wall echogenicity at baseline associates with accelerated vascular aging in a middle-aged population. In The International Journal of Cardiovascular Imaging (Vol. 39, Issue 3, pp. 575–583). https://doi.org/10.1007/s10554-022-02760-3Opens in a new tab
Citation:
Andersson, E. M., Lindvall, K., Wennberg, P., Johansson, H., & Nordin, S. (2024). From risk communication about asymptomatic atherosclerosis to cognitive and emotional reactions and lifestyle modification. In BMC Psychology (No. 47; Vol. 12, Issue 1). https://doi.org/10.1186/s40359-023-01467-xOpens in a new tab
