VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Data from Statistics Sweden
SND-ID: 2020-204-14.
Alternative title
VIPVIZA
Creator/Principal investigator(s)
Margareta Norberg
- Umeå University, Department of Epidemiology and Global Health
Steven Nordin - Umeå University, Department of Psychology
Umeå University, Department of Public Health and Clinical Medicine
Research principal
Umeå University
- Department of Public Health and Clinical Medicine
Description
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 quest
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
Highest attain educational level and Disposable income Show less..
Data contains personal data
Yes
Sensitive personal data
Yes
Type of personal data
Medical data at individual level
Code key exists
Yes
Language
Unit of analysis
Population
Healthy subjects aged 40-60 years at low/moderate risk of cardiovascular disease
Study design
Randomised controlled trial (RCT)
Description of study design
Pagmatic open-label, randomised controlled trial with masked evaluators (PROBE)
Sampling procedure
Exclusion criterion: More than 50% narrowing of the lumen of carotid areteries
Time period(s) investigated
2011 – 2018
Biobank is connected to the study
Yes
Variables
13
Data format / data structure
Geographic spread
Geographic location: Västerbotten County
Geographic description: Region Västerbotten
Highest geographic unit
Region
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 - Ref. 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
Research area
Cardiac and cardiovascular systems (Standard för svensk indelning av forskningsämnen 2011)
Radiology, nuclear medicine and medical imaging (Standard för svensk indelning av forskningsämnen 2011)
Clinical laboratory medicine (Standard för svensk indelning av forskningsämnen 2011)
General practice (Standard för svensk indelning av forskningsämnen 2011)
Public health, global health, social medicine and epidemiology (Standard för svensk indelning av forskningsämnen 2011)
Medical biotechnology (focus on cell biology (incl. stem cell biology), molecular biology, microbiology, biochemistry or biopharmacy) (Standard för svensk indelning av forskningsämnen 2011)
Psychology (Standard för svensk indelning av forskningsämnen 2011)
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.
DOI:
https://doi.org/10.1016/j.ajpc.2021.100199
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-139538
ISBN:
978-91-7601-748-7
URN:
urn:nbn:se:umu:diva-139538
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.22041
URN:
urn:nbn:se:umu:diva-78429
DOI:
https://doi.org/10.1002/jcu.22041
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.
DOI:
https://doi.org/10.1080/02813432.2021.1882083.
URN:
urn:nbn:se:umu:diva-78429
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/jet254
DOI:
https://doi.org/10.1093/ehjci/jet254
URN:
urn:nbn:se:umu:diva-91057
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/10.1177/2047487319882821
DOI:
https://doi.org/10.1177/2047487319882821
URN:
urn:nbn:se:umu:diva-165791
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.12602
DOI:
https://doi.org/10.1111/cpf.12602
URN:
urn:nbn:se:umu:diva-165443
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)32818-6
DOI:
https://doi.org/10.1016/S0140-6736(18)32818-6
URN:
urn:nbn:se:umu:diva-154318
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.
DOI:
https://doi.org/10.1016/j.ultrasmedbio.2018.03.013
Sjolander M, Carlberg B, Norberg M, Naslund U, Ng N. 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.
DOI:
https://doi.org/10.1001/jamanetworkopen.2021.21683
Schulz PJ, Lindahl B, Hartung U, Naslund U, Norberg M, Nordin S. The right pick: Does a self-assessment measurement tool correctly identify health care consumers with inadequate health literacy? Patient Educ Couns. 2022;105(4):926-32.
DOI:
https://doi.org/10.1016/j.pec.2021.100144
Kovrov O*, Landfors F*, Saar-Kovrov V, Naslund U, Olivecrona G. Lipoprotein size is a main determinant for the rate of hydrolysis by exogenous LPL in human plasma. J Lipid Res 2022;63:100144
* shared first authorship
DOI:
https://doi.org/10.1016/j.jlr.2021.100144
Holmberg H, Sjölander M, Glader E-L, Näslund U, Carlberg C, Själander A. Time to initiation of lipid-lowering drugs for subclinical atherosclerosis. Sub study of VIPVIZA randomized controlled trial, with single arm cross-over. European Heart Journal Open 2022; 00:1-6.
DOI:
https://doi.org/10.1093/ehjopen/oeac003
Sommar JN, Norberg M, Gronlund C, Segersson D, Naslund U, Forsberg B. Long-term exposure to particulate air pollution and presence and progression of carotid artery plaques - A northern Sweden VIPVIZA cohort study. Environmental research 2022:113061.
DOI:
https://doi.org/10.1016/j.envres.2022.113061
Rohlen R, Jiang B, Nyman E, Wester P, Näslund U, Grönlund C. Inter-frame echo intensity variation of subregions and whole plaque in 2-D carotid ultrasonography – Simulations and in-vivo observations. J Ultrasound in Medicine 2022 Oct 20
DOI:
https://doi.org/10.1002/jum.16114
Nyman E, Liv P, Wester P, Naslund U, Gronlund C. Carotid wall echogenicity at baseline associates with accelerated vascular aging in a middle-aged population. The international journal of cardiovascular imaging 2023.
DOI:
https://doi.org/10.1007/s10554-022-02760-3
Nyman E, Gronlund C, Vanoli D et al. Reduced progression of carotid intima media thickness by personalised pictorial presentation of subclinical atherosclerosis in VIPVIZA-A randomised controlled trial. Clin Physiol Funct Imaging 2023.
DOI:
https://doi.org/10.1111/cpf.12811
Andersson EM, Johansson H, Nordin S, Lindvall K. Cognitive and emotional reactions to pictorial-based risk communication on subclinical atherosclerosis: a qualitative study within the VIPVIZA trial. Scand J Prim Health Care 2023:1-12.
DOI:
https://doi.org/10.1080/02813432.2023.2178850
Fortuin-de Smidt M, Bergman F, Gronlund C et al. Early adulthood exercise capacity, but not muscle strength, associates with subclinical atherosclerosis 40 years later in Swedish men. Eur J Prev Cardiol 2023;30:407-415.
DOI:
https://doi.org/10.1093/eurjpc/zwad007
Ali H, Näslund U, Nyman E, Grönlund C. Translation of atherosclerotic disease features onto healthy carotid ultrasound images using domain-to-domain translation. Biomedical Signal Processing and Control 85 (2023) 104886
DOI:
https://doi.org/10.1016/j.bspc.2023.104886
Bengtsson A, Nyman E, Gronlund C, Wester P, Naslund U, Fharm E, et al. 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. Int J Cardiovasc Imaging. 2023;39(8):1461-71
DOI:
https://doi.org/10.1007/s10554-023-02868-0
Nordin S, Norberg M, Braf I, Johansson H, Lindahl B, Lindvall K, et al. Associations between emotional support and cardiovascular risk factors and subclinical atherosclerosis in middle-age. Psychol Health. 2023:1-15.
DOI:
https://doi.org/10.1080/08870446.2023.2286296
Salvador D, Jr., Liv P, Norberg M, Pahud de Mortanges A, Saner H, Glisic M, et al. Changes in fasting plasma glucose and subclinical atherosclerosis: A cohort study from VIPVIZA trial. Atherosclerosis. 2023:117326
DOI:
https://doi.org/10.1016/j.atherosclerosis.2023.117326
Andersson EM, Liv P, Nordin S, Naslund U, Lindvall K. Does a multi-component intervention including pictorial risk communication about subclinical atherosclerosis improve perceptions of cardiovascular disease risk without deteriorating efficacy beliefs? Soc Sci Med. 2024;341:116530.
DOI:
https://doi.org/10.1016/j.socscimed.2023.116530
Andersson EM, Lindvall K, Wennberg P, Johansson H, Nordin S. From risk communication about asymptomatic atherosclerosis to cognitive and emotional reactions and lifestyle modification. BMC Psychol. 2024;12(1):47
DOI:
https://doi.org/10.1186/s40359-023-01467-x
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