VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Ultrasound 3 year
SND-ID: 2020-204-7.
Alternative title
VIPVIZA
Creator/Principal investigator(s)
Ulf Näslund - Umeå University, Public Health and Clinical Medicine
Christer Grönlund - Umeå University, Department of Radiation Sciences
Per Wester - Umeå University, Public Health and Clinical medicine
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
Carotid ultrasound examination with Intima Media Thickness (IMT) measured in several insonation angles according to a standardized protocol and detection of plaques, as well as information to the intervention group regarding vascular age and presence of plaques 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
2013-04-29 – Ongoing
Biobank is connected to the study
Yes
Variables
37
Number of individuals/objects
3154
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
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