VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - The Swedish Prescribed Drug Register

SND-ID: 2020-204-10.

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Alternative title

VIPVIZA

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Bo Carlberg - Umeå University, Department of Public Health and Clinical Medicine

Maria Sjölander - Umeå University, Department of Integrative Medical Biology

Umeå University, Department of Public Health and Clinical Medicine

Research principal

Umeå University - Department of Public Health and Clinical Medicine rorId

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

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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

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Data contains personal data

Yes

Sensitive personal data

Yes

Type of personal data

Medical data at individual level

Code key exists

Yes

Language

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)

Description of study design

Pagmatic open-label, randomised controlled trial with masked evaluators (PROBE)

Sampling procedure

Other
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

2013-04-29 – Ongoing

Biobank is connected to the study

Yes

Data format / data structure

Data collection
  • Mode of collection: Registry extract and/or access to biobank sample
  • Time period(s) for data collection: 2011-01-02 – 2020-09-30
Geographic coverage

Geographic spread

Geographic location: Västerbotten County

Geographic description: Region Västerbotten

Highest geographic unit

Region

Administrative information

Responsible department/unit

Department of Public Health and Clinical Medicine

Contributor(s)

Wolfgang Lohr - Umeå University, Department of Epidemiology and Global HEalth

Funding 1

  • Funding agency: The Swedish Insurance Society

Funding 2

  • Funding agency: The Swedish Research Council
  • Funding agency's reference number: Dnr 521-2013-2708, 2016-01891, 2017-02246

Funding 3

  • Funding agency: Region Västerbotten
  • Funding agency's reference number: ALFVLL-298001, ALFVLL-643391

Funding 4

  • Funding agency: Visare Norr (the four Northern Regions)
  • Funding agency's reference number: 465621, 561591, 741711, 931135

Funding 5

  • Funding agency: Carl Bennet Ltd, Sweden
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Funding 1

  • Funding agency: The Swedish Insurance Society

Funding 2

  • Funding agency: The Swedish Research Council
  • Funding agency's reference number: Dnr 521-2013-2708, 2016-01891, 2017-02246

Funding 3

  • Funding agency: Region Västerbotten
  • Funding agency's reference number: ALFVLL-298001, ALFVLL-643391

Funding 4

  • Funding agency: Visare Norr (the four Northern Regions)
  • Funding agency's reference number: 465621, 561591, 741711, 931135

Funding 5

  • Funding agency: Carl Bennet Ltd, Sweden

Funding 6

  • Funding agency: Swedish Society of Medicine
  • Funding agency's reference number: 405351, 503111

Funding 7

  • Funding agency: SKANDIA Risk & Health

Funding 8

  • Funding agency: The Heart and Lung Foundation
  • Funding agency's reference number: Dnr 20150369, 20170481)

Funding 9

  • Funding agency: The Heart Foundation in Northern Sweden
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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

Topic and keywords

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)

Publications

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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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Related research data in SND's catalogue

Northern Sweden Diet Database (NSDD)

NSHDS-VIP

VIPVIZA - VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - VIP baseline (lifestyle)

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Lifestyle 1 year

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Clinical CVD risk factors and lifestyle habits 3 year

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Ultrasound baseline

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Ultrasound 3 year

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Psychological (Problem management) , baseline

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Psychological factors and reactions to the VIPVIZA intervention (Problem management), 3 years

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - VIP Historical data 10 years before baseline

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - VIP historical data 20 years before basline

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Military service mustering register

VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program - Data from Statistics Sweden

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