Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention

NCT01849575 | Active Not Recruiting Results DMC

• 1 other identifier: VIPVIZA version 20121204
• Study Type: interventional
• Target: 3,532
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of VIPVIZA is to assess the impact of pictorial information about asymptomatic atherosclerotic disease to both physician and patient, for improving physicians' adherence to prevention guidelines and patient perception and understanding of the cardiovascular disease (CVD) risk and consequent motivation for prevention. The intervention effect is assessed by differences between randomization groups in the primaryboutcome Framingham Risk Score (FRS) and the secondary outcomes the Systematic COronary Risk Evaluation (SCORE) as well as changes in these scores after one, three and six years. Secondary outcomes are also atherosclerotic disease progression, as assessed by repeated carotid ultrasound examination after three and six years, as well as the prevalence of acute events and mortality after 10 years . Social, psychological and cognitive determinants of behavioral change as well as the intervention impact on novel biomarkers will also be explored.

Conditions

Cardiovascular Diseases

Keywords

Ultrasonography; Cardiovascular diseases; Prevention; Risk communication; Risk assessment; Behavioral change

Outcome Measures

Primary Outcomes (1)

• FRS

  Framingham risk score. Composite gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual, based on levels of blood pressure, total cholesterol, LDL-cholesterol, systolic blood pressure, treatment for high blood pressure, diabetes, smoking and age. Minimum value=0, maximum value 100. Higher score means a worse outcome, i.e. a higher risk of cardiovascular diseases.

  one year

Secondary Outcomes (5)

• SCORE

  Follow-up after one year

• Hospitalizations Due to Stroke, Myocardial Infarctions and Re-vascularizations

  10 years

• Total Mortality and Cause-specific Mortality Due to Myocardial Infarctions and Stroke

  10 years

• Total Mortality

  10 years

• Carotid Atherosclerosis

  3 years after baseline

Other Outcomes (2)

• FRS, Adjusted for Baseline Values

  Follow-up after three years during September 5 2016 - May 28 2019

• SCORE Adjusted for Baseline Levels

  Three years of follow-up, data collected during September 5 2016 - May 28 2019

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease

Behavioral: Intervention

Control

NO INTERVENTION

The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors

Interventions

Intervention BEHAVIORAL

Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.

Also known as: Information about ultrasound results

Intervention

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Participant in the Västerbotten Intervention Programme
• and
• years old and a history of CVD at age \< 60 years among first-degree relative
• years old and at least one of the following six criteria:
• a history of CVD at age \< 60 years among first-degree relative,
• smoking,
• diabetes,
• hypertension,
• S-LDL-cholesterol ≥4.5 mmol/L,
• abdominal obesity
• years old

You may not qualify if:

• Stenosis ≥50% of the carotid lumen

Sponsors & Collaborators

• Umeå University: lead
• Västerbotten County Council, Sweden: collaborator

Study Sites (1)

Clinical Reseach Center Umeå University Hospital

Umeå, Se-90185, Sweden

Location

Related Publications (26)

• Vanoli D, Lindqvist P, Wiklund U, Henein M, Naslund U. Fully automated on-screen carotid intima-media thickness measurement: a screening tool for subclinical atherosclerosis. J Clin Ultrasound. 2013 Jul-Aug;41(6):333-9. doi: 10.1002/jcu.22041. Epub 2013 Mar 28.

  PMID: 23553729 RESULT

• Vanoli D, Wiklund U, Lindqvist P, Henein M, Naslund U. Successful novice's training in obtaining accurate assessment of carotid IMT using an automated ultrasound system. Eur Heart J Cardiovasc Imaging. 2014 Jun;15(6):637-42. doi: 10.1093/ehjci/jet254. Epub 2013 Dec 29.

  PMID: 24378482 RESULT

• Nyman E, Lindqvist P, Naslund U, Gronlund C. Risk Marker Variability in Subclinical Carotid Plaques Based on Ultrasound is Influenced by Cardiac Phase, Echogenicity and Size. Ultrasound Med Biol. 2018 Aug;44(8):1742-1750. doi: 10.1016/j.ultrasmedbio.2018.03.013. Epub 2018 May 4.

  PMID: 29735317 RESULT

• Naslund U, Ng N, Lundgren A, Fharm E, Gronlund C, Johansson H, Lindahl B, Lindahl B, Lindvall K, Nilsson SK, Nordin M, Nordin S, Nyman E, Rocklov J, Vanoli D, Weinehall L, Wennberg P, Wester P, Norberg M; VIPVIZA trial group. Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial. Lancet. 2019 Jan 12;393(10167):133-142. doi: 10.1016/S0140-6736(18)32818-6. Epub 2018 Dec 3.

  PMID: 30522919 RESULT

• Nyman E, Vanoli D, Naslund U, Gronlund C. Inter-sonographer reproducibility of carotid ultrasound plaque detection using Mannheim consensus in subclinical atherosclerosis. Clin Physiol Funct Imaging. 2020 Jan;40(1):46-51. doi: 10.1111/cpf.12602. Epub 2019 Oct 29.

  PMID: 31605665 RESULT

• Lindahl B, Norberg M, Johansson H, Lindvall K, Ng N, Nordin M, Nordin S, Naslund U, Persson A, Vanoli D, Schulz PJ. Health literacy is independently and inversely associated with carotid artery plaques and cardiovascular risk. Eur J Prev Cardiol. 2020 Jan;27(2):209-215. doi: 10.1177/2047487319882821. Epub 2019 Oct 15.

  PMID: 31615294 RESULT

• Bengtsson A, Lindvall K, Norberg M, Fharm E. Increased knowledge makes a difference! - general practitioners' experiences of pictorial information about subclinical atherosclerosis for primary prevention: an interview study from the VIPVIZA trial. Scand J Prim Health Care. 2021 Mar;39(1):77-84. doi: 10.1080/02813432.2021.1882083. Epub 2021 Feb 11.

  PMID: 33569981 RESULT

• 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 Aug 2;4(8):e2121683. doi: 10.1001/jamanetworkopen.2021.21683.

  PMID: 34410393 RESULT

• 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 Apr;105(4):926-932. doi: 10.1016/j.pec.2021.07.045. Epub 2021 Jul 29.

  PMID: 34366227 RESULT

• 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 Jan;63(1):100144. doi: 10.1016/j.jlr.2021.100144. Epub 2021 Oct 26.

  PMID: 34710432 RESULT

• Holmberg H, Sjolander M, Glader EL, Naslund U, Carlberg B, Norberg M, Sjalander A. Time to initiation of lipid-lowering drugs for subclinical atherosclerosis: sub-study of VIPVIZA randomized controlled trial, with single-arm cross-over. Eur Heart J Open. 2022 Feb 4;2(1):oeac003. doi: 10.1093/ehjopen/oeac003. eCollection 2022 Jan.

  PMID: 35919662 RESULT

• 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. Environ Res. 2022 Aug;211:113061. doi: 10.1016/j.envres.2022.113061. Epub 2022 Mar 4.

  PMID: 35257687 RESULT

• 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. Int J Cardiovasc Imaging. 2023 Mar;39(3):575-583. doi: 10.1007/s10554-022-02760-3. Epub 2023 Jan 21.

  PMID: 36680684 RESULT

• Nyman E, Gronlund C, Vanoli D, Liv P, Norberg M, Bengtsson A, Wennberg P, Wester P, Naslund U; VIPVIZA trial group. 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 Jul;43(4):232-241. doi: 10.1111/cpf.12811. Epub 2023 Jan 27.

  PMID: 36642849 RESULT

• 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 Mar;41(1):69-80. doi: 10.1080/02813432.2023.2178850. Epub 2023 Feb 28.

  PMID: 36855328 RESULT

• Naslund U, Norberg M, Wennberg P. The TANSNIP-PESA trial is not the end of the story. Eur Heart J. 2023 May 1;44(17):1574. doi: 10.1093/eurheartj/ehad135. No abstract available.

  PMID: 36951199 RESULT

• Fortuin-de Smidt M, Bergman F, Gronlund C, Hult A, Norberg M, Wennberg M, Wennberg P. Early adulthood exercise capacity, but not muscle strength, associates with subclinical atherosclerosis 40 years later in Swedish men. Eur J Prev Cardiol. 2023 Mar 27;30(5):407-415. doi: 10.1093/eurjpc/zwad007.

  PMID: 36631734 RESULT

• 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 & Control. 2023

  RESULT

• Bengtsson A, Nyman E, Gronlund C, Wester P, Naslund U, Fharm E, Norberg M. 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 Aug;39(8):1461-1471. doi: 10.1007/s10554-023-02868-0. Epub 2023 May 30.

  PMID: 37249653 RESULT

• Nordin S, Norberg M, Braf I, Johansson H, Lindahl B, Lindvall K, Nordin M, Nyman E, Vallstrom C, Wennberg P, Liv P, Naslund U. Associations between emotional support and cardiovascular risk factors and subclinical atherosclerosis in middle-age. Psychol Health. 2025 Jun;40(6):997-1011. doi: 10.1080/08870446.2023.2286296. Epub 2023 Nov 23.

  PMID: 37994844 RESULT

• Salvador D Jr, Liv P, Norberg M, Pahud de Mortanges A, Saner H, Glisic M, Nicoll R, Muka T, Nyman E, Bano A, Naslund U. Changes in fasting plasma glucose and subclinical atherosclerosis: A cohort study from VIPVIZA trial. Atherosclerosis. 2024 Jul;394:117326. doi: 10.1016/j.atherosclerosis.2023.117326. Epub 2023 Oct 17.

  PMID: 37932189 RESULT

• Sonnerstam E, Holmberg H, Carlberg B, Norberg M, Sjalander A, Glader EL. Beliefs about medicines in relation to the initiation of cardiovascular preventive medications during a 3 year follow-up period after inclusion in the VIPVIZA trial: a cohort study. BMJ Open. 2025 Dec 23;15(12):e100924. doi: 10.1136/bmjopen-2025-100924.

  PMID: 41436264 DERIVED

• Norberg M, Liv P, Naslund U, Wester P, Andersson EM, Nordin S. The Path for Men from Young Adulthood Results of Cognitive Tests to Subclinical Atherosclerosis at Age 60: The Mediating Role of Socioeconomic Status, Lifestyle and Cardiovascular Disease Risk Factors-Results from a VIPVIZA Study. Rev Cardiovasc Med. 2025 Mar 20;26(3):26312. doi: 10.31083/RCM26312. eCollection 2025 Mar.

  PMID: 40160597 DERIVED

• Soderstrom M, Gronlund C, Liv P, Nyman E, Naslund U, Wester P. Aortic arterial stiffness associates with carotid intima-media thickness and carotid plaques in younger middle-aged healthy people. Blood Press. 2024 Dec;33(1):2405161. doi: 10.1080/08037051.2024.2405161. Epub 2024 Sep 18.

  PMID: 39291635 DERIVED

• Holmberg H, Glader EL, Naslund U, Carlberg B, Sonnerstam E, Norberg M, Sjalander A. Improved adherence to statin treatment and differences in results between men and women after pictorial risk communication-a sub-study of the VIPVIZA RCT. Eur J Clin Pharmacol. 2024 Aug;80(8):1209-1218. doi: 10.1007/s00228-024-03694-6. Epub 2024 Apr 29.

  PMID: 38684558 DERIVED

• 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 Jan 24;12(1):47. doi: 10.1186/s40359-023-01467-x.

  PMID: 38268015 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr Margareta Norberg
• Organization: Umea University, Sweden

margareta.norberg@umu.se

+46907865544

Study Officials

• Patrik Wennberg, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

• Ulf Näslund, Professor,MD

  Umeå University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The cleaned structured data which is generated from the original data and does not contain personal numbers (identity data) and is stored on an encrypted E: drive on a computer that is exclusively used for VIPVIZA by the data manager. Access only by the data manager with password. The password is only known by the data manager. It is also kept in a sealed envelope in the save of the Medical Faculty. For each sub-project, data on selected variables in the structured data base is exported to a researcher by the data manager after approval from the VIPVIZA steering group. Thus, the participants' identity is masked for the outcome assessors since they have nu access neither to the original or the structured data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 8, 2013
• Study Start: April 7, 2013
• Primary Completion: November 10, 2017
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 17, 2024
• Results First Posted: May 7, 2020

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)