Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention
NCT ID: NCT01849575
Last Updated: 2024-01-17
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
3532 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-04-07
Study Completion Date
2027-12-31
Brief Summary
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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.
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Detailed Description
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Project description
The main objective of this project is to contribute to improved primary prevention of cardiovascular disease through the provision of a visual image and pictorial report of atherosclerosis while still asymptomatic. The image and report are seen and discussed by both physician and patient in order to improve guideline adherence and patient perception and understanding of the CVD risk and consequent motivation for prevention. The specific objectives include: 1. To assess the prevalence of asymptomatic atherosclerotic disease in men and women through identification of carotid plaques and measurement of carotid intima-media thickness (CIMT), and to relate plaques and CIMT to clinically estimated CVD risk factors and risk scores; 2. To explore the impact of pictorial representations of atherosclerosis on physicians´ adherence to prevention guidelines, and on individuals' quality of life, preventive measures, risk factor control and progress of atherosclerotic disease over the course of three and six years, as well as on premature CVD morbidity and mortality over the course of 5 and 10 years; 3. To evaluate how individuals' social, psychological, and cognitive characteristics relate to health behaviours, atherosclerosis and CVD risk at baseline and progression of any atherosclerosis; 4. To investigate biomarkers in relation to CIMT and plaques at baseline, changes in conventional CVD risk markers and lifestyle, and progression of atherosclerosis.
Survey of the field Primary prevention of CVD often fails due to poor adherence among practitioners and patients to evidence-based prevention guidelines on effective modification of risk factors by lifestyle change and pharmacological treatment. Contributory factors include poor communication about the CVD risk by the physician and inaccurate risk perception among patients. The risk message is usually communicated verbally or numerically, while potentially more effective visual tools are seldom used. For the clinical assessment of CVD risk the FRS and the European SCORE are most widely used. However, evidence that their use translates into reduced CVD morbidity and mortality is scarce. These risk scores focus on high-risk individuals, despite 60-70% of all CVD events occurring among individuals at low or intermediate risk for CVD. They might also be too abstract to lead to accurate risk perception and to motivate individuals to take preventive actions; information alone seldom results in rational behavior modification. VIPVIZA takes a different approach from current practice for the prevention of CVD. Instead of being based solely on indirect risk factors, this project evaluates the atherosclerotic disease itself while it still is subclinical, providing improved assessment, communication and perception of the CVD risk and hence greater motivation for prevention. This is achieved with ultrasonography of medium sized arteries with assessment of CIMT and existing atherosclerotic plaques.
Design, setting and study population:
The study is a pragmatic randomised open-label controlled trial with blinded evaluators (PROBE). VIPVIZA is integrated in and added to the ordinary Västerbotten Intervention Programme (VIP). Individuals with at least one clinical CVD risk factor were invited to the VIPVIZA trial when they participated in VIP (n=4177), resulting in inclusion of 3532 participants. Baseline visits with ultrasound examinations were carried out from April 29 2013 to June 7 2016. Participants were consecutively and randomly allocated to two groups (intervention and control group) using a computer-generated randomization list. The ultrasound examinations in VIPVIZA at baseline as well as after three and six years are performed at the hospitals in the three cities/towns (Umeå, Skellefteå, Lycksele), and in remote rural areas at primary health care centres. Risk factor measurements and questionnaires at follow-up after one, three and six years are carried out for participants living in Umeå at the Clinical Research Centre at Umeå University Hospital, and for participants in the rest of the county at their local primary health care center. Both groups are managed according to clinical guidelines for CVD prevention within primary care (not by the study team).
Intervention At baseline, pictorial representation of the carotid ultrasound results was given to each participant in the intervention group and their primary care physician. Atherosclerosis was presented as vascular age, with a gauge ranging from green through yellow, orange and red to illustrate the individual's biological age compared to chronological,age. A red or a green circle, like a traffic light, illustrated detected or no detected plaque, respectively. Brief written information about atherosclerosis as a dynamic process that is modifiable by a healthy lifestyle and pharmacological treatment, an interpretation of the result and general advice on CVD prevention were included. After 2-4 weeks, participants received a follow-up phone call by a research nurse in order to reassure and give additional information as needed. The same pictorial information was repeated to participants after 6 months. No information about the ultrasound result was given to the control group and their physicians.
At three- and six-year follow-up both the intervention and the control group participants and their respective primary care physician receive information about ultrasound results with the same format as was given to the intervention group at baseline. Thus, the intervention is completed at the time-point for three-year follow-up. After that the two groups are continuously followed through registries and compared with respect to atherosclerosis development and hard outcomes.
Data collection:
Clinical risk factors for cardiovascular disease: Measured at the baseline VIP health survey, at 1-, 3- and 6-year follow-up (blood pressure, lipids, and glucose, BMI and waist circumference).
Questionnaires: The VIP questionnaire covers health, socioeconomic situation, quality of life (RAND 36), lifestyle (physical activity, tobacco and alcohol consumption, diet), working conditions, social network. Validated psychometric instruments at baseline and 3-year follow-up included health literacy, coping strategies, an optimism-pessimism scale, self-efficacy, HADS and self-rated risk of CVD. Perceptions about preventive medication and a stress questionnaire at the 3-year follow-up. At 3-year follow-up questions on health literacy, coping strategies and optimism/pessimism are replaced by questionnaires on personality and dental care.
Carotid ultrasound examinations are performed at baseline, after 3 and6 years according to a standardized protocol.
Interviews: With subsamples of participants after the first, second and third ultrasound examination, and with primary care physicians after the first ultrasound examination.
Stored samples of blood to the Medical Biobank: This is done at the baseline VIP visit and at 3- and 6-year follow-up among participants, to be used for analyses of novel biomarkers Register data: Prescriptions, visits and risk factor measurements from the medical records system in Västerbotten County. Dental health and dental radiological examinations from Dental care. The Prescriptions register, Hospitalizations register and Causes of deaths register at the National Board of Health and Welfare. In addition, physical and psychological functioning and blood-group at military patterning at age around 18 from the Conscripts registry (for male participants only), educational level and income from Statistics Sweden and air pollutants by geographical region in the County of Västerbotten.
Time plan The study progress is largely according to the plan. Baseline examinations were conducted April 2013-June 2016, the 1-year follow-up examinations June 2014-August 2017, and the 3-year examinations September 2016 - June 2019. The six-year follow-up examinations started December 2019 which is a delay of 6 months due to administrative reasons. Register data from medical records, Statistics Sweden, the Conscripts register, Air-borne pollutants are underway April 2020. Data on morbidity and mortality will be retrieved in 2027, i.e. one year later than 10 years after trial start due to delay until data on events has been entered into the registries.
Ethical approval:
Study protocol version 4.0:
The VIPIVZA trial: Dnr 2011-445-32M date Feb 7 2012. Amendment 1: Dnr 2012-463-32M date December 19 2012. Amendment 2: Dnr 2013 373-32M date October 15 1013. Amendment 3: Dnr 2016-245-32M date May 31 2016. Amendment 4: Dnr 2017-95-32M date February 27 2017. Amendment 5: Dnr 2018-182-32 date May 28 2018.
Study protocol version 5.0:
Amendment 6: Dnr 2018-482-32M Date December 27 2018. Amendment 7: Dnr 2019-04619 Date September 24 2019.
The main objective of this project is to contribute to improved primary prevention of cardiovascular disease through the provision of a visual image and pictorial report of atherosclerosis while still asymptomatic. The image and report are seen and discussed by both physician and patient in order to improve guideline adherence and patient perception and understanding of the CVD risk and consequent motivation for prevention. The specific objectives include: 1. To assess the prevalence of asymptomatic atherosclerotic disease in men and women through identification of carotid plaques and measurement of carotid intima-media thickness (CIMT), and to relate plaques and CIMT to clinically estimated CVD risk factors and risk scores; 2. To explore the impact of pictorial representations of atherosclerosis on physicians´ adherence to prevention guidelines, and on individuals' quality of life, preventive measures, risk factor control and progress of atherosclerotic disease over the course of three and six years, as well as on premature CVD morbidity and mortality over the course of 5 and 10 years; 3. To evaluate how individuals' social, psychological, and cognitive characteristics relate to health behaviours, atherosclerosis and CVD risk at baseline and progression of any atherosclerosis; 4. To investigate biomarkers in relation to CIMT and plaques at baseline, changes in conventional CVD risk markers and lifestyle, and progression of atherosclerosis.
Survey of the field Primary prevention of CVD often fails due to poor adherence among practitioners and patients to evidence-based prevention guidelines on effective modification of risk factors by lifestyle change and pharmacological treatment. Contributory factors include poor communication about the CVD risk by the physician and inaccurate risk perception among patients. The risk message is usually communicated verbally or numerically, while potentially more effective visual tools are seldom used. For the clinical assessment of CVD risk the FRS and the European SCORE are most widely used. However, evidence that their use translates into reduced CVD morbidity and mortality is scarce. These risk scores focus on high-risk individuals, despite 60-70% of all CVD events occurring among individuals at low or intermediate risk for CVD. They might also be too abstract to lead to accurate risk perception and to motivate individuals to take preventive actions; information alone seldom results in rational behavior modification. VIPVIZA takes a different approach from current practice for the prevention of CVD. Instead of being based solely on indirect risk factors, this project evaluates the atherosclerotic disease itself while it still is subclinical, providing improved assessment, communication and perception of the CVD risk and hence greater motivation for prevention. This is achieved with ultrasonography of medium sized arteries with assessment of CIMT and existing atherosclerotic plaques.
Design, setting and study population:
The study is a pragmatic randomised open-label controlled trial with blinded evaluators (PROBE). VIPVIZA is integrated in and added to the ordinary Västerbotten Intervention Programme (VIP). Individuals with at least one clinical CVD risk factor were invited to the VIPVIZA trial when they participated in VIP (n=4177), resulting in inclusion of 3532 participants. Baseline visits with ultrasound examinations were carried out from April 29 2013 to June 7 2016. Participants were consecutively and randomly allocated to two groups (intervention and control group) using a computer-generated randomization list. The ultrasound examinations in VIPVIZA at baseline as well as after three and six years are performed at the hospitals in the three cities/towns (Umeå, Skellefteå, Lycksele), and in remote rural areas at primary health care centres. Risk factor measurements and questionnaires at follow-up after one, three and six years are carried out for participants living in Umeå at the Clinical Research Centre at Umeå University Hospital, and for participants in the rest of the county at their local primary health care center. Both groups are managed according to clinical guidelines for CVD prevention within primary care (not by the study team).
Intervention At baseline, pictorial representation of the carotid ultrasound results was given to each participant in the intervention group and their primary care physician. Atherosclerosis was presented as vascular age, with a gauge ranging from green through yellow, orange and red to illustrate the individual's biological age compared to chronological,age. A red or a green circle, like a traffic light, illustrated detected or no detected plaque, respectively. Brief written information about atherosclerosis as a dynamic process that is modifiable by a healthy lifestyle and pharmacological treatment, an interpretation of the result and general advice on CVD prevention were included. After 2-4 weeks, participants received a follow-up phone call by a research nurse in order to reassure and give additional information as needed. The same pictorial information was repeated to participants after 6 months. No information about the ultrasound result was given to the control group and their physicians.
At three- and six-year follow-up both the intervention and the control group participants and their respective primary care physician receive information about ultrasound results with the same format as was given to the intervention group at baseline. Thus, the intervention is completed at the time-point for three-year follow-up. After that the two groups are continuously followed through registries and compared with respect to atherosclerosis development and hard outcomes.
Data collection:
Clinical risk factors for cardiovascular disease: Measured at the baseline VIP health survey, at 1-, 3- and 6-year follow-up (blood pressure, lipids, and glucose, BMI and waist circumference).
Questionnaires: The VIP questionnaire covers health, socioeconomic situation, quality of life (RAND 36), lifestyle (physical activity, tobacco and alcohol consumption, diet), working conditions, social network. Validated psychometric instruments at baseline and 3-year follow-up included health literacy, coping strategies, an optimism-pessimism scale, self-efficacy, HADS and self-rated risk of CVD. Perceptions about preventive medication and a stress questionnaire at the 3-year follow-up. At 3-year follow-up questions on health literacy, coping strategies and optimism/pessimism are replaced by questionnaires on personality and dental care.
Carotid ultrasound examinations are performed at baseline, after 3 and6 years according to a standardized protocol.
Interviews: With subsamples of participants after the first, second and third ultrasound examination, and with primary care physicians after the first ultrasound examination.
Stored samples of blood to the Medical Biobank: This is done at the baseline VIP visit and at 3- and 6-year follow-up among participants, to be used for analyses of novel biomarkers Register data: Prescriptions, visits and risk factor measurements from the medical records system in Västerbotten County. Dental health and dental radiological examinations from Dental care. The Prescriptions register, Hospitalizations register and Causes of deaths register at the National Board of Health and Welfare. In addition, physical and psychological functioning and blood-group at military patterning at age around 18 from the Conscripts registry (for male participants only), educational level and income from Statistics Sweden and air pollutants by geographical region in the County of Västerbotten.
Time plan The study progress is largely according to the plan. Baseline examinations were conducted April 2013-June 2016, the 1-year follow-up examinations June 2014-August 2017, and the 3-year examinations September 2016 - June 2019. The six-year follow-up examinations started December 2019 which is a delay of 6 months due to administrative reasons. Register data from medical records, Statistics Sweden, the Conscripts register, Air-borne pollutants are underway April 2020. Data on morbidity and mortality will be retrieved in 2027, i.e. one year later than 10 years after trial start due to delay until data on events has been entered into the registries.
Ethical approval:
Study protocol version 4.0:
The VIPIVZA trial: Dnr 2011-445-32M date Feb 7 2012. Amendment 1: Dnr 2012-463-32M date December 19 2012. Amendment 2: Dnr 2013 373-32M date October 15 1013. Amendment 3: Dnr 2016-245-32M date May 31 2016. Amendment 4: Dnr 2017-95-32M date February 27 2017. Amendment 5: Dnr 2018-182-32 date May 28 2018.
Study protocol version 5.0:
Amendment 6: Dnr 2018-482-32M Date December 27 2018. Amendment 7: Dnr 2019-04619 Date September 24 2019.
Conditions
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Cardiovascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
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.
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.
Study Groups
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Intervention
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
Group Type
ACTIVE_COMPARATOR
Intervention
Intervention Type
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.
Control
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
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Intervention
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.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Information about ultrasound results
Eligibility Criteria
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Inclusion Criteria
\- Participant in the Västerbotten Intervention Programme
and
* 40 years old and a history of CVD at age \< 60 years among first-degree relative
or
* 50 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
or
* 60 years old
and
* 40 years old and a history of CVD at age \< 60 years among first-degree relative
or
* 50 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
or
* 60 years old
Exclusion Criteria
* Stenosis ≥50% of the carotid lumen
Minimum Eligible Age
40 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Västerbotten County Council, Sweden
OTHER_GOV
Sponsor Role
collaborator
Umeå University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Patrik Wennberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Ulf Näslund, Professor,MD
Role: PRINCIPAL_INVESTIGATOR
Umeå University Hospital
Locations
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Clinical Reseach Center Umeå University Hospital
Umeå, , Sweden
Site Status
Countries
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Sweden
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Primary outcome from base line up to one year of follow up
Document Type: Statistical Analysis Plan: Secondary outcomes up to 10 years of follow-up
Document Type: Statistical Analysis Plan: Evaluation after 6 years
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VIPVIZA version 20121204
Identifier Type: -
Identifier Source: org_study_id
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