Ulf Näslund1, Nawi Ng2, Anna Lundgren2, Eva Fhärm3, Christer Grönlund4, Helene Johansson2, Bernt Lindahl5, Bertil Lindahl6, Kristina Lindvall2, Stefan K Nilsson7, Maria Nordin8, Steven Nordin8, Emma Nyman9, Joacim Rocklöv5, Davide Vanoli9, Lars Weinehall2, Patrik Wennberg3, Per Wester10, Margareta Norberg2. 1. Heart Centre and Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden. Electronic address: ulf.naslund@umu.se. 2. Unit of Epidemiology and Global Health, Umeå University, Umeå, Sweden. 3. Unit of Family Medicine, Umeå University, Umeå, Sweden. 4. Department of Public Health and Clinical Medicine, Department of Radiation Sciences, Umeå University, Umeå, Sweden. 5. Unit of Occupational and Environmental Medicine, Umeå University, Umeå, Sweden. 6. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 7. Unit of Physiological Chemistry, Department of Medical Biosciences, Umeå University, Umeå, Sweden. 8. Department of Psychology, Umeå University, Umeå, Sweden. 9. Heart Centre and Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden. 10. Unit of Medicine, Umeå University, Umeå, Sweden.
Abstract
BACKGROUND: Primary prevention of cardiovascular disease often fails because of poor adherence among practitioners and individuals to prevention guidelines. We aimed to investigate whether ultrasound-based pictorial information about subclinical carotid atherosclerosis, targeting both primary care physicians and individuals, improves prevention. METHODS: Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial that was integrated within the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden. Individuals aged 40, 50, or 60 years with one or more conventional risk factors were eligible to participate. Participants underwent clinical examination, blood sampling, and ultrasound assessment of carotid intima media wall thickness and plaque formation. Participants were randomly assigned 1:1 with a computer-generated randomisation list to an intervention group (pictorial representation of carotid ultrasound plus a nurse phone call to confirm understanding) or a control group (not informed). The primary outcomes, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were assessed after 1 year among participants who were followed up. This study is registered with ClinicalTrials.gov, number NCT01849575. FINDINGS:3532 individuals were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group. 3175 participants completed the 1-year follow-up. At the 1-year follow-up, FRS and SCORE differed significantly between groups (FRS 1·07 [95% CI 0·11 to 2·03, p=0·0017] and SCORE 0·16 [0·02 to 0·30, p=0·0010]). FRS decreased from baseline to the 1-year follow-up in the intervention group and increased in the control group (-0·58 [95% CI -0·86 to -0·30] vs 0·35 [0·08 to 0·63]). SCORE increased in both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]). INTERPRETATION: This study provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease. It supports further development of methods to reduce the major problem of low adherence to medication and lifestyle modification. FUNDING: Västerbotten County Council, the Swedish Research Council, the Heart and Lung Foundation, the Swedish Society of Medicine, and Carl Bennet Ltd, Sweden.
RCT Entities:
BACKGROUND: Primary prevention of cardiovascular disease often fails because of poor adherence among practitioners and individuals to prevention guidelines. We aimed to investigate whether ultrasound-based pictorial information about subclinical carotid atherosclerosis, targeting both primary care physicians and individuals, improves prevention. METHODS: Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial that was integrated within the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden. Individuals aged 40, 50, or 60 years with one or more conventional risk factors were eligible to participate. Participants underwent clinical examination, blood sampling, and ultrasound assessment of carotid intima media wall thickness and plaque formation. Participants were randomly assigned 1:1 with a computer-generated randomisation list to an intervention group (pictorial representation of carotid ultrasound plus a nurse phone call to confirm understanding) or a control group (not informed). The primary outcomes, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were assessed after 1 year among participants who were followed up. This study is registered with ClinicalTrials.gov, number NCT01849575. FINDINGS: 3532 individuals were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group. 3175 participants completed the 1-year follow-up. At the 1-year follow-up, FRS and SCORE differed significantly between groups (FRS 1·07 [95% CI 0·11 to 2·03, p=0·0017] and SCORE 0·16 [0·02 to 0·30, p=0·0010]). FRS decreased from baseline to the 1-year follow-up in the intervention group and increased in the control group (-0·58 [95% CI -0·86 to -0·30] vs 0·35 [0·08 to 0·63]). SCORE increased in both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]). INTERPRETATION: This study provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease. It supports further development of methods to reduce the major problem of low adherence to medication and lifestyle modification. FUNDING: Västerbotten County Council, the Swedish Research Council, the Heart and Lung Foundation, the Swedish Society of Medicine, and Carl Bennet Ltd, Sweden.
Authors: Samuel R Montgomery; Paris D Butler; Chris J Wirtalla; Karole T Collier; Rebecca L Hoffman; Cary B Aarons; Scott M Damrauer; Rachel R Kelz Journal: Am J Surg Date: 2018-05-12 Impact factor: 2.565
Authors: Henrik Holmberg; Maria Sjölander; Eva-Lotta Glader; Ulf Näslund; Bo Carlberg; Margareta Norberg; Anders Själander Journal: Eur Heart J Open Date: 2022-02-04
Authors: Maria Rubio-Valera; Antoni Serrano-Blanco; Ignacio Aznar-Lou; Edurne Zabaleta-Del-Olmo; Marc Casajuana-Closas; Alba Sánchez-Viñas; Elizabeth Parody-Rúa; Bonaventura Bolíbar; Montserrat Iracheta-Todó; Oana Bulilete; Tomàs López-Jiménez; Haizea Pombo-Ramos; María Victoria Martín Miguel; Rosa Magallón-Botaya; Jose Ángel Maderuelo-Fernández; Emma Motrico; Juan Bellón; Ruth Martí-Lluch Journal: Int J Behav Nutr Phys Act Date: 2021-07-02 Impact factor: 6.457