VIPVIZA - Visualisering av tyst åderförkalkning för effektivare och mer jämlik prevention och minskad förtida död i hjärtkärlsjukdom ─ en randomiserad kontrollerad studie integrerad i rutinsjukvård i Västerbotten VIPVIZA VIPVIZA - VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program 2020-204-1-1 Swedish National Data Service Svensk nationell datatjänst VIPVIZA - Visualisering av tyst åderförkalkning för effektivare och mer jämlik prevention och minskad förtida död i hjärtkärlsjukdom ─ en randomiserad kontrollerad studie integrerad i rutinsjukvård i Västerbotten VIPVIZA VIPVIZA - VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program 2020-204-1-1 oai:DiVA.org:umu-206445 urn:nbn:se:umu:diva-206445 10.1093/eurjpc/zwad007 oai:DiVA.org:umu-181026 urn:nbn:se:umu:diva-181026 10.1080/02813432.2021.1882083 oai:DiVA.org:umu-206526 urn:nbn:se:umu:diva-206526 10.1016/j.bspc.2023.104886 978-91-7601-748-7 urn:nbn:se:umu:diva-139538 oai:DiVA.org:umu-204476 urn:nbn:se:umu:diva-204476 10.1007/s10554-022-02760-3 oai:DiVA.org:umu-186686 urn:nbn:se:umu:diva-186686 10.1016/j.ajpc.2021.100199 urn:nbn:se:umu:diva-78429 10.1002/jcu.22041 oai:DiVA.org:umu-191885 urn:nbn:se:umu:diva-191885 10.1016/j.jlr.2021.100144 oai:DiVA.org:umu-200460 urn:nbn:se:umu:diva-200460 10.1002/jum.16114 oai:DiVA.org:umu-186967 urn:nbn:se:umu:diva-186967 10.1016/j.pec.2021.07.045 oai:DiVA.org:umu-209575 10.1007/s10554-023-02868-0 urn:nbn:se:umu:diva-209575 oai:DiVA.org:umu-216637 10.1016/j.atherosclerosis.2023.117326 urn:nbn:se:umu:diva-216637 oai:DiVA.org:umu-218586 urn:nbn:se:umu:diva-218586 10.1016/j.socscimed.2023.116530 10.1093/ehjci/jet254 urn:nbn:se:umu:diva-91057 oai:gup.ub.gu.se/307669 10.1001/jamanetworkopen.2021.21683 urn:nbn:se:umu:diva-187088 oai:DiVA.org:umu-201549 10.1093/ehjopen/oeac003 urn:nbn:se:umu:diva-201549 10.1177/2047487319882821 urn:nbn:se:umu:diva-165791 oai:DiVA.org:umu-217344 10.1080/08870446.2023.2286296 urn:nbn:se:umu:diva-217344 oai:DiVA.org:umu-205734 urn:nbn:se:umu:diva-205734 10.1080/02813432.2023.2178850 oai:DiVA.org:umu-218585 urn:nbn:se:umu:diva-218585 10.1186/s40359-023-01467-x 10.1111/cpf.12602 urn:nbn:se:umu:diva-165443 10.1016/S0140-6736(18)32818-6 urn:nbn:se:umu:diva-154318 oai:DiVA.org:umu-150664 10.1016/j.ultrasmedbio.2018.03.013 urn:nbn:se:umu:diva-150664 oai:DiVA.org:umu-192989 urn:nbn:se:umu:diva-192989 10.1016/j.envres.2022.113061 oai:DiVA.org:umu-204766 10.1111/cpf.12811 urn:nbn:se:umu:diva-204766 Norberg, Margareta Norberg, Margareta Näslund, Ulf Näslund, Ulf Wennberg, Patrik Wennberg, Patrik Department of Public Health and Clinical Medicine, Umeå University Institutionen för Folkhälsa och klinisk medicin, Umeå Universitet 405351, 503111 405351, 503111 465621, 561591, 741711, 931135 465621, 561591, 741711, 931135 Dnr 521-2013-2708, 2016-01891, 2017-02246 Dnr 521-2013-2708, 2016-01891, 2017-02246 ALFVLL-298001, ALFVLL-643391 ALFVLL-298001, ALFVLL-643391 Dnr 20150369, 20170481) Dnr 20150369, 20170481) Swedish National Data Service Svensk nationell datatjänst Randomized Controlled Trial Randomiserad klinisk prövning [Publikationstyp] 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 Projektets syfte är att utveckla bättre metoder för prevention av hjärtkärlsjukdom. Den bygger på hypotesen att bildbaserad information om subklinisk åderförkalkning (i) ökar precisionen i bedömningen av risk för hjärtkärlsjukdom, (ii) förbättrar kommunikationen och förståelsen av risken, och som en följd (iii) ökar motivation för och följsamhet till evidensbaserad läkemedelsbehandling och levnadsvaneförändring. 3500 friska deltagare med låg/måttlig risk för hjärtkärlsjukdom har, utöver konventionell riskfaktorbedömning och prevention inom ramen för Västerbottens Hälsoundersökningar, under 2013-2016 genomgått ultraljudsundersökning av halskärlen och randomiserats till två grupper. I interventionsgruppen informerades deltagaren och hens läkare med bild och grafik i färg om individens subkliniska åderförkalkning. Till kontrollgruppen gavs ingen information om ultraljudsresultaten. Uppföljning efter 1, 3 och 6 år omfattar provtagning avseende kliniska riskfaktorer, blodprov för analys av biomarkörer, omfattande enkäter samt intervjuer. Efter 3 och 6 år upprepades ultraljudsundersökningen och samtliga deltagare och deras läkare informerades om resultatet. I databasen ingår även registerdata avseende förskrivning av läkemedel, exponeringsdata för luftföroreningar, hälsoundersökningsdata 10 och 20 år före ingång i studien, samt för männen mönstringsdata. Efter 10 år inhämtas registerdata avseende endpoints: insjuknande och död i hjärtkärlsjukdom. Åtkomst till VIPVIZAs dataportal och forskningsdata från VIPVIZA är möjlig i samarbete med forskare inom VIPVIZA-projektet. För närmare information kontakta PI Ulf Näslund ulf.naslund@umu.se 1992 1998 2000 2009 2011-01-02 2020-09-30 2012-04-11 2016-06-01 2013-04-27 2016-06-07 2013-04-29 2016-06-07 2014-05-08 2017-11-01 2014-05-08 2017-11-01 2016-01-14 2019-06-14 2016-01-16 2019-06-14 2016-09-05 2019-05-28 2016-09-05 2019-05-28 2017-01-19 2017-01-19 Sweden Sverige IndividualIndividual IndividIndivid Healthy subjects aged 40-60 years at low/moderate risk of cardiovascular disease Friska personer i åldern 40-60 år med låg/måttlig risk för hjärtkärlsjukdom Numeric 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 areteriesSubjects 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 Personer med minst en riskfaktor för hjärtkärlsjukdom påvisat vid deltagande i Västerbottens Hälsoundersökningar. Kriterier: 1) Ålder 40 år och minst en förstagradssläkting med känd hjärtkärlsjukdom före 60 års ålder 2) ÅLder 50 år och minst en av följande: Minst en förstagradssläkting med känd hjärtkärlsjukdom före 60 års ålder, bukfetma, högt blodtryck, diabetes, LDL-kolesterol minst 4.5 mmol/l , rökning. 3) Ålder 60 år. Exklusionskriterium: Förträngning mer än 50% av en halsartärPersoner med minst en riskfaktor för hjärtkärlsjukdom påvisat vid deltagande i Västerbottens Hälsoundersökningar. Kriterier: 1) Ålder 40 år och minst en förstagradssläkting med känd hjärtkärlsjukdom före 60 års ålder 2) ÅLder 50 år och minst en av följande: Minst en förstagradssläkting med känd hjärtkärlsjukdom före 60 års ålder, bukfetma, högt blodtryck, diabetes, LDL-kolesterol minst 4.5 mmol/l , rökning. 3) Ålder 60 år. Exklusionskriterium: Förträngning mer än 50% av en halsartär OtherOther ÖvrigtÖvrigt VIP historical data 20 years before baslineVIP historical data 20 years before basline VIP historiska data 20 år före baslinjenVIP historiska data 20 år före baslinjen Registry extract and/or access to biobank sampleRegistry extract and/or access to biobank sample Registerutdrag och/eller tillgång till prov i biobankRegisterutdrag och/eller tillgång till prov i biobank VIP Historical data 10 years before baselineVIP Historical data 10 years before baseline VIP historiska data 10 år före baslinjenVIP historiska data 10 år före baslinjen Registry extract and/or access to biobank sampleRegistry extract and/or access to biobank sample Registerutdrag och/eller tillgång till prov i biobankRegisterutdrag och/eller tillgång till prov i biobank The Swedish Prescribed Drug RegisterThe Swedish Prescribed Drug Register LäkemedelsregistretLäkemedelsregistret Registry extract and/or access to biobank sampleRegistry extract and/or access to biobank sample Registerutdrag och/eller tillgång till prov i biobankRegisterutdrag och/eller tillgång till prov i biobank VIP baseline (lifestyle)VIP baseline (lifestyle) VIP baslinjeVIP baslinje Registry extract and/or access to biobank sampleRegistry extract and/or access to biobank sample Registerutdrag och/eller tillgång till prov i biobankRegisterutdrag och/eller tillgång till prov i biobank Ultrasound baselineUltrasound baseline Ultraljudsundersökning baslinjenUltraljudsundersökning baslinjen Physical measurements and testsPhysical measurements and tests Fysiska mätningar och testerFysiska mätningar och tester Psychological (Problem management) , baselinePsychological (Problem management) , baseline Psykologiska faktorer (Problemhantering), baslinjenPsykologiska faktorer (Problemhantering), baslinjen Self-administered questionnaireSelf-administered questionnaire Självadministrerat frågeformulärSjälvadministrerat frågeformulär Lifestyle 1 yearLifestyle 1 year Kliniska riskfaktorer och levnadsvanor efter 1 årKliniska riskfaktorer och levnadsvanor efter 1 år Self-administered questionnaireSelf-administered questionnaire Självadministrerat frågeformulärSjälvadministrerat frågeformulär Lifestyle 1 yearLifestyle 1 year Kliniska riskfaktorer och levnadsvanor efter 1 årKliniska riskfaktorer och levnadsvanor efter 1 år Biological testsBiological tests Biologiska provtagningarBiologiska provtagningar Clinical CVD risk factors and lifestyle habits 3 yearClinical CVD risk factors and lifestyle habits 3 year Kliniska riskfaktorer och levnadsvanor efter 3 årKliniska riskfaktorer och levnadsvanor efter 3 år Self-administered questionnaireSelf-administered questionnaire Självadministrerat frågeformulärSjälvadministrerat frågeformulär Clinical CVD risk factors and lifestyle habits 3 yearClinical CVD risk factors and lifestyle habits 3 year Kliniska riskfaktorer och levnadsvanor efter 3 årKliniska riskfaktorer och levnadsvanor efter 3 år Measurements and testsMeasurements and tests Mätningar och testerMätningar och tester Ultrasound 3 yearUltrasound 3 year Utraljudsundersökning efter 3 årUtraljudsundersökning efter 3 år Physical measurements and testsPhysical measurements and tests Fysiska mätningar och testerFysiska mätningar och tester Psykologiska faktorer och reaktioner på VIPVIZA interventionen (Problemhantering), efter 3 årPsykologiska faktorer och reaktioner på VIPVIZA interventionen (Problemhantering), efter 3 år Self-administered questionnaireSelf-administered questionnaire Självadministrerat frågeformulärSjälvadministrerat frågeformulär Included study participantsIncluded study participants Inkluderade deltagareInkluderade deltagare Military service mustering registerMilitary service mustering register Värnpliktsregistret, mönstringsdataVärnpliktsregistret, mönstringsdata Registry extract and/or access to biobank sampleRegistry extract and/or access to biobank sample Registerutdrag och/eller tillgång till prov i biobankRegisterutdrag och/eller tillgång till prov i biobank Included study participantsIncluded study participants Inkluderade deltagareInkluderade deltagare Biological testsBiological tests Biologiska provtagningarBiologiska provtagningar Access to data through an external actor. Access to data is restricted. Åtkomst till data via extern aktör. Tillgång till data är begränsad. restrictedAccess Fortuin-de Smidt, M., Bergman, F., Grönlund, C., Hult, A., Norberg, M., Wennberg, M., & Wennberg, P. (2023). Early adulthood exercise capacity, but not muscle strength, associates with subclinical atherosclerosis 40 years later in Swedish men. In European Journal of Preventive Cardiology (Vol. 30, Issue 5, pp. 407–415). https://doi.org/10.1093/eurjpc/zwad007 Fortuin-de Smidt, M., Bergman, F., Grönlund, C., Hult, A., Norberg, M., Wennberg, M., & Wennberg, P. (2023). Early adulthood exercise capacity, but not muscle strength, associates with subclinical atherosclerosis 40 years later in Swedish men. In European Journal of Preventive Cardiology (Vol. 30, Issue 5, pp. 407–415). https://doi.org/10.1093/eurjpc/zwad007 urn:nbn:se:umu:diva-206445 10.1093/eurjpc/zwad007 oai:DiVA.org:umu-206445 2023 oai:DiVA.org:umu-206445 Bengtsson, A., Lindvall, K., Norberg, M., & Fhärm, E. 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