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

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data.europa2024-06-07 更新2025-04-19 收录
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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

本项目旨在优化心血管疾病(cardiovascular diseases, CVD)的防治方法。本研究基于以下核心假说:亚临床动脉粥样硬化(subclinical atherosclerosis)的影像相关信息,能够(i)提升心血管疾病风险评估的精准性,(ii)增进对该风险的沟通与认知,从而(iii)提高受试者遵从循证药物治疗与生活方式干预的动机与依从性。本研究在西博滕干预项目(Västerbotten Intervention Program, VIP)的框架内开展,同步开展常规风险因素评估与心血管疾病防治工作。 本研究共纳入3500名心血管疾病低/中度风险的健康受试者,为其实施颈动脉超声检查,并将其随机分为两组。干预组中,受试者及其接诊医师可获取受试者自身亚临床动脉粥样硬化的彩色图像与图形信息;对照组则未被提供任何超声检查结果相关信息。研究分别于1年、3年及6.5年后开展随访,随访内容涵盖临床风险因素采样、用于生物标志物分析的血液样本采集、详尽的问卷调查与访谈。 在3年与6.5年随访节点,研究团队将重复开展颈动脉超声检查,并向所有受试者及其接诊医师告知检查结果。本数据库还包含多类登记数据:预防性药物处方记录、空气污染物暴露数据、VIP项目开展前10年与20年的健康检查数据,以及男性应征入伍相关数据。 研究将在10年后收集终点事件、心血管疾病发病与死亡的登记数据。 研究者可通过与VIPVIZA项目组内研究人员合作,获取该项目的数据门户与研究数据集。如需进一步咨询,请联系项目首席研究员(Principal Investigator, PI)乌尔夫·纳斯隆德,邮箱:ulf.naslund@umu.se

提供机构:
Umeå universitet
创建时间:
2021-11-19
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