Zemmrich Claudia, Bramlage Peter, Hillmeister Philipp, Sacirovic Mesud, Buschmann Ivo
Deutsche Angiologie-CRO, Berlin, Germany.
Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Vasc Health Risk Manag. 2021 May 27;17:267-272. doi: 10.2147/VHRM.S307014. eCollection 2021.
Coronary artery disease (CAD) and peripheral arterial disease (PAD) account for significant morbidity and mortality in Germany and are more prevalent in rural, non-metropolitan areas. The goal of this study is to screen patients for their current atherosclerotic status, initiate treatment according to the latest scientific findings using a standardised multimodal approach and track their atherosclerotic status over one year.
This manuscript describes the study protocol of a prospective, multicentre registry of 500 sequential patients with CAD and/or PAD in rural, non-metropolitan regions of Germany. Patients, who visit the "WalkByLab" at the Brandenburg Medical School, Brandenburg, Germany, will be assessed by using our structured, multimodal risk factor management (SMART) tool to evaluate cardiovascular morbidity data, collect information on care and deliver multimodal therapy. The study's primary objective is a cross-sectional examination of the risk profile, diagnostic and therapeutic status in this patient group. Secondary objectives include the assessment of risk factor correlations as well as changes in risk-factor profile and therapy adherence. Patients will be examined at baseline and followed up at three-monthly intervals for one year. Over this time, atherosclerotic risk factors and patient adherence to defined therapeutic strategies will be evaluated. Study completion is estimated to be December 2021. An expansion of this concept into other rural, non-metropolitan neighbouring regions is planned.
This registry was assessed and approved by the ethics committee of the Brandenburg State Medical Association, Brandenburg, Germany, and conducted in accordance with the Declaration of Helsinki. The study findings will be disseminated through usual academic channels including meeting presentations and peer-reviewed publications.
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在德国，冠状动脉疾病（CAD）和外周动脉疾病（PAD）导致了相当高的发病率和死亡率，且在农村、非大都市地区更为普遍。本研究的目的是筛查患者当前的动脉粥样硬化状况，根据最新科学发现采用标准化多模式方法启动治疗，并跟踪他们一年中的动脉粥样硬化状况。
本手稿描述了一项前瞻性、多中心登记研究的方案，该研究针对德国农村、非大都市地区连续纳入的500例CAD和/或PAD患者。在德国勃兰登堡医学院的“WalkByLab”就诊的患者，将通过使用我们的结构化多模式风险因素管理（SMART）工具进行评估，以评估心血管疾病发病数据、收集护理信息并提供多模式治疗。该研究的主要目标是对该患者群体的风险概况、诊断和治疗状况进行横断面检查。次要目标包括评估风险因素相关性以及风险因素概况和治疗依从性的变化。患者将在基线时接受检查，并在一年中每三个月随访一次。在此期间，将评估动脉粥样硬化风险因素和患者对既定治疗策略的依从性。预计研究于2021年12月完成。计划将这一概念扩展到其他农村、非大都市邻近地区。
该登记研究经德国勃兰登堡州医学协会伦理委员会评估并批准，按照《赫尔辛基宣言》进行。研究结果将通过包括会议报告和同行评审出版物在内的常规学术渠道传播。
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