Gonzalez-Jaramillo Nathalia, Eser Prisca, Casanova Flurina, Bano Arjola, Franco Oscar H, Windecker Stephan, Räber Lorenz, Wilhelm Matthias
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Front Cardiovasc Med. 2022 Sep 30;9:976539. doi: 10.3389/fcvm.2022.976539. eCollection 2022.
Current guidelines recommend wearable activity trackers to detect insufficient physical activity (PA) and help increase PA to prevent or ameliorate cardiovascular disease. However, there is a paucity of data regarding how objectively measured PA trajectories, patterns, and sedentary time, are associated with mortality and recurrent events after percutaneous coronary intervention (PCI) in patients with established coronary artery disease (CAD). Additionally, it remains unclear if early PA and sedentary time after PCI are associated with such outcomes. Therefore, in the present study (ClinicalTrials.gov Identifier: NCT04663373), we aim to establish the associations of objectively measured PA with major adverse cardiac events and mortality at one-year follow-up.
In this single-centre observational study, patients with CAD will be prospectively recruited immediately after PCI. All the information from the clinical history, baseline characteristics, and outcomes during follow-up will be obtained from the CARDIOBASE registry. Accelerometer data will be collected for 18 days following hospital discharge and 14 days at one-year follow-up. PA trajectories will be identified by group-based trajectory modeling. Major adverse cardiac events and mortality will be prospectively monitored up to 1 year after PCI. All data will be collected using Research Electronic Data Capture.
当前指南推荐使用可穿戴活动追踪器来检测身体活动不足(PA),并帮助增加身体活动以预防或改善心血管疾病。然而,关于在已确诊冠状动脉疾病(CAD)的患者中,经客观测量的身体活动轨迹、模式和久坐时间如何与经皮冠状动脉介入治疗(PCI)后的死亡率和复发事件相关的数据却很匮乏。此外,PCI术后早期的身体活动和久坐时间是否与这些结果相关仍不清楚。因此,在本研究(ClinicalTrials.gov标识符:NCT04663373)中,我们旨在确定在一年随访期内经客观测量的身体活动与主要不良心脏事件和死亡率之间的关联。
在这项单中心观察性研究中,CAD患者将在PCI术后立即被前瞻性招募。所有临床病史、基线特征以及随访期间结局的信息将从CARDIOBASE注册库中获取。出院后18天以及一年随访期内14天将收集加速度计数据。身体活动轨迹将通过基于组的轨迹建模来识别。主要不良心脏事件和死亡率将在PCI术后前瞻性监测长达1年。所有数据将使用研究电子数据采集系统进行收集。