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Aims Coronary artery disease (CAD) remains the leading cause of death worldwide. ‘Stable’ CAD is a chronic progressive condition, which recent European guidelines recommend referring to as ‘chronic coronary syndrome’ (CCS). Despite therapeutic advances, morbidity and mortality among patients with CCS remain high. Optimal secondary prevention in patients with CCS includes optimization of modifiable risk factors with behavioural changes and pharmacological therapy. The CHANGE study aims to provide evidence for optimization of secondary prevention in CCS patients by using a smartphone application (app). Methods and results The CHANGE study is designed as a prospective, randomized, controlled trial with a 1:1 allocation ratio, which is currently performed in nine centres in Germany in a parallel group design. 210 patients with CCS will be randomly allocated either to the control group (standard-of-care) or to the intervention group, who will be provided the VantisTherapy* app in addition to standard-of-care to incorporate secondary prevention into their daily life. The study will be performed in an open design. Outcomes will be assessed using objective data from three in-person visits (0, 12, and 24 weeks). Primary outcomes will involve adherence to secondary prevention recommendations and quality of life (QoL). The recruitment process started in July 2022. Conclusion The CHANGE study will investigate whether a smartphone-guided secondary prevention app, combined with a monitor function compared with standard-of-care, has beneficial effects on overall adherence to secondary prevention guidelines and QoL in patients with CCS. Trial registration The study is listed at the German study registry (DRKS) under the registered number DRKS00028081.

Aims Intracranial haemorrhage (ICH) is one of the most serious complications of adult patients treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO) and is associated with increased morbidity and mortality. However, the prevalence and risk factors of ICH in this cohort are still insufficiently understood. We hypothesized that a considerable proportion of patients undergoing VA-ECMO support suffer from ICH and that specific risk factors are associated with the occurrence of ICH. Therefore, the purpose of this study was to further investigate the prevalence and associated mortality as well as to identify risk factors for ICH in VA-ECMO patients. Methods and results We conducted a retrospective multicentre study including adult patients (≥18 years) treated with VA-ECMO in cardiac intensive care units (ICUs) at five German clinical sites between January 2016 and March 2020, excluding patients with ICH upon admission. Differences in baseline characteristics and clinical outcome between VA-ECMO patients with and without ICH were analysed and risk factors for ICH were identified. Among the 598 patients included, 70/598 (12%) developed ICH during VA-ECMO treatment. In-hospital mortality in patients with ICH was 57/70 (81%) and 1-month mortality 60/70 (86%), compared to 332/528 (63%) (P = 0.002) and 340/528 (64%) (P < 0.001), respectively, in patients without ICH. Intracranial haemorrhage was positively associated with diabetes mellitus [odds ratio (OR) 2, 95% confidence interval (CI) 1.11–3.56; P = 0.020] and lactate (per mmol/L) (OR 1.06, 95% CI 1.01–1.11; P = 0.020), and negatively associated with platelet count (per 100 G/L) (OR 0.32, 95% CI 0.15–0.59; P = 0.001) and fibrinogen (per 100 mg/dL) (OR 0.64, 95% CI 0.49–0.83; P < 0.001). Conclusion Intracranial haemorrhage was associated with a significantly higher mortality rate. Diabetes mellitus and lactate were positively, platelet count, and fibrinogen level negatively associated with the occurrence of ICH. Thus, platelet count and fibrinogen level were revealed as potentially modifiable, independent risk factors for ICH. The findings address an area with limited data, provide information about risk factors and the epidemiology of ICH, and may be a starting point for further investigations to develop effective strategies to prevent and treat ICH.