A prospective, randomized, controlled, multicentre trial for secondary prevention in patients with chronic coronary syndrome using a smartphone application for digital therapy: the CHANGE study protocol.

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.

A novel and simple cardiac magnetic resonance score (PE2RT) predicts outcome in takotsubo syndrome.

OBJECTIVES: To find simple imaging-based features on cardiac magnetic resonance (CMR) that are associated with major adverse cardiovascular events (MACE) in takotsubo syndrome (TTS). METHODS: Patients with TTS referred for CMR between 2007 and 2021 were retrospectively evaluated. Besides standard CMR analysis, commonly known complications of TTS based on expert knowledge were assessed and summarised via a newly developed PE2RT score (one point each for pleural effusion, pericardial effusion, right ventricular involvement, and ventricular thrombus). Clinical follow-up data was reviewed up to three years after discharge. The relationship between PE2RT features and the occurrence of MACE (cardiovascular death or new hospitalisation due to acute myocardial injury, arrhythmia, or chronic heart failure) was examined using Cox regression analysis and Kaplan-Meier estimator. RESULTS: Seventy-nine patients (mean age, 68 ± 14 years; 72 women) with TTS were included. CMR was performed in a median of 4 days (IQR, 2-6) after symptom onset. Over a median follow-up of 13.3 months (IQR, 0.4-36.0), MACE occurred in 14/79 (18%) patients: re-hospitalisation due to acute symptoms (9/79, 11%) or chronic heart failure symptoms (4/79, 5%), and cardiac death (1/79, 1%). Patients with MACE had a higher PE2RT score (median [IQR], 2 [2-3] vs 1 [0-1]; p < 0.001). PE2RT score was associated with MACE on Cox regression analysis (hazard ratio per PE2RT feature, 2.44; 95%CI: 1.62-3.68; p < 0.001). Two or more PE2RT complications were strongly associated with the occurrence of MACE (log-rank p < 0.001). CONCLUSIONS: The introduced PE2RT complication score might enable an easy-to-assess outcome evaluation of TTS patients by CMR. KEY POINTS: • Complications like pericardial effusion, pleural effusion, right ventricular involvement, and ventricular thrombus (summarised as PE2RT features) are relatively common in takotsubo syndrome. • The proposed PE2RT score (one point per complication) was associated with the occurrence of major adverse cardiac events on follow-up. • Complications easily detected by cardiac magnetic resonance imaging can help clinicians derive long-term prognostic information on patients with takotsubo syndrome.

Smartphone-guided secondary prevention for patients with coronary artery disease.

INTRODUCTION: Coronary artery disease (CAD) is the leading cause of death worldwide. Lifestyle change is a crucial part of secondary prevention. Only 30% of CAD patients follow the corresponding guideline recommendations. The widespread adoption of smartphones offers the opportunity to integrate secondary prevention into the daily routine of CAD patients. METHODS: We developed an app to integrate secondary prevention into CAD patients' everyday life (smartphone-guided secondary prevention, SGSP). The app provided a daily 15-minute program that included video-guided exercises, video sessions with background information about CAD, and a tool to record blood pressure and heart rate once a day. The SGSP app was tested with the primary outcome of 28-day adherence. The secondary outcome was a composite of (1) self-reported behavioral changes, (2) gain of knowledge about cardiovascular risk factors, and (3) an increase in quality of life. RESULTS: Of the 66 patients screened, 43 (65%) were included into the study and, of those, 17 (40%) used the app continuously for 28 days. From this group, 14 (82%) were physically more active and ten (59%) improved their dietary habits. Usage of the SGSP app was also associated with a gain of knowledge about cardiovascular risk factors (70% physical activity, 59% healthy diet). CONCLUSION: The regular use of a SGSP app appears to support lifestyle changes in patients with CAD.