Wireless remote monitoring of myocardial ischemia using reconstructed 12-lead ECGs

CardioBip (CB) is a hand-held patient-activated device for recording and wireless transmission of reconstructed 12-lead ECG (12CB) based on patient specific matrices. It has 5 contact points: 3 precordial and 2 on the device top serving as limb leads when touched by index fingers. To determine whether CB could be used to monitor coronary disease (CAD) patients, we compared 12CB to simultaneous 12-lead ECGs (12L) in patients with CAD, pre-and post-exercise treadmill testing (ETT). The study goals were to assess: (1) whether 12CB can accurately reconstruct and wirelessly transmit 12-lead ECGs in CAD patients during ETT recovery; (2) whether 12CB can be used to evaluate ST segment changes in patients with exercise-induced ischemia. METHODS: 47 subjects (35 males), age 41-84, with angiography-documented CAD underwent ETT. 12L and 12CB were recorded prior to and 1, 3, and 6 min post-exercise and read in a blinded fashion by 2 expert readers. Comparisons were made with 12L treated as gold standard. RESULTS: By 12L, 24/47 patients had positive ETT (horizontal ST depression >1 mV [STD] at any of the 3 post-exercise time windows), and 23/47 were negative. By 12CB, 22/47 were positive (20 true positive [TP], 2 false positive [FP]), and 25/47 were negative (21 TN, 4 FN). Thus, 12CB was not inferior to 12L in detecting exercise-induced ischemia (p=1.0, McNemar´s test). Number of leads with STD was also compared, with CB demonstrating noninferiority (98 positive leads by 12L, 91 by CB [73 TP, 21 FP]; 748 negative leads by 12L, 755 by 12CB [737 TN, 18 FN], p=0.26). CONCLUSIONS: 12CB was non-inferior to 12L for ischemia detection and may be useful for wireless, remote detection of ischemic events in CAD patients.