The Value of Wearable Electrocardiogram in the Diagnosis of Coronary Artery Disease

Background: Patients with suspected coronary artery disease usually have symptoms such as angina, shortness of breath, and fatigue during daily life. But they may have no typical symptom when they arrived at the hospital. If routine examinations and laboratory tests such as electrocardiogram and cardiac markers cannot support the diagnosis of coronary heart disease, patients often need coronary computed tomography angiography or hospitalization for coronary angiography. This advanced diagnostic imaging has several shortcomings such as radiation exposure, long time for the appointment, certain requirements for patient's physical condition (such as exercise ability, good liver and kidney function, etc.), corresponding mental stress and economic burden to the patient. Therefore, for patients with suspected coronary artery disease but cannot be diagnosed by routine examinations, new diagnostic methods that are both safe, accurate, and economical are needed.

Aims: This project intends to assess the diagnostic value of wearable electrocardiograms for coronary artery disease. Patients will take the device home and actively record the electrocardiogram at symptoms onset. The data will be uploaded to the diagnostic center and read by professional cardiologists. The results will be compared with coronary angiography to test its diagnostic efficacy. It is hoped that the diagnosis efficiency of coronary artery disease and patients' experience can be improved.

Operating Procedures:

1. Baseline information was collected from subjects who met the inclusion criteria, including demographic information such as gender and age, chief complaints and past history, outpatient blood pressure values, 12-lead ECG results, baseline results of the wearable ECG, and hematological test results such as myocardial enzyme profile tests. The technician conducts patient education to ensure that subjects are clear about the requirements for use of the wearable ECG and how to upload it, know the process of home monitoring, and reserve contact information for both doctors and patients.
2. Participants lived a normal life at home and used the wearable ECG to collect an ECG once a day in the early morning. If symptoms related to coronary artery diseases, such as chest tightness and chest pain, occur at home, the ECG is recorded immediately using the wearable ECG, and a simple complaint of the attack is selected on the corresponding mobile app and uploaded to the cloud data center. The ECG can be collected and uploaded several times during the onset of symptoms without removing the wearable ECG, and then again after the symptoms have disappeared. If the subject's symptoms do not subside or even worsen during the period, or if the subject feels that he/she needs medical attention, he/she should go to our center or to the nearest hospital for medical treatment in a timely manner. The uploaded ECG will be interpreted by the ECG physician at the diagnostic center for abnormalities.
3. Diagnostic criteria of wearable ECG for myocardial ischemia.

① ST-segment depression of horizontal or inferior type ≥ 0.1 mV (1.0 mm), lasting ≥ 1.0 min, with an interval of ≥ 5.0 min between episodes. a significant increase/slowing of the mean heart rate during the episode compared to 10-30 min before the episode (20 beats/min increase or 10 beats/min decrease is recommended as the diagnostic reference cut point), or the concomitant presence ② ST-segment elevation showing ischemic J waves with duration ≥ 1.0 min and the interval between episodes ≥ 5.0 min. The mean heart rate during the episode is significantly increased/decreased compared with 10-30 min before the episode (an increase of 20 beats/min or a decrease of 10 beats/min is recommended as the diagnostic reference cut point) or accompanied by arrhythmias.