Clinical Application Study of Wearable Multi-channel Electrocardiogram Acquisition Equipment in the Diagnosis of Myocardial Ischemia in Patients with Suspected CHD

Launched by WEST CHINA HOSPITAL · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of wearable device that can measure heart activity to help doctors diagnose a condition called myocardial ischemia, which is a type of heart problem that can happen in patients suspected of having coronary heart disease (CHD). The trial aims to see how well this multi-channel ECG device works compared to a standard heart imaging test called SPECT-MPI. The researchers want to gather information from 107 participants who are over 18 years old and suspected of having issues with their heart. Participants will wear the device for a week and then undergo the standard heart test.

To be eligible for this study, you should be at least 18 years old and suspected of having coronary heart disease with signs of myocardial ischemia. You also need to be able to use the wearable device properly and give your informed consent to participate. However, certain health conditions, like serious heart issues or other severe illnesses, might exclude you from taking part. If you join the study, you can expect to wear the device for seven days while also providing some basic health information, and then you'll have the heart imaging test. This research is important as it could lead to better and more accessible ways to diagnose heart problems in the future.

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Eligibility criteria

• Inclusion Criteria:
• * To be eligible to participate in this study, a participant must meet all of the following criteria:
• • 1. Age \> 18 years old;
• • 2. Patients suspected of having coronary heart disease with myocardial ischemia;
• • 3. Capable of using wearable ECG monitoring devices properly;
• • 4. Informed consent obtained from the patient.
• Exclusion Criteria:
• * If a patient meets any of the following conditions, they will be excluded:
• • 1. Hemodynamic instability;
• • 2. Second to third-degree atrioventricular block, sustained ventricular tachycardia, ventricular fibrillation, severe sinus bradycardia (heart rate \< 40 beats/min).
• • 3. Known congenital heart disease, severe valvular heart disease, acute heart failure, and decompensated chronic heart failure;
• • 4. Severe comorbidities: Other diseases expected to have a life expectancy of ≤12 months; bronchial asthma or severe liver and kidney dysfunction; history of severe renal or liver function abnormalities (glomerular filtration rate \< 30 ml/(min·1.73²m²), liver failure, cirrhosis, portal hypertension, or active hepatitis), neutropenia, thrombocytopenia;
• • 5. Allergy to adenosine;
• • 6. Imaging failure, such as patient movement during the acquisition process or too rapid injection of the imaging agent.