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

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

Backgroud: With the widespread application of artificial intelligence, sensor technology, and wearable technology in clinical and daily life, wearable devices have shown a promising application prospect and tremendous potential. Currently, both domestic and international clinical applications of wearable ECG devices for the diagnosis and treatment of coronary heart disease are mostly single-lead ECG wearable devices or simulated multi-lead wearable ECG monitoring devices, which are widely used in the diagnosis of arrhythmias such as atrial fibrillation. There is a lack of clinical diagnostic efficacy research on myocardial ischemia in coronary heart disease.

Aim: To investigate the diagnostic efficacy of wearable multi-channel ECG acquisition devices for myocardial ischemia in suspected CHD patients Methods：Assessing the sensitivity, specificity, and accuracy of wearable multi-channel ECG devices in diagnosing myocardial ischemia in coronary heart disease by comparing with the "gold standard" SPECT-MPI.The target recruitment is 107 suspected coronary heart disease myocardial ischemia patients.If patients do not meet the exclusion criteria, they will wear the wearable multi-channel ECG device for 7 days after enrollment, followed by a myocardial SPECT examination; there is no specific order for these examinations. After enrollment, baseline information of the patients (such as age, gender, height, weight, etc.), comorbidities (such as hypertension, diabetes, hyperlipidemia, chronic kidney disease, etc.), and auxiliary examination data (such as complete blood count, biochemistry, cardiac injury markers, BNP, echocardiography, wearable multi-channel ECG device data, SPECT-related examination data, such as ST-segment, total load score, total rest score, etc.) will be collected. The endpoint of this study is to evaluate the sensitivity, specificity, and accuracy of the wearable multi-channel ECG device in assessing myocardial ischemia in CHD.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Ischaemia; Wearable Electronic Devices; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Device: wearable multi-channel ECG acquisition devices

• Study Type: Observational
• Enrollment (Estimated): 107

Contacts and Locations

• Study Contact: Name: Zhongxiu Chen MD; Phone Number: 18030708238; Email: 619027896@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of having coronary heart disease with myocardial ischemia may exhibit symptoms such as angina, myocardial infarction, arrhythmias, heart failure, and sudden death. They may show signs of myocardial ischemia on an electrocardiogram, such as changes in the ST segment or T wave, but these changes are not specific and require further examination for confirmation.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity, and accuracy	Sensitivity, specificity, and accuracy of wearable multi-channel ECG acquisition devices in diagnosing myocardial ischemia in coronary heart disease.	After enrollment, wear the wearable multi-channel ECG device for 7 days, followed by the completion of a myocardial SPECT examination.

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: WestChinaH-CVD-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No