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NCT Number: NCT06868940

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be eligible to participate in this study, a participant must meet all of the following criteria:
  • Age > 18 years old;
  • Patients suspected of having coronary heart disease with myocardial ischemia;
  • Capable of using wearable ECG monitoring devices properly;
  • Informed consent obtained from the patient.

Exclusion criteria

  • If a patient meets any of the following conditions, they will be excluded:
  • Hemodynamic instability;
  • Second to third-degree atrioventricular block, sustained ventricular tachycardia, ventricular fibrillation, severe sinus bradycardia (heart rate < 40 beats/min).
  • Known congenital heart disease, severe valvular heart disease, acute heart failure, and decompensated chronic heart failure;
  • 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;
  • Allergy to adenosine;
  • Imaging failure, such as patient movement during the acquisition process or too rapid injection of the imaging agent.

Treatment and study plan

wearable multi-channel ECG acquisition devices

Device

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.

Primary outcomes

  1. Sensitivity, specificity, and accuracy

    Time frame: After enrollment, wear the wearable multi-channel ECG device for 7 days, followed by the completion of a myocardial SPECT examination.

    Sensitivity, specificity, and accuracy of wearable multi-channel ECG acquisition devices in diagnosing myocardial ischemia in coronary heart disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongxiu Chen MD

CONTACT

[email protected]

18030708238

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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