Coronary Arterial Disease (CAD)NCT06868940
Clinical Application Study of Wearable Multi-channel Electrocardiogram Acquisition Equipment in the Diagnosis of Myocardial Ischemia in Patients with Suspected CHD
An observational study of Coronary Arterial Disease (CAD) and Myocardial Ischaemia, run by West China Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Myocardial Ischaemia, Wearable Electronic Devices
- What is being tested?
- wearable multi-channel ECG acquisition devices
- Type of treatment
- Medical device
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- wearable multi-channel ECG acquisition devices
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable multi-channel ECG acquisition devicesDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, and accuracy
Sensitivity, specificity, and accuracy of wearable multi-channel ECG acquisition devices in diagnosing myocardial ischemia in coronary heart disease.
Measured: After enrollment, wear the wearable multi-channel ECG device for 7 days, followed by the completion of a myocardial SPECT examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868940
- Sponsor's protocol ID
- WestChinaH-CVD-008
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Study of Wearable Multi-channel Electrocardiogram Acquisition Equipment in the Diagnosis of Myocardial Ischemia in Patients with Suspected Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT06868940
- Acronym / sponsor ID
- WestChinaH-CVD-008
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- To be eligible to participate in this study, a participant must meet all of the following criteria:
Key exclusion criteria (7 listed)
- If a patient meets any of the following conditions, they will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable multi-channel ECG acquisition devicesIf 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. | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Myocardial Ischaemia, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongxiu Chen MD (18030708238, 619027896@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.