CADNCT04787796
The Application of a Portable Multichannel ECG System for the Patients Suspected to Have Possible CAD or ACS
A study testing a 28-channel ECG (MECG) system in people with CAD, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This clinical trial is to test if a 28-channel ECG (MECG) system would efficiently differentiate the patients suspected to have CAD or ACS with acceptable sensitivity and specificity, and optimize this portable self-built-in multichannel ECG recorder system with various algorithms. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- CAD
- What is being tested?
- a 28-channel ECG (MECG) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2020to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >20 years
- Patients admitted for cardiac catheterization examination due to clinically suspected coronary artery disease (CAD): Those who have exertional chest pain and positive ischemic change by stress test, highly suspected lesions on non-invasive images, or very typical chest pain symptoms.
- Patients visiting ER due to suspected ACS: Those who have sudden onset of chest pain or shortness of breath.
Who cannot join
- Wound over the fore chest
- Life-threatening malignancy in 5 years
- Treatment with immunosuppressive agents
- Any unfeasible condition or situation from the opinion of the primary care physicians (ex.
- critical condition needing emergency treatment or intervention, cardio pulmonary cerebral resuscitation, etc.)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei, Taiwan
Wei-Tien Chang, PhD, 02-23123456 ext. 65628, wtchang@gmail.com
Mei-Chen Huang, master, 02-23123456 ext. 885589, r204.cc01@gmail.com
About this study
Official title: The Application of a Portable Multichannel ECG System for the Patients Suspected to Have Possible Coronary Artery Disease or Acute Coronary Syndromes
This clinical trial is to test if a 28-channel ECG (MECG) system would efficiently differentiate the patients suspected to have CAD or ACS with acceptable sensitivity and specificity, and optimize this portable self-built-in multichannel ECG recorder system with various algorithms. The 28-channel ECG (MECG) system is a multi-channel real-time cardiovascular performance evaluation system. The system mainly includes: a multi-channel ECG signals measurement unit, a multi-channel ECG signals processing device, and an ECG signals reconstruction unit. The method uses a MAMA-END algorithm, to mark ECG signals to replace the original ECG signal and to extract and reconstruct a first signals having QRS wave, and a second signal having T wave; then method detects and marks the start of Q wave and the end of T wave on the first signal and the second signal. Therefore, the method is able to determine and evaluate if a patient does have cardiovascular disease, and to locate the lesion positions of a patient having cardiovascular disease.
Read the detailed description
We shall conduct this prospective clinical study to define the specific patterns of multichannel ECG change in adults with suspected CAD or ACS. For multichannel ECG (M-ECG) examination, the signal will be recorded with a Self-built-in ECG recorder. However, the examinations, diagnosis, medications, or procedures for the patients will only depend on the decision made by the primary care physicians through the traditional ways. The M-ECG results will not be used by the primary physicians for any diagnosis or decision-making of the patients. That is, the final diagnosis of CAD will be made with coronary angiography and the final diagnosis of ACS will be made with the traditional criteria (symptoms, traditional ECG changes, and cardiac enzyme changes).
Multichannel ECG Study The Self-built-in M-ECG recorders have passed the electrical security test. Multichannel ECG study will be performed under the approval of the Institutional Review Board. Before ECG examination, subjects will receive adequate orientation of the examination procedures and will complete inform consent.
During the ECG recording ,the patent will lie down flat on the bed, and 4 ECG leads with commercially available pads (Covidien Kendall ECG electrodes Medi-trace 200) will be applied on the 4 extremities, respectively. Using xyphoid process as a right lower reference point, a 18cm x 18cm patch integrated with 24 evenly distributed electrode pads (Covidien Kendall ECG electrodes Medi-trace Mini 100) will be applied on the left chest wall . Then, the ECG signals will be recorded through the self-built-in ECG recorders. The overall period for recording will be around 10 minutes.
The postprocessing and analysis of the ECG data will be performed with a PC computer by an analyzer without prior knowledge of the patient's clinical information. After ECG data is acquired, the analytic software will provide an electrical mapping of QTc dispersion (SIQTC).
- Conditions
- CAD
- Being tested
- a 28-channel ECG (MECG) system
- Keywords
- CAD，ACS，Multichannel ECG recorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a 28-channel ECG (MECG) systemDevice
To test if a 28-channel ECG (MECG) system would efficiently differentiate the patients suspected to have CAD or ACS with acceptable sensitivity and specificity, and optimize this portable self-built-in multichannel ECG recorder system with various algorithms.
| Study group | Role | What they receive |
|---|---|---|
| The Self-built-in M-ECG recorders have passed the electrical. | Experimental | We shall conduct this prospective clinical study to define the specific patterns of multichannel ECG change in adults with suspected CAD or ACS. For multichannel ECG (M-ECG) examination, the signal will be recorded with a Self-built-in ECG recorder. Receives: Device: a 28-channel ECG (MECG) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The existence of coronary stenosis on coronary angiogram
ECG QTc dispersion > 72 msec on Multichannel ECG
Measured: 3 days
Secondary outcomes (1)
Localization of myocardial ischemia
Channel numbers of ECG QTc < 400 msec on Multichannel ECG
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start14 May 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Tien Chang, Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787796
- Sponsor's protocol ID
- 201905108DIND
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of a Portable Multichannel ECG System for the Patients Suspected to Have Possible Coronary Artery Disease or Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT04787796
- Acronym / sponsor ID
- 201905108DIND
- Conditions
- CAD
- Keywords
- CAD，ACS，Multichannel ECG recorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 9 Mar 2021 (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.
This clinical trial is to test if a 28-channel ECG (MECG) system would efficiently differentiate the patients suspected to have CAD or ACS with acceptable sensitivity and specificity, and optimize this portable self-built-in multichannel ECG recorder system with various algorithms. The 28-channel ECG (MECG) system is a multi-channel real-time cardiovascular performance evaluation system. The system mainly includes: a multi-channel ECG signals measurement unit, a multi-channel ECG signals processing device, and an ECG signals reconstruction unit. The method uses a MAMA-END algorithm, to mark ECG signals to replace the original ECG signal and to extract and reconstruct a first signals having QRS wave, and a second signal having T wave; then method detects and marks the start of Q wave and the end of T wave on the first signal and the second signal. Therefore, the method is able to determine and evaluate if a patient does have cardiovascular disease, and to locate the lesion positions of a patient having cardiovascular disease.
Detailed description
We shall conduct this prospective clinical study to define the specific patterns of multichannel ECG change in adults with suspected CAD or ACS. For multichannel ECG (M-ECG) examination, the signal will be recorded with a Self-built-in ECG recorder. However, the examinations, diagnosis, medications, or procedures for the patients will only depend on the decision made by the primary care physicians through the traditional ways. The M-ECG results will not be used by the primary physicians for any diagnosis or decision-making of the patients. That is, the final diagnosis of CAD will be made with coronary angiography and the final diagnosis of ACS will be made with the traditional criteria (symptoms, traditional ECG changes, and cardiac enzyme changes).
Multichannel ECG Study The Self-built-in M-ECG recorders have passed the electrical security test. Multichannel ECG study will be performed under the approval of the Institutional Review Board. Before ECG examination, subjects will receive adequate orientation of the examination procedures and will complete inform consent.
During the ECG recording ,the patent will lie down flat on the bed, and 4 ECG leads with commercially available pads (Covidien Kendall ECG electrodes Medi-trace 200) will be applied on the 4 extremities, respectively. Using xyphoid process as a right lower reference point, a 18cm x 18cm patch integrated with 24 evenly distributed electrode pads (Covidien Kendall ECG electrodes Medi-trace Mini 100) will be applied on the left chest wall . Then, the ECG signals will be recorded through the self-built-in ECG recorders. The overall period for recording will be around 10 minutes.
The postprocessing and analysis of the ECG data will be performed with a PC computer by an analyzer without prior knowledge of the patient's clinical information. After ECG data is acquired, the analytic software will provide an electrical mapping of QTc dispersion (SIQTC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Self-built-in M-ECG recorders have passed the electrical. | Experimental | Device: a 28-channel ECG (MECG) systemWe shall conduct this prospective clinical study to define the specific patterns of multichannel ECG change in adults with suspected CAD or ACS. For multichannel ECG (M-ECG) examination, the signal will be recorded with a Self-built-in ECG recorder. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >20 years
- Patients admitted for cardiac catheterization examination due to clinically suspected coronary artery disease (CAD): Those who have exertional chest pain and positive ischemic change by stress test, highly suspected lesions on non-invasive images, or very typical chest pain symptoms.
- Patients visiting ER due to suspected ACS: Those who have sudden onset of chest pain or shortness of breath.
Key exclusion criteria (5 listed)
- Wound over the fore chest
- Life-threatening malignancy in 5 years
- Treatment with immunosuppressive agents
- Any unfeasible condition or situation from the opinion of the primary care physicians (ex.
- critical condition needing emergency treatment or intervention, cardio pulmonary cerebral resuscitation, etc.)
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 |
|---|---|---|
| a 28-channel ECG (MECG) systemTo test if a 28-channel ECG (MECG) system would efficiently differentiate the patients suspected to have CAD or ACS with acceptable sensitivity and specificity, and optimize this portable self-built-in multichannel ECG recorder system with various algorithms. | Device | The Self-built-in M-ECG recorders have passed the electrical. |
Primary outcome
The existence of coronary stenosis on coronary angiogram
Time frame: 3 days
ECG QTc dispersion > 72 msec on Multichannel ECG
1 secondary outcome
Localization of myocardial ischemia
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wei-Tien Chang, Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a 28-channel ECG (MECG) system in people with CAD, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Tien Chang, Ph.D. (02-23123456 ext. 65628, wtchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The existence of coronary stenosis on coronary angiogram (time frame: 3 days). 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 9 Mar 2021.