Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04787796 |
| Other study ID # |
201905108DIND |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 14, 2020 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
May 2020 |
| Source |
National Taiwan University Hospital |
| Contact |
Wei-Tien Chang, Ph.D. |
| Phone |
02-23123456 |
| Email |
wtchang[@]ntu.edu.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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).
