The Application of a Portable Multichannel ECG System for the Patients Suspected to Have Possible CAD or ACS

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.

Study Overview

• Status: Recruiting
• Conditions: CAD
• Intervention / Treatment: Device: a 28-channel ECG (MECG) system

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei-Chang Huang, Master; Phone Number: 88559 02-23123456; Email: r204.cc01@gmail.com
• Study Contact Backup: Name: Wei-Tien Chang, Ph.D.; Phone Number: 65628 02-23123456; Email: wtchang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, Taiwan
    • Recruiting
    • NTUH
    • Contact: Mei-Chen Huang, master; Phone Number: 885589 02-23123456; Email: r204.cc01@gmail.com
    • Contact: Wei-Tien Chang, PhD; Phone Number: 65628 02-23123456; Email: wtchang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. >20 years
2. 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.
3. Patients visiting ER due to suspected ACS: Those who have sudden onset of chest pain or shortness of breath.

Exclusion Criteria:

1. Wound over the fore chest
2. Life-threatening malignancy in 5 years
3. Treatment with immunosuppressive agents
4. 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Self-built-in M-ECG recorders have passed the electrical.; 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.	Device: a 28-channel ECG (MECG) system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The existence of coronary stenosis on coronary angiogram	ECG QTc dispersion > 72 msec on Multichannel ECG	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localization of myocardial ischemia	Channel numbers of ECG QTc < 400 msec on Multichannel ECG	3 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Tien Chang, Ph.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: CAD，ACS，Multichannel ECG recorder
• Other Study ID Numbers: 201905108DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No