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

NCT04787796 | Unknown DMC

• 1 other identifier: 201905108DIND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CAD

Keywords

CAD，ACS，Multichannel ECG recorder

Outcome Measures

Primary Outcomes (1)

• The existence of coronary stenosis on coronary angiogram

  ECG QTc dispersion \> 72 msec on Multichannel ECG

  3 days

Secondary Outcomes (1)

• Localization of myocardial ischemia

  3 days

Study Arms (1)

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.

Device: a 28-channel ECG (MECG) system

Interventions

a 28-channel ECG (MECG) system DEVICE

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 Self-built-in M-ECG recorders have passed the electrical.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Wei-Tien Chang, Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Tien Chang, Ph.D.

CONTACT

02-23123456; wtchang@ntu.edu.tw

Mei-Chang Huang, Master

CONTACT

02-23123456; r204.cc01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: March 9, 2021
• Study Start: May 14, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2025
• Last Updated: March 9, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)