The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events

Acute Coronary Syndrome Clinical Trial

Official title:

The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001206
• Other study ID #: CL-MCG-02
• Status: Completed
• Start date: January 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: HealthWatch Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.

The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.

The purpose of the study is to reassess the adequate size of the Master Caution Garment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age>18 years.

• Diagnosed or have evidence of ACS, or referred for stress imaging due to suspected ischemia with STT changes.

• Needs continuous/routine ECG monitoring.

• Ability to give informed consent.

• Cooperative person

Exclusion Criteria:

• Patients with known allergy to silver.

• Patients with dermal disease or recent trauma to the chest wall.

• Pregnant or lactating woman.

• Patients with chest deformity precluding placement of the garment.

• Patients suffering from tremor.

• Patients participating in another ongoing trial.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arrhythmias, Cardiac

Intervention

Device:
• Master Caution System
The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU. The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test. The purpose of the study is to reassess the adequate size of the Master Caution Garment (MCG).

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
HealthWatch Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.		48 hours
Primary	Measuring 12 leads ECG information of patients at the stress test using Master Caution System (MCS) comparing to the standard of care stress test ECG device and Electrodes.		1-2 hours
Secondary	Master Caution System (MCS) cardiac telemetry system will measure and provide sufficient ECG information for adequate detection and interpretation of ST-T wave changes and dysrhythmic events.		during the use of the system