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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03001206
Enrollment
84
Registered
2016-12-22
Start date
2017-01-31
Completion date
2018-07-31
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Brief 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.

Interventions

DEVICEMaster 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).

Sponsors

HealthWatch Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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
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

MeasureTime frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026