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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Master Caution System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICCU patients<br>The use of the Master Caution System (MCS) for continuous monitoring and detection of dysrhythmias and ischemic events : For patient diagnosed with acute coronary syndrome (ACS) in the intensive cardiac care unit (ICCU) before and after planed catheterization procedure. | Device: Master Caution System<br>* 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).<br>|
| Stress test subjects<br>The use of the Master Caution System (MCS) for continuous monitoring and detection of dysrhythmias and ischemic events : For patients referred to stress imaging with suspected ischemia. | Device: Master Caution System<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 |