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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICCU patients | 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. |
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| Stress test subjects | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Master Caution System | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible subjects admitted and diagnosed as acute coronary syndrome, before or after catheterization, who need to be monitored for evaluation of treatment efficacy.
Eligible subjects referred to stress imaging test, with current or previously depicted STT changes.
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| Name | Affiliation | Role |
|---|---|---|
| Morris Mosseri, Prof. | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | 4442500 | Israel |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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