The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events
NCT ID: NCT03001206
Last Updated: 2018-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
84 participants
OBSERVATIONAL
2017-01-31
2018-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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).
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
90 Years
ALL
No
Sponsors
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HealthWatch Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Morris Mosseri, Prof.
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir Medical Center
Kfar Saba, , Israel
Countries
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Other Identifiers
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CL-MCG-02
Identifier Type: -
Identifier Source: org_study_id
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