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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-31

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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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).

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

Intervention Type 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).

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).

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HealthWatch Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Israel

Other Identifiers

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CL-MCG-02

Identifier Type: -

Identifier Source: org_study_id

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