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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Device: Master Caution System

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 4442500
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: HealthWatch Ltd.
• Investigators: Principal Investigator: Morris Mosseri, Prof., Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: CL-MCG-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No