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

NCT03001206 | Completed

• 1 other identifier: CL-MCG-02
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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).

ICCU patients; Stress test subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthWatch Ltd.: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 4442500, Israel

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Morris Mosseri, Prof.

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 22, 2016
• Study Start: January 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)