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Completed

NCT Number: NCT03001206

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

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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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, 4442500, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

    Time frame: 48 hours

  2. 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.

    Time frame: 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.

    Time frame: during the use of the system

Sponsors and collaborators

Lead sponsor

HealthWatch Ltd.

Industry

Registry information

Official study title

The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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