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

HealthWatch

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Device: Master Caution System

Study type: Observational

Funder types: Industry

Identifiers

NCT03001206

CL-MCG-02

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

84 participants in 2 patient groups

ICCU patients

Description:

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.

Treatment:

Device: Master Caution System

Stress test subjects

Description:

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.

Treatment:

Device: Master Caution System