Acute Coronary SyndromeNCT03001206
The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events
An observational study of Acute Coronary Syndrome, run by HealthWatch Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Master Caution System
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Master Caution System
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Master Caution SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Master Caution System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: during the use of the system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthWatch Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Morris Mosseri, Prof., Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001206
- Sponsor's protocol ID
- CL-MCG-02
- Status last verified
- Aug 2018
- First submitted
- 7 Dec 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia
- ClinicalTrials.gov ID
- NCT03001206
- Acronym / sponsor ID
- CL-MCG-02
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- HealthWatch Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICCU patients | – | Device: Master Caution SystemThe 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. |
| Stress test subjects | – | Device: Master Caution SystemThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Master Caution SystemThe 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). | Device | ICCU patients, Stress test subjects |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morris Mosseri, Prof. principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by HealthWatch Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.