Acute Cardiac EventNCT04635371
Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor
An observational study of Acute Cardiac Event and Acute Cardiac Failure, run by Biobeat Technologies Ltd. at 1 site in Israel.
Trial summary
A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Acute Cardiac Event, Acute Cardiac Failure, Acute Cardiac Pulmonary Edema
- What is being tested?
- Non-invasive Monitoring
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2020to 30 Jun 2021
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 men and women admitted to the cardiac ICU with acute caridac event.
Who may be able to join
- Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event.
Who cannot join
- Pregnant women, subjects under the age of 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive PPG-based Monitor in the Cardiac ICU
A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.
- Being tested
- Non-invasive Monitoring
- Keywords
- Acute Catdiac Events; Remote Patient Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive MonitoringDevice
Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cardio-respiratory changes
Detection of acute cardio-respiratory/hemodynamic changes during hospitalization and during interventional procedures conducted in the cardiac ICU.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Workflow assessment.
Nursing staff will be asked - using questionnaires - to assess whether the use of these devices helps in reducing burden of work and increase other interactions with the patients.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start20 Nov 2020
- Primary completion15 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cardiac EventStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biobeat Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronen Rubinshtein, MD, Principal investigator, The Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635371
- Sponsor's protocol ID
- PPGCICUWOMC
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive PPG-based Monitor in the Cardiac ICU
- ClinicalTrials.gov ID
- NCT04635371
- Acronym / sponsor ID
- PPGCICUWOMC
- Keywords
- Acute Catdiac Events; Remote Patient Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Biobeat Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- 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.
A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 men and women admitted to the cardiac ICU with acute caridac event.
Key inclusion criteria (1 listed)
- Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event.
Key exclusion criteria (1 listed)
- Pregnant women, subjects under the age of 18 years.
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 |
|---|---|---|
| Non-invasive MonitoringWearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively. | Device | – |
Primary outcome
Detection of cardio-respiratory changes
Time frame: Through study completion, an average of 1 year.
Detection of acute cardio-respiratory/hemodynamic changes during hospitalization and during interventional procedures conducted in the cardiac ICU.
1 secondary outcome
Workflow assessment.
Time frame: Through study completion, an average of 1 year.
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 7 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ronen Rubinshtein, MD principal investigator
The Edith Wolfson 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 Cardiac Event and Acute Cardiac Failure, run by Biobeat Technologies 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 1 inclusion and 1 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 7 Jul 2021. 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?
Detection of cardio-respiratory changes (time frame: Through study completion, an average of 1 year.). 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 7 Jul 2021.