High Cardiac OutputNCT02422342
Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
An observational study of High Cardiac Output and Low Cardiac Output, run by HeartBeat Technologies LTD at 1 site in Israel.
Trial summary
The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- High Cardiac Output, Low Cardiac Output
- What is being tested?
- Pulse Oximeter CMS50FW (Contec Medical)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2015to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that are referred to the Stress Echocardiography test and are not in the exclusion criteria
Who may be able to join
- Patients referred to an Stress Echocardiography test for cardiac diagnostics
- Male and Female
- Between 18 to 90 years old
Who cannot join
- Under the age of 18 or over 90 years old
- Patients in Shock
- Patients with Moderate or Severe valvular disease
- Patients with severe sepsis
- Inadequate jurisprudence patients
- Patients supported by Amines
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. The first phase of the study will be done on 10 patients undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital
Read the detailed description
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.
The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.
HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.
The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.
Trial goals
- Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
- Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
- Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index
- Conditions
- High Cardiac Output, Low Cardiac Output
- Being tested
- Pulse Oximeter CMS50FW (Contec Medical)
- Medical subject headings
- Cardiac Output, High, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Oximeter CMS50FW (Contec Medical)Device
The patients will be wearing the pulse oximeter during the test period (20-30 minutes).
The data from the oximeter will be sent by Bluetooth to the mobile application
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
Measured: Change from Baseline in Cardiac Output at 30 minutes
Secondary outcomes (2)
Blood Pressure
Measured: Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
Heart rate
Measurement of Systolic and Diastolic blood pressure at the beginning and the end of the test
Measured: Change from Baseline in heart rate at 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Cardiac OutputStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartBeat Technologies LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoram Neuman, MD, Principal investigator, Meir Health Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422342
- Sponsor's protocol ID
- HeartBeat_V2.0_SE
- Status last verified
- Feb 2019
- First submitted
- 13 Apr 2015
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
- ClinicalTrials.gov ID
- NCT02422342
- Acronym / sponsor ID
- HeartBeat_V2.0_SE
- Conditions
- High Cardiac Output, Low Cardiac Output
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HeartBeat Technologies LTDIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Apr 2015 (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 objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. The first phase of the study will be done on 10 patients undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital
Detailed description
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.
The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.
HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.
The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.
Trial goals
- Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
- Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
- Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are referred to the Stress Echocardiography test and are not in the exclusion criteria
Key inclusion criteria (3 listed)
- Patients referred to an Stress Echocardiography test for cardiac diagnostics
- Male and Female
- Between 18 to 90 years old
Key exclusion criteria (6 listed)
- Under the age of 18 or over 90 years old
- Patients in Shock
- Patients with Moderate or Severe valvular disease
- Patients with severe sepsis
- Inadequate jurisprudence patients
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 |
|---|---|---|
| Pulse Oximeter CMS50FW (Contec Medical)The patients will be wearing the pulse oximeter during the test period (20-30 minutes). The data from the oximeter will be sent by Bluetooth to the mobile application | Device | – |
Primary outcome
Cardiac Output
Time frame: Change from Baseline in Cardiac Output at 30 minutes
Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
2 secondary outcomes
Blood Pressure
Time frame: Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
Heart rate
Time frame: Change from Baseline in heart rate at 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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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.
Yoram Neuman, MD principal investigator
Meir Health Facility
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 High Cardiac Output and Low Cardiac Output, run by HeartBeat 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 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 2019. 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?
Results are not available in the source record.
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?
Cardiac Output (time frame: Change from Baseline in Cardiac Output at 30 minutes). 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 22 Feb 2019.