Low Blood PressureNCT04082819
MediBeat - HeartBeat Observation Trial
A study testing Contec CMS50EW and Sphygmomanometer in people with Low Blood Pressure and Blood Pressure, run by SE Health at 1 site in Canada.
Trial summary
The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Blood Pressure, Blood Pressure, High Blood Pressure
- What is being tested?
- Contec CMS50EW and Sphygmomanometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2019to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult over 25 years of age
Who cannot join
- those who have heart arrhythmias,
- atrial fibrillations or atrial flutters,
- an inaudible Korotkoff sound,
- wounds of the upper arms/wrists, missing fingers, and/or
- an arm circumference of more than 55 cm will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. To that end, participants were recruited from Markham, Ontario and participated in a series of alternating blood pressure measurements over a period of 45 minutes. Comparisons were made between manual measurements and device measurements to determine the quality of the device readings. Measurements were taken by trained nurses and staff were consistent across the study duration.
Read the detailed description
The gold standard instrument for blood pressure measurement is a mercury-filled sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient for client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate, reliable alternative for the traditional mercury-containing sphygmomanometer.
HeartBeat Technologies Ltd. ("Heartbeat") has developed a novel approach to measuring blood pressure after an initial blood pressure reading using the conventional measurement method, supplemented by specific characteristics of a person (age, gender, height, weight, and heart rate), has established a "baseline measurement" for the person. The "novel approach" uses a finger pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical Systems Co., Ltd., Shanghai, People's Republic of China). The finger pulse oximeter detects the changes in blood volume directly below the person's skin and indirectly measures oxygen saturation in the blood. The measurement is in the form of a photoplethysmogram (PPG) which is captured by the Contec oximeter and then, by Bluetooth technology, transmitted to a smartphone or tablet. A HeartBeat application, called MediBeat, on the smartphone or tablet then transmits the PPG to a server where a proprietary algorithm analyzes the baseline measurement for the person and the PPG to calculate the person's current blood pressure.
Heartbeat's intent is that the current blood pressure reading would then be made available to both the client and the health provider through separate web-based interfaces. Providers would be able to log onto the HeartBeat web-based application from anywhere to review and monitor the blood pressure of multiple clients, while clients can log onto the application to track their own measurements.
- Being tested
- Contec CMS50EW, Sphygmomanometer
- Medical subject headings
- Hypotension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contec CMS50EWDevice
Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.
SphygmomanometerDevice
Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.
| Study group | Role | What they receive |
|---|---|---|
| Low Blood Pressure | Other | Low blood pressure (systolic: 0-129, diastolic: 0-79) Receives: Device: Contec CMS50EW; Device: Sphygmomanometer |
| Medium Blood Pressure | Other | Medium blood pressure (systolic: 130-160, diastolic: 80-100) Receives: Device: Contec CMS50EW; Device: Sphygmomanometer |
| High Blood Pressure | Other | High blood pressure (systolic: 161 or higher, diastolic: 101 or higher) Receives: Device: Contec CMS50EW; Device: Sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings
Each device reading was compared to the manual blood pressure reading taken before (R1) and after it (R2). The degree of alignment for systolic blood pressure was calculated by taking the difference between the two scores (manual and device). The reading with the best alignment was used.
Measured: 45 - 60 minutes
Difference Between Diastolic Manual and Device Blood Pressure Readings
Each device reading was compared to the manual reading before (R1) and after (R2) it, to calculate the degree of alignment. The difference of the device and R1, and the device and R2 were taken. The smaller number was used for results reporting.
Measured: 45-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start4 Oct 2019
- Primary completion22 Nov 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- SE Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation
- Responsible party
- Sponsor
- Investigators
- Paul Holyoke, PhD, Principal investigator, SE Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082819
- Sponsor's protocol ID
- MCD307-007-1920
- Status last verified
- Mar 2020
- First submitted
- 4 Sep 2019
- Last updated
- 1 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Holyoke P, Yogaratnam K, Kalles E. Web-Based Smartphone Algorithm for Calculating Blood Pressure From Photoplethysmography Remotely in a General Adult Population: Validation Study. J Med Internet Res. 2021 Apr 23;23(4):e19187. doi: 10.2196/19187.
PubMed 33890856
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
- ClinicalTrials.gov ID
- NCT04082819
- Acronym / sponsor ID
- MCD307-007-1920
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- SE HealthUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 1 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. To that end, participants were recruited from Markham, Ontario and participated in a series of alternating blood pressure measurements over a period of 45 minutes. Comparisons were made between manual measurements and device measurements to determine the quality of the device readings. Measurements were taken by trained nurses and staff were consistent across the study duration.
Detailed description
The gold standard instrument for blood pressure measurement is a mercury-filled sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient for client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate, reliable alternative for the traditional mercury-containing sphygmomanometer.
HeartBeat Technologies Ltd. ("Heartbeat") has developed a novel approach to measuring blood pressure after an initial blood pressure reading using the conventional measurement method, supplemented by specific characteristics of a person (age, gender, height, weight, and heart rate), has established a "baseline measurement" for the person. The "novel approach" uses a finger pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical Systems Co., Ltd., Shanghai, People's Republic of China). The finger pulse oximeter detects the changes in blood volume directly below the person's skin and indirectly measures oxygen saturation in the blood. The measurement is in the form of a photoplethysmogram (PPG) which is captured by the Contec oximeter and then, by Bluetooth technology, transmitted to a smartphone or tablet. A HeartBeat application, called MediBeat, on the smartphone or tablet then transmits the PPG to a server where a proprietary algorithm analyzes the baseline measurement for the person and the PPG to calculate the person's current blood pressure.
Heartbeat's intent is that the current blood pressure reading would then be made available to both the client and the health provider through separate web-based interfaces. Providers would be able to log onto the HeartBeat web-based application from anywhere to review and monitor the blood pressure of multiple clients, while clients can log onto the application to track their own measurements.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Blood Pressure | Other | Device: Contec CMS50EW, Device: SphygmomanometerLow blood pressure (systolic: 0-129, diastolic: 0-79) |
| Medium Blood Pressure | Other | Device: Contec CMS50EW, Device: SphygmomanometerMedium blood pressure (systolic: 130-160, diastolic: 80-100) |
| High Blood Pressure | Other | Device: Contec CMS50EW, Device: SphygmomanometerHigh blood pressure (systolic: 161 or higher, diastolic: 101 or higher) |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult over 25 years of age
Key exclusion criteria (5 listed)
- those who have heart arrhythmias,
- atrial fibrillations or atrial flutters,
- an inaudible Korotkoff sound,
- wounds of the upper arms/wrists, missing fingers, and/or
- an arm circumference of more than 55 cm will be excluded
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 |
|---|---|---|
| Contec CMS50EWParticipants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit. | Device | High Blood Pressure, Low Blood Pressure, Medium Blood Pressure |
| SphygmomanometerParticipants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit. | Device | High Blood Pressure, Low Blood Pressure, Medium Blood Pressure |
Primary outcome
Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings
Time frame: 45 - 60 minutes
Each device reading was compared to the manual blood pressure reading taken before (R1) and after it (R2). The degree of alignment for systolic blood pressure was calculated by taking the difference between the two scores (manual and device). The reading with the best alignment was used.
Difference Between Diastolic Manual and Device Blood Pressure Readings
Time frame: 45-60 minutes
Each device reading was compared to the manual reading before (R1) and after (R2) it, to calculate the degree of alignment. The difference of the device and R1, and the device and R2 were taken. The smaller number was used for results reporting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33890856Holyoke P, Yogaratnam K, Kalles E. Web-Based Smartphone Algorithm for Calculating Blood Pressure From Photoplethysmography Remotely in a General Adult Population: Validation Study. J Med Internet Res. 2021 Apr 23;23(4):e19187. doi: 10.2196/19187.
- 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.
Paul Holyoke, PhD principal investigator
SE Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contec CMS50EW and Sphygmomanometer in people with Low Blood Pressure and Blood Pressure, run by SE Health at 1 site in Canada.
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 5 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 1 Apr 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings (time frame: 45 - 60 minutes). 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?
On the ClinicalTrials.gov record for NCT04082819, which also lists 1 linked publication.
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 1 Apr 2020.