MediBeat - HeartBeat Observation Trial
Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
1 other identifier
interventional
94
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedStudy Start
First participant enrolled
October 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2019
CompletedResults Posted
Study results publicly available
April 1, 2020
CompletedApril 1, 2020
March 1, 2020
2 months
September 4, 2019
December 17, 2019
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
45-60 minutes
Study Arms (3)
Low Blood Pressure
OTHERLow blood pressure (systolic: 0-129, diastolic: 0-79)
Medium Blood Pressure
OTHERMedium blood pressure (systolic: 130-160, diastolic: 80-100)
High Blood Pressure
OTHERHigh blood pressure (systolic: 161 or higher, diastolic: 101 or higher)
Interventions
Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.
Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.
Eligibility Criteria
You may qualify if:
- adult over 25 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SE Healthlead
- Centre for Aging and Brain Health Innovationcollaborator
Study Sites (1)
SE Health
Markham, Ontario, L3R 6H3, Canada
Related Publications (1)
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.
PMID: 33890856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SE Research Centre
- Organization
- SE Health
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Holyoke, PhD
SE Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 9, 2019
Study Start
October 4, 2019
Primary Completion
November 22, 2019
Study Completion
December 17, 2019
Last Updated
April 1, 2020
Results First Posted
April 1, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share