Contactless Radar Blood Pressure Validation
Clinical Validation of Contactless Radar Blood Pressure Device
2 other identifiers
observational
150
1 country
1
Brief Summary
The goal of this observational study is to learn how accurately blood pressure can be measured using a contactless radar device. The main questions the study aims to answer are:
- 1.how does blood pressure measured using radar compare with blood pressure using a cuff in patients with known high blood pressure?
- 2.how does blood pressure measured using radar compare with invasive blood pressure during a coronary angiogram?
- 3.can the radar blood pressure machine be used to measure blood pressuring during an MRI scan of the heart?
- 4.can the radar blood pressure machine be used to measure blood pressure during exercise?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
September 13, 2023
September 1, 2023
3 years
August 21, 2023
September 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Radar blood pressure compared with blood pressure measured by manual auscultation
To determine if the radar module can derive accurate blood pressure measurements when compared against non-invasive blood pressure measurements by manual auscultation in a group of participants with known hypertension.
3 years
Secondary Outcomes (1)
Radar blood pressure compared with blood pressure measured invasively
3 years
Other Outcomes (2)
Radar blood pressure compared with oscillometric blood pressure during a cardiac MRI scan
3 years
Radar blood pressure compared with oscillometric blood pressure during exercise
3 years
Study Arms (4)
Comparing radar and auscultatory blood pressure
25 participants will be recruited from a specialist hypertension clinic. These participants will undergo the following tests: 1. Questionnaire: The participant will be asked to complete a clinico-demographic questionnaire. This includes their demographic data and past medical history. 2. Measurement of height, weight and heart rate 3. Measurement of blood pressure using the radar device and using a cuff (called manual auscultation) 4. End of visit.
Comparing radar and invasive blood pressure
Participants will be recruited from a list of patients scheduled to attend the Royal Free Hospital catheterisation laboratory for a clinically-indicated invasive angiogram that was booked by their consultant. 50 participants aged 18 and over will be recruited. The radar blood pressure measurements taken during the angiogram will not impact on the procedure or standard clinical care which the participant will receive. The duration of the visit is determined by the duration of the coronary angiogram and that is decided by the clinical care team. Participants will have the following tests: 1. Collection of baseline data including past medical history, current medication, height, weight and baseline ECG 2. Measurement of invasive blood pressure and radar blood pressure simultaneously before the rest of the procedure 3. End of visit.
Testing if the radar device can measure blood pressure in the MRI scanner
First we will develop a radar blood pressure device that can be used in the MRI scanner. When this device has been proven to be safe, we will recruit 25 participants to have the following tests: 1. A questionnaire. The participant will be asked to complete a clinic-demographic questionnaire including their demographic data and past medical history. 2. Collection of blood test to assess kidney function. Additional blood tests will also be collected for storage and future analysis. 3. A cardiac MRI scan. Blood pressure will be measured at 5 minute intervals during the scan using an oscillometric cuff around the right upper arm. The radar device will measure blood pressure in a contactless way at the same time. 4. End of visit.
Testing if the radar device can measure blood pressure during exercise
We will recruit 50 participants the have the following tests: 1. Questionnaire: The participant will be asked to complete a clinico-demographic questionnaire. This includes their demographic data and past medical history. 2. Measurement of heart rate, breathing rate and oxygen saturations. 3. Recording a heart tracing called an ECG 4. Participants will then perform 5-10 minutes of exercise, either repeated sit-to-stand movements or using a bike ergometer. Blood pressure will be measured using a cuff and the radar device at regular intervals 5. Participants will then have a heart scan called an echocardiogram during which time the radar blood measurements will also be collected. 6. End of visit.
Interventions
The radar blood pressure device will be compared with other traditional blood pressure measurement methods.
Eligibility Criteria
Group 1: participants under the specialist hypertension clinic at the Royal Free Hospital Group 2: participants who have been selected to undergo an angiogram by a consultant cardiologist Group 3 and 4: healthy volunteers
You may qualify if:
- Group 1:
- Age \> 18 years old
- under the care of the complex hypertension clinic
- able to take auscultatory blood pressure from right arm
- Group 2:
- Age \>18
- has been selected to undergo invasive coronary angiogram by a consultant cardiologist
- Group 3:
- Age \>18
- willing to undergo a cardiac MRI scan
- Group 4:
- \- Age \> 18
You may not qualify if:
- Group 1
- anyone unable to consent
- inaudible Korotkoff K1/K5 sounds
- systolic BP difference \>12 mmHg and/or diastolic \>8 mmHg in any of the auscultatory measurements during the validation study
- contraindication to cuff-based BP measurement e.g. lymph node clearance on right side
- Group 2:
- anyone unable to consent
- anyone in whom right radial arterial access cannot be obtained (e.g. severe skin abnormality such as scleroderma)
- known arterio-venous malformation or fistulas in right arm
- any contraindication to an invasive angiogram such as severe frailty
- Group 3:
- anyone unable to consent
- anyone with a classical contraindication to an MRI study such as known metal fragments allergy to used contrast
- high degree heart block
- asthma
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCL Bloomsbury Centre for Clinical Phenotyping
London, SW13 0JD, United Kingdom
Biospecimen
25 participants will undergo radar blood pressure tests during an MRI scan of the heart. In these participants, a point of care blood test will be taken to assess kidney function using the StatSensor Xpress Creatinine monitor (Nova Biomedical, USA). Additional blood tests will also be collected for storage and future DNA and small molecule analysis. The other participants will not have biospecimens stored.
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriella Captur, PhD
University College, London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
September 13, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share