Clinical trial NCT06035107: Contactless Radar Blood Pressure Validation
Official title: Clinical Validation of Contactless Radar Blood Pressure Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Pressure
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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?

Participants in this study will have the following tests:

Group 1: blood pressure measured with the radar device and a cuff when resting Group 2: blood pressure measured with the radar device and by placing a small tube inside the arteries of the wrist (during a clinical procedure) Group 3: blood pressure measured with the radar device and a cuff during a cardiac MRI scan Group 4: blood pressure measured with the radar device and a cuff during exercise

Detailed description: High blood pressure is the biggest risk factor for heart attacks and strokes. There are several machines available for measuring blood pressure, but most of them need to contact the skin causing discomfort from the inflatable cuff or risking the transmission of infections from reusing cuffs. There are also situations where the cuff machines are inaccurate, such as in older people or during exercise. Therefore, the investigators are trying to develop an accurate contactless system for measuring blood pressure.

The investigators have used advanced but safe radar to create a small machine with a camera that can measure blood pressure from a distance without the need to contact the participant's skin anywhere. It works by detecting tiny movements and changes on the skin produced from the heartbeat and pulse that cannot be seen with the human eye. The investigators want to study how accurate our radar blood pressure machine is by comparing it to other traditional methods of measuring blood pressure.

Firstly, radar blood pressure will be compared to auscultatory blood pressure (a blood pressure system using a cuff) in a group of 25 participants at rest attending a specialist blood pressure clinic. This is currently the internationally recommended method for validating new blood pressure devices.

Then radar blood pressure will be compared with invasive blood pressure (measured inside the arteries by a small tube) in 50 participants undergoing clinically-indicated cardiac catheterisation at the Royal Free Hospital.

Next a radar device capable of measuring blood pressure in participants lying inside the cardiovascular magnetic resonance (CMR) scanner will be developed. The radar blood pressure derived in the CMR scanner will be compared to oscillometric blood pressure in 25 participants (a cuff-based BP system that is currently used in patients being scanned). Finally, radar-BP will be compared with oscillometric BP in 50 participants during exercise including sit-to-stand movements and using a bike ergometer.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Group 4:

* anyone unable to consent
* anyone with exertional chest pain or known uncontrolled angina
* anyone with a known positive cardiac stress test.

Primary outcomes:
measure: Radar blood pressure compared with blood pressure measured by manual auscultation
timeFrame: 3 years
Secondary outcomes:
measure: Radar blood pressure compared with blood pressure measured invasively
timeFrame: 3 years
Other outcomes:
measure: Radar blood pressure compared with oscillometric blood pressure during a cardiac MRI scan
timeFrame: 3 years
measure: Radar blood pressure compared with oscillometric blood pressure during exercise
timeFrame: 3 years
Locations:
city: London
country: United Kingdom
facility: UCL Bloomsbury Centre for Clinical Phenotyping
Study officials:
affiliation: University College, London
name: Gabriella Captur, PhD
role: PRINCIPAL_INVESTIGATOR
References: