Clinical trial NCT03813446: Detection of Heart Rhythm and BP With RhythmPadBP
Official title: A Study to Evaluate the Effectiveness of a Novel Device, the RhythmPadBP, in Accurately Detecting Heart Rhythm and Recording Blood Pressure Simultaneously
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Cardiocity Limited
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending for routine 12-lead ECG, referred by the primary care physician and also patients attending cardiology department at Ashford \& St Peters Hospitals NHS Foundation Trust, Chertsey

Brief summary: This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.

Detailed description: Normally the way a doctor will assess the rhythm of the heart involves asking for an electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair. 10 different leads are attached to stickers that are placed on the chest, and other parts of the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a cuff around the arm and inflating it to enough to measure the BP. The reading is then displayed on a monitor. This can sometimes be uncomfortable and is often time consuming, particularly in busy clinical settings.

Recent advances in technology however have given us different ways of gaining some of the same information given by a 12 lead ECG and the standard BP apparatus, using much easier to use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a device where participants can record the underlying heart rhythm and BP readings simply by placing palms of both hands on the device. This device does not require removal of clothing or placing a BP cuff around arm and so the readings can be gained more rapidly and with greater convenience.

Investigators propose to test this device to assess how accurately it recognises the most common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the blood pressure. This will help to identify AF and any difference of BP in both arms.

AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to increased risk of cardiovascular and cerebrovascular disease. If investigators find that this device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF and BP discrepancies on both sides.

Eligibility criteria: Inclusion Criteria:

1. Age greater or equal to 18 years
2. Able to consent
3. No known allergies to the metal or any component used in the RhythmPadBP

Exclusion Criteria:

1. Age less than 18 years
2. Not able to consent
3. Allergies to the metal or any component of the RhythmPadBP device
4. Active skin conditions affecting the hands, i.e. burns, infections
5. In-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with the ECG recording.

Primary outcomes:
measure: Diagnosis of Atrial Fibrillation
timeFrame: 18 months
Secondary outcomes:
measure: Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings
timeFrame: 18 months
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: Ashford and St Peters NHS Trust
state: Surrey
Study officials:
affiliation: Ashford and St Peter's Hospitals NHS Foundation Trust
name: Riyaz A Kaba, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
References: