Condition category
Circulatory System
Date applied
22/06/2016
Date assigned
29/07/2016
Last edited
14/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Stroke is responsible for around 11% of deaths in the UK. More than 900,000 people live with the after effects of stroke. Care for stroke sufferers is a significant social and economic burden for families, the NHS and wider economy. Atrial Fibrillation is a condition in which the electrical control centre of the heart (sinus node) does not send signals properly, leading to uncoordinated signals causing the heart to beat irregularly and often very fast. People suffering from AF have a much higher risk of developing other problems, such as stroke. Prevention of stroke in people with AF is usually achieved using blood thinning medications, such as warfarin, however this is not always effective and there is a risk of serious bleeding. The risk of stroke also increases as people age. Not all patients with AF have any symptoms and many more patients at risk could be identified if screening for Atrial Fibrillation in the over 65s were made quicker and easier. Currently the best form of diagnosing AF (the 'gold standard') is a 12-lead Electrocardiogram (ECG), which requires 10 electrodes (sticky pads that conduct electricity) to be placed on the chest, arms and legs, to measure electrical activity in the heart. The Rapid Rhythm System is a handset with 6 electrodes, held against a patient’s chest and a 4 electrode chest lead attachment. The Rapid Rhythm System requires less undressing and can be performed seated rather than lying down. This could help make screening for Atrial Fibrillation more practical in GP surgeries. The aim of this study is to find out whether the Rapid Rhythm System is as effective a tool for diagnosing AF as the gold standard.

Who can participate?
All patients over the age of 65 attending participating medical centres.

What does the study involve?
Participants attend one appointment at their local GP surgery. During the visit, they undergo a standard 12 lead ECG as well as testing with the Rapid Rhythm System. Patients diagnosed with Atrial Fibrillation or other heart abnormalities are confirmed by a Cardiologist (heart doctor) and proceed to routine care. The results of the two tests are then compared in order to work out how accurately the Rapid Rhythm System is able to identify AF compared to the gold standard.

What are the possible benefits and risks of participating?
Participants benefit from the opportunity of undergoing screening for AF, which is not normally widely available. Direct risks for patients are limited to the potential for anxiety over procedures, or results, that are common to all health screening activities. GPs will assess patient recruitment lists to identify patients for whom anxieties or burden may be a particular issue.

Where is the study run from?
Swan Lane Medical Centre, Bolton and nine other medical centres in England (UK)

When is the study starting and how long is it expected to run for?
June 2015 to December 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Jonathan Lamb

Trial website

Contact information

Type

Public

Primary contact

Dr Jonathan Lamb

ORCID ID

Contact details

Centre For Primary Care
Institute of Population Health
Willliamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Version 2 1 Date 26.02.16, NIHR i4i II-C1-0412-20002

Study information

Scientific title

A diagnostic accuracy study comparing the use of the Rapid Rhythm System to 12-Lead ECG to identify atrial fibrillation in over 65s in primary care

Acronym

Study hypothesis

The aim of this study is to test the performance of the Rapid Rhythm System against the 'gold standard' 12 lead ECG in identifying Atrial Fibrillation in GP surgeries.

Ethics approval

West Midlands - South Birmingham Research Ethics Committee, 29/02/2016, ref: 16/WM/0022

Study design

Multi-centre cross-sectional diagnostic accuracy study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atrial Fibrillation

Intervention

The study involves screening patients for presence of atrial fibrillation using the Rapid Rhythm System and the current gold standard 12-lead ECG. The study is not randomised and no follow up is required. Patients will be invited to participate from GP practice list search using the FARSITE system, patients may also be opportunistically recruited by their routine primary care team. Both tests will be performed consecutively in either order at the same visit to a local practice. Both index and reference tests produce an ECG trace based on 12 electrodes. Both Rapid Rhythm system and conventional 12-lead ECG will be anonymised and interpreted blind by a panel of two cardiologists, in the event their diagnoses disagree results will be passed to a third cardiologist for interpretation blind to the prior interpretations. ECG results for clinical diagnostic purposes and for feedback to patients will be provided by approved supplier Technomed in a process fully independent of the study ECG interpretation. Any patients with problems identified will proceed to routine treatment.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Diagnostic accuracy of the ECG trace from the Rapid Rhythm System at identifying atrial fibrillation (AF) compared to the ECG trace from the 12-lead is determined through assessing the sensitivity (ability to correctly identify patients with AF) and specificity (ability to correctly identify those without AF) of the RR compared to the Gold Standard 12-lead ECG, based on the diagnosis decisions made by the expert cardiology panel from the ECG traces from each system. Both ECG traces will be taken at the same time point and no follow up is involved.

Secondary outcome measures

Secondary accuracy measures:
Positive and negative predictive values (percentages confirmed by the 12-lead ECG to have/not have AF, out of all those classified as such using the RR).

An additional analysis will be conducted to compare the findings from the RR and 12-lead ECG to any pre-existing diagnoses of AF, taking from each patient’s medical record.

A further analysis will make a comparison between two different configurations for the RR device. The device can be operated as either 8-lead from the handset alone or 12-lead using the handset with chest lead attachment. This is an adjunct technical analysis of device characteristics, not a performance measure. For this purpose the 8-lead data will be extracted from the full 12-lead and results for the two configurations compared using correlational and other analysis to determine the extent of agreement across the variables:
1. Rate
2. R-R interval
3. PR interval
4. QRS duration
5. QT interval
6. P-wave frontal axis
7. QRS-frontal axis
8. T-wave frontal axis
9. R/S amplitude in V1 and V2
10. R/S ratio in V1 and V2

Overall trial start date

01/06/2015

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

All patients over the age of 65, including those with prior atrial fibrillation diagnoses.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Patients with implanted pacemakers, or defibrillators
2. Those unable to provide informed consent
3. Those considered by GPs to be inappropriate (e.g. due to terminal illness)

Recruitment start date

07/10/2016

Recruitment end date

30/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Swan Lane Medical Centre
Swan Lane
Bolton
BL3 6TL
United Kingdom

Trial participating centre

Bodey Medical Centre
Ladybarn Court 28 Ladybarn Lane Fallowfield
Manchester
M14 6WP
United Kingdom

Trial participating centre

Bollington Medical Centre
Wellington Road
Bollington
SK10 5JH
United Kingdom

Trial participating centre

Barlow Medical Centre
828 Wilmslow Road Didsbury
Manchester
M20 2RN
United Kingdom

Trial participating centre

Firsway Health Centre
121 Firsway
Sale
M33 4BR
United Kingdom

Trial participating centre

Minden Family Practices
3rd Floor Moorgate Primary Care Centre 22 Derby Way
Bury
BL9 0NJ
United Kingdom

Trial participating centre

West Timperley Medical Centre
21 Dawson Road West Timperley
Altrincham
WA14 5PF
United Kingdom

Trial participating centre

Bridge House Medical Centre
11 Ladybridge Road Cheadle Hulme
Cheadle
SK8 5LL
United Kingdom

Trial participating centre

Northenden Group Practice
489 Palatine Road Northenden
Manchester
M22 4DH
United Kingdom

Trial participating centre

Woodlands Medical Centre
Chadderton Town Health Centre Middleton Road Chadderton
Oldham
OL9 0LH
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Research Governance
Ethics and Integrity Manager
Floor 2 Christie Building
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Study results will be disseminated though the Atrial Fibrillation Association
2. Planned publication in a high impact specialised medical journal

IPD Sharing plan:
Participant level data will be used in further development of the Rapid Rhythm ECG device and may be commercially sensitive. Participant level data will be held by Rapid Rhythm Ltd. Rapid Rhythm Ltd is a University of Manchester, Central Manchester University Hospitals NHS Foundation Trust (CMFT) spin out company established through NIHR i4i. CMFT and the grant holder Dr Fitzpatrick are minority shareholders in Rapid Rhythm Ltd.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/10/2016: The recruitment dates have been updated from 01/08/2016 - 30/11/2016 to 07/10/2016 - 30/12/2016 and the overall trial end date has been updated from 30/12/2016 to 31/03/2017. 13/10/2016: Eccles Gateway Medical Centre has been removed from the list of trial participating centres and nine additional sites have been added.