Performance of RapidRhythm for Atrial Fibrillation in Primary Care V1

  • Research type

    Research Study

  • Full title

    A diagnostic accuracy study comparing the performance of Rapid Rhythm to 12 Lead ECG in identification of atrial fibrillation in patients aged over 65 in primary care

  • IRAS ID

    159461

  • Contact name

    April Lockyer

  • Contact email

    research.governance@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • ISRCTN Number

    ISRCTN12144707

  • Clinicaltrials.gov Identifier

    II-C1-0412-20002, NIHRi4i Challenge Awards Call 1 Stage 2 11/06/2012

  • Duration of Study in the UK

    0 years, 5 months, 30 days

  • Research summary

    Stroke is responsible for around 11% of deaths in the UK. More than 900,000 people live with the after effects of stroke. Care is a significant social and economic burden for families, the NHS and wider economy. \n\nAtrial Fibrillation is a condition that causes an irregular heart rate and identifies a high risk of stroke. Prescribing ‘blood-thinning’ medications such as warfarin can reduce risk of stroke. Risk of stroke increases with age. However, not all patients have symptoms and many more patients at risk could be identified if screening for Atrial Fibrillation in the over 65s were made quicker and easier.\n\nCurrently the best form of diagnosis (the ’gold standard’) is a 12-lead Electrocardiogram (ECG) requiring 10 electrodes 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.\n\nThis research project will test the performance of the Rapid Rhythm System against the ’gold standard’ 12 lead ECG in identifying Atrial Fibrillation in GP surgeries. A second study will test the effectiveness of Rapid Rhythm in patients with known Atrial Fibrillation in Hospital settings.\n\nGPs will invite patients over the age of 65 to take part in the study at a local GP practice.\n\n1000 patients will attend one appointment of around 30 minutes at local GP surgeries, where they will be tested for Atrial Fibrillation using 12-lead ECG and Rapid Rhythm.\n\nPatients diagnosed with Atrial Fibrillation or other heart abnormalities will be confirmed by a Cardiologist and proceed to routine care.

  • REC name

    West Midlands - South Birmingham Research Ethics Committee

  • REC reference

    16/WM/0022

  • Date of REC Opinion

    29 Feb 2016

  • REC opinion

    Further Information Favourable Opinion