SAFER Study
Research type
Research Study
Full title
The SAFER Study - Screening for Atrial Fibrillation with ECG to Reduce stroke - a feasibility study
IRAS ID
256423
Contact name
Jonathan Mant
Contact email
Sponsor organisation
University of Cambridge
Clinicaltrials.gov Identifier
FR16 – project 410, NSPR funding reference
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Atrial fibrillation (AF) is a heart condition that causes irregular heartbeat. It affects up to 1 in 10 people over the age of 65. AF greatly increases risk of stroke, but treatment with blood thinning (“anticoagulant”) medication can stop this happening. About 10% of strokes happen in people unaware they have AF. Detecting AF can be difficult because it often comes and goes, and may not cause symptoms.
Many clinicians think the NHS should promote AF screening. The UK National Screening Committee has highlighted a lack of evidence that detecting AF in people by screening would benefit them.
We are therefore undertaking a large 8-year programme of work to find out if screening for AF in people aged 65 and over does prevent stroke and other problems like heart attacks, does not cause significant harm, and represents good value-for-money for the NHS. The SAFER Study is a feasibility study to inform the development of what will be the world's largest AF screening trial that will address these questions.
The SAFER Study will take place in 12 GP practices in East England who will invite 9,600 patients to take part. Consented participants will be invited to be screened for AF. Participants will use a handheld single-lead ECG recorder to record ECGs at home over a period of 2-4 weeks. The ECGs will be read by a validated computer algorithm, with diagnoses confirmed by a cardiologist. Participants diagnosed with AF will be invited to a GP appointment to discuss treatment with blood thinning (anticoagulant) medication.
As part of this study we will conduct focus groups and interviews with participants to explore their views and beliefs about screening, AF, and their experience of being screened. We will also conduct interviews with GP practice staff to understand the practice experience of screening for AF.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/2066
Date of REC Opinion
20 Dec 2018
REC opinion
Further Information Favourable Opinion