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Contact Information:

Mr Andrew Dymond
+44 (0)1223 761457
safer@medschl.cam.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Screening for atrial fibrillation with ECG to reduce stroke – a randomised controlled trial
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Screening for atrial fibrillation with ECG to reduce stroke – a randomised controlled trial

Not Recruiting

Open to: All Genders

Age: Senior

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Medical Conditions

Atrial fibrillation

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
Atrial fibrillation (AF) is a heart condition that causes an irregular heartbeat. It affects up to 1 in 10 people over the age of 65. AF greatly increases the 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. Researchers are therefore undertaking a large 8-year programme of work to find out if screening for AF in people aged 70 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. This study will address these questions.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2020 31 Jan 2024

Publications

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36691194/ Pilot (added 24/01/2023)2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38670614/ Main study (added 02/05/2024)

Internal Pilot Trial: Participating practices will be randomly allocated to the intervention (AF screening) group or the control group.
Main Trial: Participants will be randomly allocated to the intervention (AF screening) group or control group.
Consented participants in the intervention group will be invited to take part in AF screening (see below for more details). The control group do not receive any interventions. Data collection will be electronic through GP medical notes and NHS Digital and health registry linkage, with an average of 4-year follow-up. Consented participants in the intervention group will be invited to take part in screening for atrial fibrillation. The screening consists of 3 weeks of intermittent ECG screening at home. The screening process will be administered remotely by post/phone. The single-lead ECG recorder (provided by Zenicor, a Swedish commercial partner in the trial) will be posted to the patient with instructions for how to use it. Support will be provided by phone. The participant will be asked to take ECG recordings and to transmit each ECG recording to a remote database (via the mobile phone network) by pressing a button on the recorder. Each ECG records for 30 seconds. The researchers will request ECG traces are recorded four times per day (plus when symptomatic) for 3 weeks. Participants will be asked to return the ECG recorder by post at the end of the screening period. ECGs will be reviewed once the ECG recorder is returned. ECGs tagged as ‘possible AF’ will be reviewed by a trained individual for cases of AF or other important rhythm disturbances. The researchers will send diagnostic results to the practice. The practice will inform all participants of their screening result following their local process for informing patients of test results. Participants are informed that the results of the screening will be made available to their practice by 12 weeks from the date they return the ECG recorder. This timescale is in line with current NHS screening programmes. Participants with confirmed AF will be invited for a consultation with the GP (or other healthcare professional in accordance with local policies) to discuss the diagnosis and the appropriate management including initiation of anticoagulation therapy. Other rhythm abnormalities, in addition to AF, may also be detected although these are not being actively sought. Such ECGs will be reviewed by a trained individual and reported to the GP via the same process as diagnoses of AF outlined above if they are clinically relevant. This completes the participant involvement in the screening process. Baseline and follow-up (approx. annually) data from the GP medical record will be collected in accordance with the consent provided.
Internal Pilot Trial: A random sample of patients will be assessed by postal questionnaire on up to three occasions. Participants from various stages of the study will be invited by the trial team to take part in interviews conducted by telephone. Interviews will be audio recorded.

What are the possible benefits and risks of participating?
Taking part in the study may bring participants a sense of altruism in that it will be the world's largest randomised trial for AF screening. Knowing that the programme aims to prevent strokes and heart attacks in people just like them in the future may have a positive mental effect on the participant. Patients diagnosed with AF will be offered treatment which will greatly reduce their risk of having a stroke or heart attack, and possibly dementia. It is possible that a non-AF clinically significant cardiac rhythm abnormality may be diagnosed, in which case the patient will be referred to their GP for appropriate care - this may include further tests and/or treatment if necessary.

Where is the study run from?
1. NIHR CRN: Eastern
2. NIHR CRN: North East and North Cumbria
3. NIHR CRN: North West Coast
4. NIHR CRN: Yorkshire and Humber
5. NIHR CRN: Greater Manchester
6. NIHR CRN: East Midlands
7. NIHR CRN: West Midlands
8. NIHR CRN: West of England
9. NIHR CRN: Thames Valley and South Midlands
10. NIHR CRN: Kent, Surrey and Sussex
11. NIHR CRN: Wessex
12. NIHR CRN: South West Peninsula
13. NIHR CRN: North Thames
14. NIHR CRN: South London
15. NIHR CRN: North West London

When is the study starting and how long is it expected to run for?
August 2017 to September 2028

Who is funding the study?
NIHR Programme Grant for Applied Research (UK)

Who is the main contact?
Mr Andrew Dymond
SAFER@medschl.cam.ac.uk


_____

Previous plain English summary as of 15/02/2021:

Background and study aims
Atrial fibrillation (AF) is a heart condition that causes an irregular heartbeat. It affects up to 1 in 10 people over the age of 65. AF greatly increases the 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. Researchers are therefore undertaking a large 8-year programme of work to find out if screening for AF in people aged 70 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. This study will address these questions.

Who can participate?
People aged 70 or over

What does the study involve?
Participating practices will be randomly allocated to the intervention (AF screening) group or the control group. Consented participants in the intervention practices will be invited to take part in AF screening (see below for more details). The control group do not receive any interventions. Data collection will be electronic through GP medical notes and NHS Digital and health registry linkage, with an average of 5-year follow-up. Consented participants in intervention practices will be invited to take part in screening for atrial fibrillation. The screening consists of 3 weeks of intermittent ECG screening at home. The screening process will be administered remotely by post/phone to ensure participant safety during the COVID-19 pandemic. The single-lead ECG recorder (provided by Zenicor, a Swedish commercial partner in the trial) will be posted to the patient with instructions for how to use it. Support will be provided by phone. When it is safe to do so, participants requiring additional support with using the ECG recorder may be seen at their GP practice by a member of practice staff. The participant will be asked to take ECG recordings and to transmit each ECG recording to a remote database (via the mobile phone network) by pressing a button on the recorder. Each ECG records for 30 seconds. The researchers will request ECG traces are recorded four times per day (plus when symptomatic) for 3 weeks. Participants will be asked to return the ECG recorder by post at the end of the screening period. ECGs will be reviewed once the ECG recorder is returned. ECGs tagged as ‘possible AF’ will be reviewed by a trained individual for cases of AF or other important rhythm disturbances. The researchers will send diagnostic results to the practice. The practice will inform all participants of their screening result following their local process for informing patients of test results. Participants are informed that the results of the screening will be made available to their practice by 12 weeks from the date they return the ECG recorder. This timescale is in line with current NHS screening programmes. Participants with confirmed AF will be invited to attend a consultation with the GP (or other healthcare professional in accordance with local policies) to discuss the diagnosis and the appropriate management including initiation of anticoagulation therapy. Other rhythm abnormalities, in addition to AF, may also be detected. Such ECGs will be reviewed by a trained individual and reported to the GP via the same process as diagnoses of AF outlined above if they are clinically relevant. This completes the participant involvement in the screening process. Baseline and follow-up (approx. annually) data from the GP medical record will be collected in accordance with the consent provided. A random sample of patients will be assessed by postal questionnaire on up to three occasions. Participants from various stages of the study will be invited by the trial team to take part in interviews, either by telephone or face-to-face. Interviews will be audio recorded.

What are the possible benefits and risks of participating?
Taking part in the study may bring participants a sense of altruism in that it will be the world's largest randomised trial for AF screening. Knowing that the programme aims to prevent strokes and heart attacks in people just like them in the future may have a positive mental effect on the participant. Patients diagnosed with AF will be offered treatment which will greatly reduce their risk of having a stroke or heart attack, and possibly dementia. It is possible that a non-AF clinically significant cardiac rhythm abnormality may be diagnosed, in which case the patient will be referred to their GP for appropriate care - this may include further tests and/or treatment if necessary.

Where is the study run from?
1. NIHR CRN: Eastern
2. NIHR CRN: North East and North Cumbria
3. NIHR CRN: North West Coast
4. NIHR CRN: Yorkshire and Humber
5. NIHR CRN: Greater Manchester
6. NIHR CRN: East Midlands
7. NIHR CRN: West Midlands
8. NIHR CRN: West of England
9. NIHR CRN: Thames Valley and South Midlands
10. NIHR CRN: Kent, Surrey and Sussex
11. NIHR CRN: Wessex
12. NIHR CRN: South West Peninsula
13. NIHR CRN: North Thames
14. NIHR CRN: South London
15. NIHR CRN: North West London

When is the study starting and how long is it expected to run for?
August 2017 to March 2027

Who is funding the study?
NIHR Programme Grant for Applied Research (UK)

Who is the main contact?
Mr Andrew Dymond
SAFER@medschl.cam.ac.uk

_____

Previous plain English summary:

Background and study aims
Atrial fibrillation (AF) is a heart condition that causes an irregular heartbeat. It affects up to 1 in 10 people over the age of 65. AF greatly increases the 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. Researchers are therefore undertaking a large 8-year programme of work to find out if screening for AF in people aged 70 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. This study will address these questions.

Who can participate?
People aged 70 or over

What does the study involve?
Participating practices will be randomly allocated to the intervention (AF screening) group or the control group. Consented participants in the intervention practices will be invited to attend an AF screening visit (see below for more details). The control group do not receive any interventions. Data collection will be electronic through GP medical notes and NHS Digital and health registry linkage, with an average of 5-year follow-up. Consented participants in intervention practices will be invited to take part in screening for atrial fibrillation. The screening will be carried out in two stages: an initial screen at the practice, followed by 3 weeks of intermittent screening at home. A member of staff will assign a single-lead ECG recorder (provided by Zenicor, a Swedish commercial partner in the trial) to the patient and instruct them how to use it. Each ECG records for 30 seconds. The participant will be sent home with the ECG recorder and instructions for use. The participant will be asked to take ECG recordings and to transmit each ECG recording to a remote database (via the mobile phone network) by pressing a button on the recorder. The researchers will request ECG traces are recorded four times per day (plus when symptomatic) for 3 weeks. Participants will be asked to return the ECG recorder to the practice at the end of the screening period. ECGs will be reviewed once the ECG recorder is returned. ECGs tagged as ‘possible AF’ or ‘other deviations’ will be reviewed by a trained individual for cases of AF or other important rhythm disturbances. The researchers will send diagnostic results to the practice. The practice will inform all participants of their screening result following their local process for informing patients of test results. Participants are informed that the results of the screening will be made available to their practice by 12 weeks from the date they return the ECG recorder to the practice. This timescale is in line with current NHS screening programmes. Participants with confirmed AF will be invited to attend an appointment with the GP (or other healthcare professional in accordance with local policies) to discuss the diagnosis and the appropriate management including initiation of anticoagulation therapy. Other rhythm abnormalities, in addition to AF, may also be detected. Such ECGs will be reviewed by a trained individual and reported to the GP via the same process as diagnoses of AF outlined above if they are clinically relevant. This completes the participant involvement in the screening process. Baseline and follow-up (approx. annually) data from the GP medical record will be collected in accordance with the consent provided. A random sample of patients will be assessed by postal questionnaire on up to three occasions. Participants from various stages of the study will be invited by the trial team to take part in interviews, either by telephone or face-to-face. Interviews will be audio recorded.


People aged 70 or over
People aged 70 or over
People aged 70 or over

You can take part if:



You may not be able to take part if:


Current exclusion criteria as of 08/01/2024 to 25/07/2022:1. On anticoagulation therapy2. On the practice palliative care register3. Resident in a nursing or care or residential home4. Consented to another trial that will affect participation in SAFER5. Non-UK resident

_____

Previous exclusion criteria as of 25/07/2022:1. On long-term anticoagulation therapy2. On the practice palliative care register3. Resident in a nursing or care or residential home4. Consented to another trial that will affect participation in SAFER5. Non-UK resident

_____

Previous exclusion criteria:1. Long-term anticoagulation therapy for stroke prevention2. On the palliative care register3. Resident in a nursing/care/residential home


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NIHR CRN: Yorkshire and Humber
    S10 2SB
  • NIHR CRN: North West Coast
    L7 8XP
  • NIHR CRN: Greater Manchester
    M13 9WL
  • NIHR CRN: East Midlands
    LE1 5WW
  • NIHR CRN: West Midlands
    CV3 2TX
  • NIHR CRN: West of England
    BS1 2NT
  • NIHR CRN: Thames Valley and South Midlands
    OX3 9DU
  • NIHR CRN: Eastern
    NR1 1QQ
  • NIHR CRN: Kent, Surrey and Sussex
    ME8 0NZ
  • NIHR CRN: Wessex
    SO30 2UN
  • NIHR CRN: South West Peninsula
    PL6 8BX
  • NIHR CRN: North Thames
    W1T 7HA
  • NIHR CRN: South London
    SE1 9RT
  • NIHR CRN: North West London
    W12 0HT
  • NIHR CRN: North East and North Cumbria
    NE3 3HD

Taking part in the study may bring participants a sense of altruism in that it will be the world's largest randomised trial for AF screening. Knowing that the programme aims to prevent strokes and heart attacks in people just like them in the future may have a positive mental effect on the participant. Patients diagnosed with AF will be offered treatment which will greatly reduce their risk of having a stroke or heart attack, and possibly dementia. It is possible that a non-AF clinically significant cardiac rhythm abnormality may be diagnosed, in which case the patient will be referred to their GP for appropriate care - this may include further tests and/or treatment if necessary.
Taking part in the study may bring participants a sense of altruism in that it will be the world's largest randomised trial for AF screening. Knowing that the programme aims to prevent strokes and heart attacks in people just like them in the future may have a positive mental effect on the participant. Patients diagnosed with AF will be offered treatment which will greatly reduce their risk of having a stroke or heart attack, and possibly dementia. It is possible that a non-AF clinically significant cardiac rhythm abnormality may be diagnosed, in which case the patient will be referred to their GP for appropriate care - this may include further tests and/or treatment if necessary.
Taking part in the study may bring participants a sense of altruism in that it will be the world's largest randomised trial for AF screening. Knowing that the programme aims to prevent strokes and heart attacks in people just like them in the future may have a positive mental effect on the participant. Patients diagnosed with AF will be offered treatment which will greatly reduce their risk of having a stroke or heart attack, and possibly dementia. It is possible that a non-AF clinically significant cardiac rhythm abnormality may be diagnosed, in which case the patient will be referred to their GP for appropriate care - this may include further tests and/or treatment if necessary.

Mr Andrew Dymond
+44 (0)1223 761457
safer@medschl.cam.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Cambridge; NHS Cambridgeshire & Peterborough Integrated Care Board (ICB) and funded by NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0217-20007.



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Read full details for Trial ID: ISRCTN72104369

Or CPMS 43549

Last updated 02 May 2024

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