Screening for atrial fibrillation with ECG to reduce stroke

Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) - a feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16939438

Enrollment

4800

Registered

2019-01-29

Start date

2019-02-01

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System Atrial fibrillation

Interventions

Patients will be invited to join the SAFER Study with a Participant Information Sheet and Informed Consent Form from their GP surgery. Consent will be given by returning the consent form or by complet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 65 years (patients) 2. Gender: both males and females

Exclusion criteria

Exclusion criteria: 1. Long-term anticoagulation therapy for stroke prevention. 2. On the palliative care register. 3. Resident in a nursing home.

Design outcomes

Primary

Measure	Time frame
As this is a feasibility study with a large qualitative component, there are a number of outcome measures that are considered primary: 1. Incremental increase in new AF detection rate by number of days screened and by number of times screened per day; measured using a handheld single-lead ECG device (Zenicor) at baseline 2. New AF detection rate, measured using a handheld single-lead ECG device (Zenicor) at baseline 3. % of new AF detected that is persistent versus paroxysmal; measured using a handheld single-lead ECG device (Zenicor) at baseline 4. % of patients with an AF code on the GP record who have confirmed AF from the screening process; measuredusing a handheld single-lead ECG device (Zenicor) at baseline 5. % eligible patients who consent – estimated to be around 50%; measured at baseline 6. % people who consent who are screened in six months – estimated to be around 40% over six months; measured at baseline 7. % people screened who have 2-week paroxysmal AF screening; measured using a handheld single-lead ECG device (Zenicor) at baseline 8. % people whose paroxysmal AF screening includes at least 15 ECG traces; measured using a handheld single-lead ECG device (Zenicor) at baseline 9. % people who have AF identified (subdivided by new/previously known; paroxysmal/ permanent); measured using a handheld single-lead ECG device (Zenicor) and compared to previous medical notes at baseline 10. % people who have AF identified who are reviewed by their GP; measured post-screening 11. % people with AF commenced on anticoagulation (sub-divided by new/previously known; CHA2DS2-Vasc score: 1 or =1); measured post screening 12. % completeness of baseline data from electronic record; measured post screening 13. All of the above criteria in age sub-groups to refine ag	—

Measure

Time frame

As this is a feasibility study with a large qualitative component, there are a number of outcome measures that are considered primary: 1. Incremental increase in new AF detection rate by number of days screened and by number of times screened per day; measured using a handheld single-lead ECG device (Zenicor) at baseline 2. New AF detection rate, measured using a handheld single-lead ECG device (Zenicor) at baseline 3. % of new AF detected that is persistent versus paroxysmal; measured using a handheld single-lead ECG device (Zenicor) at baseline 4. % of patients with an AF code on the GP record who have confirmed AF from the screening process; measuredusing a handheld single-lead ECG device (Zenicor) at baseline 5. % eligible patients who consent – estimated to be around 50%; measured at baseline 6. % people who consent who are screened in six months – estimated to be around 40% over six months; measured at baseline 7. % people screened who have 2-week paroxysmal AF screening; measured using a handheld single-lead ECG device (Zenicor) at baseline 8. % people whose paroxysmal AF screening includes at least 15 ECG traces; measured using a handheld single-lead ECG device (Zenicor) at baseline 9. % people who have AF identified (subdivided by new/previously known; paroxysmal/ permanent); measured using a handheld single-lead ECG device (Zenicor) and compared to previous medical notes at baseline 10. % people who have AF identified who are reviewed by their GP; measured post-screening 11. % people with AF commenced on anticoagulation (sub-divided by new/previously known; CHA2DS2-Vasc score: 1 or =1); measured post screening 12. % completeness of baseline data from electronic record; measured post screening 13. All of the above criteria in age sub-groups to refine ag

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Contacts

Public ContactAndrew Dymond

ad486@medschl.cam.ac.uk+44 (0)1223761457

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026