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ECG monitoring to detect atrial fibrillation after stroke

Evaluation of electrocardiographic monitoring strategy to identify atrial fibrillation in patients with recent acute stroke: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97412358
Enrollment
5000
Registered
2010-04-28
Start date
2010-05-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Ischaemic stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

Control: standard care Intervention: two additional 12-lead ECGs plus 3 - 7 days' continuous ECG event monitoring Duration of intervention: 7 days Duration of follow-up: 1 year direct
5 years electronic

Sponsors

NHS Greater Glasgow & Clyde (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of acute ischaemic stroke or confirmed transient ischaemic attack, within one week of symptom onset (participants are of any age and sex) 2. Brain imaging completed prior to enrolment is consistent with acute ischaemic damage and has excluded an alternative cause for symptoms 3. Sinus rhythm on screening ECG 4. Consent to participate from patient or approved proxy

Exclusion criteria

Exclusion criteria: 1. Clinical decision or expressed refusal to consider long term anticoagulation at a future date if cardio-embolism may be diagnosed 2. Pre-morbid condition or concomitant disease that would render subsequent secondary prevention of stroke inappropriate 3. Documented atrial fibrillation in past 4. Known durable cardiac source of embolism (eg mitral stenosis) or left ventricular akinesia, that would represent an indication for anticoagulation 5. Existing treatment with long term anticoagulation 6. Unlikely to be available for completion of study procedures

Design outcomes

Primary

MeasureTime frame
Absolute number of patients with AF or atrial flutter detected within two weeks of stroke.

Secondary

MeasureTime frame
Secondary outcomes: 1. Absolute number of patients with AF or atrial flutter detected within 90 days and one year of stroke 2. Absolute number of patients commenced on oral anticoagulation within two weeks and one year of stroke 3. Marginal cost of investigation 4. Marginal cost of treatment 5. Patient acceptability 6. Time to recognition of AF/flutter Tertiary outcomes: 1. Stroke recurrence within one year 2. Distribution of modified Rankin scale at one year (assessed centrally by recorded interview to ensure objectivity) 3. 'Home time' over 90 days - an objective measure of early functional outcome 4. EQ-5D quality of life at one year (in patients who can complete this, or by proxy) 5. Five-year survival (by flagging with ONS) 6. Predictors of AF amongst eligible patients 7. AF duration 'threshold' for use of anticoagulation

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026