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| [ ...Back to search results ] | [ Print-friendly version ] |
| ECG monitoring to detect atrial fibrillation after stroke |
| ISRCTN | ISRCTN97412358 |
| ClinicalTrials.gov identifier | |
| Public title | ECG monitoring to detect atrial fibrillation after stroke |
| Scientific title | Evaluation of electrocardiographic monitoring strategy to identify atrial fibrillation in patients with recent acute stroke: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Intensive investigation for atrial fibrillation amongst patients with acute stroke or confirmed transient ischaemic attack (TIA) who are admitted or initially assessed in sinus rhythm will detect 5% who have unrecognised episodes of atrial fibrillation/flutter; and 3.5% who will be suitable to commence oral anticoagulation, rendering a policy of more intensive investigation cost-effective in the NHS. |
| Lay summary | |
| Ethics approval | Scotland A Research Ethics Committee approved on the 17th August 2009 (ref: 09/MRE00/59) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ischaemic stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/05/2010 |
| Anticipated end date | 31/12/2016 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 5000 |
| 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 |
| Primary outcome measure(s) | Absolute number of patients with AF or atrial flutter detected within two weeks of stroke. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Chief Scientist Office of the Scottish Executive Health Department (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Kennedy R Lees |
| Address |
Acute Stroke Unit & Cerebrovascular Clinic
Western Infirmary 44 Church Street and Cardiovascular & Medical Sciences Faculty of Medicine University of Glasgow |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| k.r.lees@clinmed.gla.ac.uk | |
| Sponsor | NHS Greater Glasgow & Clyde (UK) |
| Address |
Research and Development Central Office
Western Infirmary 1st Floor, Tennent Institute 38 Church Street |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Sponsor website: | http://www.nhsggc.org.uk/r&d |
| Date applied | 18/03/2010 |
| Last edited | 28/04/2010 |
| Date ISRCTN assigned | 28/04/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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