Stroke, cerebrovascular diseases Circulatory System
Conditions
Interventions
The trial will follow a 1:1 randomisation of 150 patients.
The study team have chosen a randomised controlled trial to best compare two groups and avoid any intentional or unintentional bias as best
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Suspected acute ischaemic stroke 2. Suitable for monitoring and anticoagulation 3. Capacity to consent or availability of legal representative
Exclusion criteria
Exclusion criteria: 1. Known AF or admission ECG detects new AF or PAF. 2. Imaging of the brain (CT or MRI) confirming non-ischaemic stroke 3. Currently anticoagulated or has alternative indications for long-term anticoagulation 4. Contraindication to use of long-term anticoagulants 5. Patient unable to return the cardiac monitor to the RVI 6. Use of previous Implantable Loop Recorder for detection of PAF within the last 6 months 7. Dermatological condition or allergy prohibiting use of electrodes/skin adhesives 8. Known pacemaker or other devices that may contraindicate the use of monitoring device 9. Patient and/or relative unable to communicate sufficiently in English where no appropriate translator is available. Secondary check at 14 hours: 1. Patient now for palliation 2. Alternative non-cardioembolic cause for stroke confirmed 3. On review patient was identified as non-stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed using patient medical records at 6 weeks post-discharge: 1. The number of cases of paroxysmal atrial fibrillation (PAF) detected using a revised pathway for cardiac monitoring of rapid fitting and longer-term monitoring as compared with the standard methods 2. The number of patients who commenced long-term anticoagulation as a result of detected PAF based on 24-hour recording versus the active arm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients with PAF lasting more than 30 seconds will be compared in both arms measured using patient medical records at 6 weeks post-discharge 2. The time taken (in hours) from stroke onset to PAF detection in those with positive reports in both arms measured using patient medical records at 6 weeks post-discharge 3. Number of visits, workforce burden and associated costs with each pathway will be compared as a whole measured using patient medical records at one timepoint. The number of visits will be counted and recorded. The length of each visit (minutes) will also be recorded. Additional investigations and the number of these performed at each visit will be recorded. These three factors are added to determine workforce burden and costs according to the NHS national tariff. 4. Projected number of strokes prevented based upon the additional number of patients receiving long-term anticoagulation following PAF detection in both arms measured using patient medical records at one timepoint. To work with health economics to determine this using the latest research on AF prevalence combined with national tariff info. The number of patients receiving long-term anticoagulation will be recorded in each group. Comorbidities, age, and stroke risk factor score CHA2DS2-VASc Score) are all taken into account. | — |
Countries
England, United Kingdom
Outcome results
None listed