This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Atrial fibrillation is a major cause of stroke, but it can be difficult to catch because it often comes and goes.
The study will include approximately 450 adults who have had a stroke or a transient "mini-stroke" (TIA) within the last two weeks. Participants will be assigned by chance (randomized) to one of two groups:
* Group 1 (Intervention): Participants wear the "ECG247 Smart Heart Sensor." This is a small patch that sticks to the chest and connects to a smartphone. It is worn continuously for up to 14 days, even after leaving the hospital. * Group 2 (Standard Care): Participants receive the standard hospital check-up. This typically involves using a "Holter monitor" (a device with wires and electrodes) for a period of about 24 to 48 hours some time after leaving the hospital.
The main goal is to see if the procedure using the patch is equal to the standard procedure in detecting atrial fibrillation in participants. The study will also measure how quickly doctors can start the correct medication and how easy the patients find the devices to use.
Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, occurring within the last 2 weeks.
Initial evaluation of CT and/or CT angiography and/or MRI supports a diagnosis of TIA or ischemic stroke.
Available smartphone and access to the ECG247-app to be able to participate in the study.
Estimated life span of >6 month
Known AF or atrial flutter prior to inclusion
Concomitant use of anticoagulation therapy or established contraindication to its use. To date this includes apixaban, rivaroxaban, edoxaban, dabigatran, warfarin and indirect thrombin inhibitors (except for short term thrombosis prevention).
Implanted pacemaker, ICD or loop-recorder
>70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound
Parallel
Patch ECG
DeviceThis study aims to evaluate the clinical utility and cost-effectiveness of a novel, continuous patch ECG system (ECG247) initiated in the hospital setting compared to standard care.
Standard Care (in control arm)
DevicePatients in this group receive standard heart rhythm monitoring according to current hospital guidelines.
Detection rate of atrial fibrillation
The detection rate of AF (defined as episodes ≥30 seconds). Analysis will be performed on an intention-to-treat basis, and AF detection will be primarily assessed for its non-inferiority and secondarily for difference in proportions. An interim analysis for efficacy measures will be performed using the O'Brien-Flemming correction for the primary endpoint AF detection rate after 72 and 144 participants in each arm.
Time from enrollment to treatment initiation with anticoagulant medicine
Days from enrollment until AF detection results in change of prophylactic treatment, defined as prescribed anticoagulant medication collected by the patient, retrieved from e-prescription data accessed through the Summary Care Record (Kjernejournal).
Time from enrollment to detection of first AF episode
Time to detection of first episode of atrial fibrillation after hospital admission
Total duration of heart rate monitoring
Total duration of heart rate monitoring, also including an assessment of device signal quality for assessment
Explore the practical utility in regards to validity of results of AF screening after a stroke with a patch ECG
Inter-rater validity of ECG results between the ECG247 algorithm, cardiologists and neurologists
Explore the practical utility of time consumed using AF screening after a stroke with a patch ECG
A suitable number of observations will be performed to evaluate the time needed to complete the patch ECG attachment and inform the patient, interpret the results and follow-up of results
Explore the practical utility and reliability of AF screening after a stroke with a patch ECG
Reliability of the monitoring device in crude versus interpretable monitoring duration in hours. Reliability will be assessed by the study personnel when creating the patch ECG result record. The whole pulse rate strip will be analyzed to identify periods of 1\>h with a lack of signal or reduced signal quality. The total monitoring duration registered by the algorithm in hours versus manual interpretation with readable signal in hours will be evaluated as a percentage: Useable monitoring time/Total monitoring time x 100% = Percentage of useful monitoring.
Explore the practical utility and patient satisfaction of AF screening after a stroke with a patch ECG
Patient Reported Experience Measures (PREMs) to all patients in interventional arm within a month of discharge and within 1 month of Holter completion for control arm, registration of technical problems, allergic reactions to patch, photo of patch placement and registration of patients not considered eligible to the study due to lack of smartphone and other causes not listed in the exclusion/inclusion criteria. PREMS will be reported by a 7 point Likert scale, with higher values indicating a high level of satisfaction.
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