Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Background and Rationale Atrial fibrillation (AF) is a major risk factor for ischemic stroke, yet it often goes undetected due to its paroxysmal (intermittent) nature. While guidelines recommend prolonged heart rhythm screening after a stroke of undetermined cause, standard hospital practice often relies on short-term telemetry and ambulatory Holter monitoring. These standard methods can be limited by device availability, bulkiness, and short monitoring duration (typically 24-48 hours), potentially leading to under-diagnosis of AF.
This 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.
Study Design This is a prospective, randomized, parallel-group, open-label (no masking) study conducted at a single stroke center. Approximately 450 eligible patients will be enrolled.
Recruitment and Stratification Patients admitted with ischemic stroke or transient ischemic attack (TIA) within the last two weeks are screened for eligibility, aiming for inclusion within 48 hours of admission. Participants are randomized in a 1:1 ratio to either the intervention arm or the standard care arm. Randomization is stratified by age into three groups: 18-64 years, 65-74 years, and ≥75 years.
Intervention Arm (ECG247 Smart Heart Sensor) Patients in this group will have the ECG247 patch applied to the anterior chest wall while in the hospital.
Control Arm (Standard Care) Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines.
Biomarker Analysis Blood samples will be collected from all participants to analyze N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The study will assess the association between NT-proBNP levels and the detection of silent AF to evaluate its potential for risk stratification.
Outcomes and Follow-up
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm (ECG247 Smart Heart Sensor) | Experimental | Patients in this group will have the ECG247 patch applied to the anterior chest wall while in the hospital.
|
|
| Control Arm (Standard Care) | Other | Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patch ECG | Device | This 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of heart rate monitoring. Will also be registered on follow up after 12 months. |
| 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). | From enrollment until end of follow up (12 months after enrollment). |
| Time from enrollment to detection of first AF episode | Time to detection of first episode of atrial fibrillation after hospital admission | From enrollment up to 1 year |
| Total duration of heart rate monitoring | Total duration of heart rate monitoring, also including an assessment of device signal quality for assessment | From enrollment up to 1 year |
| Numbers of participants with secondary stroke/TIA and/or major bleeding | Assessing secondary stroke and major bleeding at 1 year of follow-up | From enrollment to one-year follow up, assessed at 1-year follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 1 year of recruitment |
| Explore the practical utility of time consumed using AF screening after a stroke with a patch ECG |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Halvor Oeygarden, PhD | Contact | +4747621336 | halvor.oygarden@sshf.no | |
| Ivana Sapina, PhD student | Contact | +47 47311701 | ivana.sapina@sshf.no |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sørlandet Sykehus HF | Recruiting | Kristiansand | 4615 | Norway |
Currently undecided regarding the sharing of IPD. No established formal cooperation agreements with external research groups to date. Any future decision to share data will depend on the establishment of such collaboration agreements in adherence to data protection regulations.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
This is a prospective, randomized, parallel-group, open-label (no masking) screening study.
Not provided
Not provided
Not provided
Not provided
| Standard Care (in control arm) | Device | Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines. |
|
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 |
| After 1 year of recruitment |
| 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. | Assessed at 1 year after enrollment start |
| 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. | Through study completion |
| Diagnostic quality of in-house patch ECG compared to telemetry | Sensitivity and specificity of AF detection in patch ECG compared to concomitant telemetry. Assessment of detection of other dangerous arrhythmias in patch ECG compared to telemetry. Quality of signal from telemetry compared to patch ECG. In the subgroup of patients where patch ECG and telemetry are worn simultaneously, the results of both methods will be cross-validated against each other | From start of enrollment until discharge of last included patient |
| Cost effectiveness of patch ECG compared to standard care | Cost-effectiveness analysis of patch ECG and standard care with the endpoint being reduced secondary stroke | From enrollment until end of follow up. |
| Assess predictors of silent AF | Association between clinical, radiological and laboratory factors (including) NT-pro-BNP level and AF NT-proBNP will be assessed upon inclusion and can be analyzed from blood samples drawn on day 1 after admission. MRI results Echocardiography results CHADSVASC, age, gender, medication used, previous diseases, BMI | From enrollment until end of patient follow-up |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |