Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation
Palabras clave
Abstracto
Descripción
Rationale: A standard work-up of stroke patients to identify a cause of stroke consists of Computed Tomography (CT), CT angiography of head and neck arteries, transthoracic echocardiography, 12-lead 10-seconds electrocardiogram (ECG), blood tests and 24-hour ECG monitoring. A stroke is called "cryptogenic" if no cause can be determined after standard work-up. Current detection of atrial fibrillation (AF) after stroke is 2.0%. Recent studies revealed that prolonged monitoring yields higher percentages of detected AF (12.0%). Devices used in these trials suffer from drawbacks. The investigators' hypothesis is that a new, smartphone compatible device, producing a single lead ECG (single lead ECG device), can be used for prolonged ECG monitoring in cryptogenic stroke patients.
Objective: The main objective of this study is to compare the incidence of detected AF in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
Study design: A multicenter randomized trial. Study population: Cryptogenic stroke patients admitted to a hospital participating in the study. The calculated sample size is 200 (100 per arm).
Intervention: After inclusion, patients will be randomized to either a single lead ECG device or a 7-Day Holter Monitor.
Main study parameters/endpoints: The main endpoint will be the percentage of detected atrial fibrillation in both the single lead ECG device group and the 7-Day Holter group after one year.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both devices are battery powered and electrically safe. Patients face a 2-3% risk that AF is detected false-positively; this might lead to incorrect oral anticoagulation (OAC) prescription. However, a potential benefit of the investigators' study is that if AF is detected and treated with OAC, this significantly reduces the chance of recurrent stroke.
fechas
| Verificado por última vez: | 07/31/2019 |
| Primero enviado: | 07/14/2015 |
| Inscripción estimada enviada: | 07/21/2015 |
| Publicado por primera vez: | 07/23/2015 |
| Última actualización enviada: | 08/20/2019 |
| Última actualización publicada: | 08/21/2019 |
| Fecha de inicio real del estudio: | 06/30/2016 |
| Fecha estimada de finalización primaria: | 06/30/2020 |
| Fecha estimada de finalización del estudio: | 06/30/2021 |
Condición o enfermedad
Intervención / tratamiento
Device: Single lead ECG device
Device: 7-Day Holter monitor
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: 7-Day Holter monitor This arm will receive a 7-Day Holter monitor directly after randomization. | Device: 7-Day Holter monitor The Holter is a conventional 7-Day Holter monitor. |
| Experimental: Single lead ECG device This arm will be asked to take a single lead ECG two times per day and in case of complaints with a single lead ECG device. | Device: Single lead ECG device The single lead ECG device is a smartphone compatible handheld device that produces a single lead ECG after 30 seconds of measurement. It is non-invasive, electrically safe and easy to use. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke. - Ischemic stroke is defined as an episode of transient or neurological dysfunction caused by focal brain or retinal ischemia with recent infarction on imaging - A TIA is defined as transient episode of neurologic dysfunction typically lasting less than one hour caused by focal brain or retinal ischemia without recent infarction on imaging. Exclusion Criteria: - Known etiology of TIA or ischemic stroke - TIA or stroke caused by spinal ischemia - TIA only presenting with non-localising symptoms - Uncertainty about the diagnosis of TIA because of unclear clinical symptoms - Myocardial infarction <6 months before stroke - Coronary Artery Bypass Grafting <6 months before stroke - Severe valvular heart disease - Documented history of atrial fibrillation or atrial flutter - Permanent indication for oral anticoagulation at enrolment - Patient has permanent OAC contraindication - Patient is included in another randomized trial - Left ventricular aneurysm on echocardiography - Thrombus on echocardiographyRenal dysfunction (creatinine clearance <30 mL/min/1.73m2) - Patient has life expectancy of <1 year - Patient is not willing to sign the informed consent form - Patient is <18 years of age - Patient is considered an incapacitated adult - Patient is not in possession of a smartphone with Android Operating System (OS) or iOS. |
Salir
Medidas de resultado primarias
1. Percentage of detected atrial fibrillation [1 year of follow-up]
Medidas de resultado secundarias
1. Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL [24 hours after cryptogenic stroke]
2. Percentages of atrial ectopy detected on 7-Day Holter monitor [7 days after cryptogenic stroke]
3. Left atrial diameter in cm/m2 [24 hours after cryptogenic stroke]
4. Number of participants with a recurrent stroke or TIA as defined in the trial [Within one year after cryptogenic stroke]
5. Number of participants with a major bleeding [Within one year after cryptogenic stroke]
6. Left atrial volume in mL/m2 [24 hours after cryptogenic stroke]
