Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation

Leiden University57 enrolled

Overview

The main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Ischemic Stroke Transient Ischemic Attack

Interventions

Single lead ECG deviceDEVICE

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.

7-Day Holter monitor.DEVICE

The Holter is a conventional 7-Day Holter monitor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Regionshospitalet Midtjylland

Herning, Denmark

Reinier de Graaf Hospital

Delft, South Holland, Netherlands

Groene Hart Ziekenhuis

Gouda, South Holland, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

Outcomes

Primary Outcomes

Percentage of detected atrial fibrillation

Time frame: 1 year of follow-up

Secondary Outcomes

Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL

Time frame: 24 hours after cryptogenic stroke

Percentages of atrial ectopy detected on 7-Day Holter monitor

Time frame: 7 days after cryptogenic stroke

Left atrial diameter in cm/m2

Time frame: 24 hours after cryptogenic stroke

Number of participants with a recurrent stroke or TIA as defined in the trial

Time frame: Within one year after cryptogenic stroke

Number of participants with a major bleeding

Time frame: Within one year after cryptogenic stroke

Left atrial volume in mL/m2

Time frame: 24 hours after cryptogenic stroke

Data from ClinicalTrials.gov

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