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

Not Applicable

Terminated

• Conditions: Ischemic Stroke; Atrial Fibrillation; Transient Ischemic Attack
• Interventions: Device: 7-Day Holter monitor.; Device: Single lead ECG device

• Registration Number: NCT02507986
• Lead Sponsor: Leiden University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Study Start: 2016-07-29
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7-Day Holter monitor	7-Day Holter monitor.	This arm will receive a 7-Day Holter monitor directly after randomization.
Single lead ECG device	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.

Primary Outcome Measures

Name	Time	Method
Percentage of detected atrial fibrillation	1 year of follow-up

Secondary Outcome Measures

Name	Time	Method
Number of participants with a recurrent stroke or TIA as defined in the trial	Within one year after cryptogenic stroke
Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL	24 hours after cryptogenic stroke
Left atrial diameter in cm/m2	24 hours after cryptogenic stroke
Number of participants with a major bleeding	Within one year after cryptogenic stroke
Percentages of atrial ectopy detected on 7-Day Holter monitor	7 days after cryptogenic stroke
Left atrial volume in mL/m2	24 hours after cryptogenic stroke

Trial Locations

Locations (7)

Reinier de Graaf Hospital; 🇳🇱 Delft, Zuid-Holland, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Zuid-Holland, Netherlands

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Bronovo ziekenhuis; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Regionshospitalet Midtjylland; 🇩🇰 Herning, Denmark

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Alrijne Hospital; 🇳🇱 Leiderdorp, Zuid-Holland, Netherlands