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

NCT ID: NCT02507986

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2022-01-04

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.

Conditions

Atrial Fibrillation; Ischemic Stroke; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

7-Day Holter monitor

This arm will receive a 7-Day Holter monitor directly after randomization.

Group Type: ACTIVE_COMPARATOR

7-Day Holter monitor.

Intervention Type: DEVICE

The Holter is a conventional 7-Day Holter monitor.

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.

Group Type: EXPERIMENTAL

Single lead ECG device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

7-Day Holter monitor.

The Holter is a conventional 7-Day Holter monitor.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

Groene Hart Ziekenhuis

OTHER

Sponsor Role: collaborator

Herning Hospital

OTHER

Sponsor Role: collaborator

Alrijne Hospital

OTHER

Sponsor Role: collaborator

Reinier de Graaf Groep

OTHER

Sponsor Role: collaborator

Leiden University

OTHER

Sponsor Role: lead

Responsible Party

Serge A. Trines

S.A.I.P. Trines, Senior Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serge Trines, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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

Alrijne Hospital

Leiderdorp, South Holland, Netherlands

Medisch Centrum Haaglanden

The Hague, South Holland, Netherlands

Bronovo ziekenhuis

The Hague, South Holland, Netherlands

Countries

Denmark; Netherlands

References

Treskes RW, Gielen W, Wermer MJ, Grauss RW, van Alem AP, Dehnavi RA, Kirchhof CJ, van der Velde ET, Maan AC, Wolterbeek R, Overbeek OM, Schalij MJ, Trines SA. Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial. Trials. 2017 Aug 29;18(1):402. doi: 10.1186/s13063-017-2131-0.

Reference Type: DERIVED

PMID: 28851409 (View on PubMed)

Other Identifiers

MOBILE-AF

Identifier Type: -

Identifier Source: org_study_id