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

NCT02507986 | Terminated

• 1 other identifier: MOBILE-AF
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 7

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.

Conditions

Atrial Fibrillation; Ischemic Stroke; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• Percentage of detected atrial fibrillation

  1 year of follow-up

Secondary Outcomes (6)

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

  24 hours after cryptogenic stroke

• Percentages of atrial ectopy detected on 7-Day Holter monitor

  7 days after cryptogenic stroke

• Left atrial diameter in cm/m2

  24 hours after cryptogenic stroke

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

  Within one year after cryptogenic stroke

• Number of participants with a major bleeding

  Within one year after cryptogenic stroke

Study Arms (2)

7-Day Holter monitor

ACTIVE COMPARATOR

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

Device: 7-Day Holter monitor.

Single lead ECG device

EXPERIMENTAL

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

Interventions

Single lead ECG device 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.

Single lead ECG device

7-Day Holter monitor. DEVICE

The Holter is a conventional 7-Day Holter monitor.

7-Day Holter monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University: lead
• Medical Center Haaglanden: collaborator
• Groene Hart Ziekenhuis: collaborator
• Herning Hospital: collaborator
• Alrijne Hospital: collaborator
• Reinier de Graaf Groep: collaborator

Study Sites (7)

Regionshospitalet Midtjylland

Herning, 7400, Denmark

Location

Reinier de Graaf Hospital

Delft, South Holland, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, South Holland, 2803 HH, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Alrijne Hospital

Leiderdorp, South Holland, 2353 GA, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, South Holland, 2512 VA, Netherlands

Location

Bronovo ziekenhuis

The Hague, South Holland, 2597 AX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 28851409 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke; Ischemic Attack, Transient

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Serge Trines, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: S.A.I.P. Trines, Senior Cardiologist

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 24, 2015
• Study Start: July 29, 2016
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

NL (6); DK (1)