Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation (MOBILE-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507986
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Medical Center Haaglanden
Groene Hart Ziekenhuis
Herning Hospital
Alrijne Hospital
Reinier de Graaf Groep
Information provided by (Responsible Party):
Serge A. Trines, Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ischemic Stroke Transient Ischemic Attack Device: Single lead ECG device Device: 7-Day Holter monitor. Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage of detected atrial fibrillation [ Time Frame: 1 year of follow-up ]

Secondary Outcome Measures :
  1. Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL [ Time Frame: 24 hours after cryptogenic stroke ]
  2. Percentages of atrial ectopy detected on 7-Day Holter monitor [ Time Frame: 7 days after cryptogenic stroke ]
  3. Left atrial diameter in cm/m2 [ Time Frame: 24 hours after cryptogenic stroke ]
  4. Number of participants with a recurrent stroke or TIA as defined in the trial [ Time Frame: Within one year after cryptogenic stroke ]
  5. Number of participants with a major bleeding [ Time Frame: Within one year after cryptogenic stroke ]
  6. Left atrial volume in mL/m2 [ Time Frame: 24 hours after cryptogenic stroke ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507986


Contacts
Layout table for location contacts
Contact: Serge Trines, MD, PhD +31 71 526 3928 s.a.i.p.trines@lumc.nl

Locations
Layout table for location information
Denmark
Regionshospitalet Midtjylland Not yet recruiting
Herning, Denmark, 7400
Contact: Willem Gielen, MD, PhD       willem@gielen.dk   
Principal Investigator: Willem Gielen, MD         
Netherlands
Reinier de Graaf Hospital Recruiting
Delft, Zuid-Holland, Netherlands
Contact: E Ronner, MD, PhD         
Medisch Centrum Haaglanden Recruiting
Den Haag, Zuid-Holland, Netherlands, 2512 VA
Contact: Robert Grauss, MD, PhD       grauss@gmail.com   
Principal Investigator: Robert Grauss, MD, PhD, MSc         
Bronovo ziekenhuis Recruiting
Den Haag, Zuid-Holland, Netherlands, 2597 AX
Contact: Anouk van Alem, MD, PhD       a.vanalem@bronovo.nl   
Principal Investigator: Anouk van Alem, MD, PhD         
Principal Investigator: Suzanne Langerak, MD, PhD         
Groene Hart Ziekenhuis Not yet recruiting
Gouda, Zuid-Holland, Netherlands, 2803 HH
Contact: Reza Alizadeh Dehnavi, MD, PhD       r.alizadeh_dehnavi@lumc.nl   
Principal Investigator: Reza Alizadeh Dehnavi, MD, PhD         
Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: Serge Trines, MD, PhD    +31 71 526 3928    S.A.I.P.Trines@lumc.nl   
Sub-Investigator: Roderick Treskes, BSc         
Sub-Investigator: Enno van der Velde, MSc, PhD         
Sub-Investigator: Marieke Wermer, MD, PhD         
Sub-Investigator: Onno Overbeek, MD, PhD         
Sub-Investigator: Ron Wolterbeek, MD, PhD         
Sub-Investigator: Martin-Jan Schalij, MD, PhD         
Principal Investigator: Serge Trines, MD, PhD         
Alrijne Hospital Recruiting
Leiderdorp, Zuid-Holland, Netherlands, 2353 GA
Contact: Charles Kirchhof, MD, PhD         
Sponsors and Collaborators
Leiden University Medical Center
Medical Center Haaglanden
Groene Hart Ziekenhuis
Herning Hospital
Alrijne Hospital
Reinier de Graaf Groep
Investigators
Layout table for investigator information
Principal Investigator: Serge Trines, MD, PhD Leiden University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Serge A. Trines, S.A.I.P. Trines, Senior Cardiologist, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02507986     History of Changes
Other Study ID Numbers: MOBILE-AF
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Ischemic Attack, Transient
Atrial Fibrillation
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Ischemia