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RedStroke - Reducing Europe's Stroke Incidence (RedStroke)

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: NCT04108884
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
European Union
Preventicus GmbH
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients.

The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: App measurement Device: 14 day Holter ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomised controlled trial. Patients will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. The only difference between the two groups will be, that patients in the "app" group will be informed by their local PI, if the recordings of the app indicate AF, whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study (6 months after inclusion).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients and study team will remain blind to the assigned groups until the end of the trial. Only in case of a positive app finding, patients and site team will be unblinded for the remaining time of the trial.
Primary Purpose: Screening
Official Title: RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App Group
In the app group, if an episode of arrhythmia is detected with the app, the local investigator will contact the respective patient to schedule an appointment for a 14 day Holter ECG.
Device: App measurement
App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations

Device: 14 day Holter ECG
14 day moblie patch Holter ECG for AF confirmation

Standard Care Group
The control group will perform the same measurements as the intervention group, with the only difference that a cumulated Portable Document Format (PDF) report is provided after 6 months instead of the immediate feedback in the app group.
Device: App measurement
App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations




Primary Outcome Measures :
  1. Prevalence of Atrial Fibrillation [ Time Frame: 6 months ]
    Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group


Secondary Outcome Measures :
  1. Costs related to the AF screening [ Time Frame: 6 months ]
    Health care resource utilization data related to AF diagnosis will be collected for all patients during the study. To evaluate the clinical consequences associated with screening, additional endpoints include the initiation of AF-related therapies including anticoagulants, antiarrhythmic agents or hospitalizations with a primary diagnosis of AF. As a general measure of health care utilization, hospitalization for any cause will also be evaluated.

  2. Compliance of patients using the app [ Time Frame: 6 months ]
    Number of patients who regularly use the app according to study instructions



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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent
  • CHA2DS2-VASc score of 3 and above, if patients are aged under 65 years
  • CHA2DS2-VASc score of 2 and above, if patients are aged 65 years or older

Exclusion Criteria:

  • history of Atrial Fibrillation
  • current anticoagulation treatment,
  • cardiac implanted electronic device (ICD or/and PM)
  • app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other)
  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • enrollment of the investigator, his/her family members, employees and other dependent persons

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): NCT04108884


Contacts
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Contact: Jens Eckstein, MD, PhD +41 61 32 ext 87689 jens.eckstein@usb.ch
Contact: Aura Winterhalder +41 61 32 ext 86677 aura.winterhalder@usb.ch

Locations
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Germany
University Medicine Greifswald Not yet recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Contact: Marcus Dörr, MD, Prof.    +49 3834 86 80510    marcus.doerr@uni-greifswald.de   
Greece
Asklepeion Hospital Not yet recruiting
Athens, Attica, Greece, 17121
Contact: . Athanasios J. Manolis, MD, Prof.    + 30 6944 946394    ajmanol@otenet.gr   
Netherlands
University Maastricht Not yet recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Ulrich Schotten, MD PhD Prof.    +31 43 3881077    Schotten@maastrichtuniversity.nl   
Poland
Jagiellonian University Medical College Not yet recruiting
Krakow, Lesser Poland, Poland, 31-501
Contact: Dariusz Dudek, MD PhD Prof.    + 48 12 4247181    mcdudek@cyfronet.pl   
Serbia
Clinical Centre of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Contact: Svetozar Putnik, MD Prof.    +381 63 7234560    svetozar073@yahoo.com   
Switzerland
Universitiy Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Thilo Burkard, MD    +41 61 32 ext 87738    thilo.burkard@usb.ch   
Contact: Aura Winterhalder    +41 61 32 ext 86677      
United Kingdom
University of Birmingham Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15 2TT
Contact: Paulus Kirchhof, MD PhD Prof.    +44 121 414 7042    p.kirchhof@bham.ac.uk   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
European Union
Preventicus GmbH
Investigators
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Study Director: Jens Eckstein, MD, PhD University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04108884    
Other Study ID Numbers: 2019-00908
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Atrial Fibrillation
Smartphone App
CHA2DS2-VASc-Score
Screening
Cardiovascular risk factors
Outpatient setting
Congestive heart failure
Stroke
Diabetes
Vascular disease
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes