RedStroke - Reducing Europe's Stroke Incidence (RedStroke)

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    2100
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 29 May 2022
electrocardiogram
stroke
holter monitor
fibrillation
vascular disease

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.

Details
Condition Atrial Fibrillation
Treatment App measurement, 14 day Holter ECG
Clinical Study IdentifierNCT04108884
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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