NCT04108884Completed
RedStroke - Reducing Europe's Stroke Incidence
RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1019 (actual)
- First submitted
- 26 Sept 2019
- Start date
- 22 Oct 2019
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Heart failure, Stroke, Atrial fibrillation
- NCT number
- NCT04108884
What you commit to
- Study type: Interventional
- Participants enrolled: 1019
- From 22 Oct 2019 to the primary completion date, 18 Jan 2024
- 7 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of Atrial Fibrillation
- cardiac implanted electronic device (ICD or/and PM)
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Other
- current anticoagulation treatment,
- app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other)
- enrollment of the investigator, his/her family members, employees and other dependent persons
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitiy Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| University Medicine Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Ambulantes Herz-Kreislauf-Zentrum Coordinator of this site? Confirm its status | Pasewalk | Germany | Unknown status |
| Asklepeion Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Semmelweis University - Heart and Vascular Center Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| University Maastricht Polikliniek Hart+Vaat Centrum Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Jagiellonian University Medical College Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.