RedStroke - Reducing Europe's Stroke Incidence

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04108884
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Study Start: 2019-10-22
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1019

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of Atrial Fibrillation	6 months	Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group

Secondary Outcome Measures

Name	Time	Method
Compliance of patients using the app	6 months	Number of patients who regularly use the app according to study instructions
Costs related to the AF screening	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.

Trial Locations

Locations (7)

University Medicine Greifswald; 🇩🇪 Greifswald, Mecklenburg-Vorpommern, Germany

Ambulantes Herz-Kreislauf-Zentrum; 🇩🇪 Pasewalk, Germany

Asklepeion Hospital; 🇬🇷 Athens, Attica, Greece

Semmelweis University - Heart and Vascular Center; 🇭🇺 Budapest, Hungary

University Maastricht Polikliniek Hart+Vaat Centrum; 🇳🇱 Maastricht, Limburg, Netherlands

Jagiellonian University Medical College; 🇵🇱 Krakow, Lesser Poland, Poland

Universitiy Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland