RedStroke - Reducing Europe's Stroke Incidence

Atrial Fibrillation Clinical Trial

— RedStroke  

Official title:

RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108884
• Other study ID #: 2019-00908
• Status: Completed
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: January 18, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1019
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
• 14 day Holter ECG
14 day moblie patch Holter ECG for AF confirmation

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald	Mecklenburg-Vorpommern
Germany	Ambulantes Herz-Kreislauf-Zentrum	Pasewalk
Greece	Asklepeion Hospital	Athens	Attica
Hungary	Semmelweis University - Heart and Vascular Center	Budapest
Netherlands	University Maastricht Polikliniek Hart+Vaat Centrum	Maastricht	Limburg
Poland	Jagiellonian University Medical College	Krakow	Lesser Poland
Switzerland	Universitiy Hospital Basel	Basel	Basel-Stadt

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	European Union, Preventicus GmbH

Countries where clinical trial is conducted

Germany,  Greece,  Hungary,  Netherlands,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Atrial Fibrillation	Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group	6 months
Secondary	Costs related to the AF screening	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.	6 months
Secondary	Compliance of patients using the app	Number of patients who regularly use the app according to study instructions	6 months