RedStroke - Reducing Europe's Stroke Incidence

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App measurement

Device

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

Device

14 day moblie patch Holter ECG for AF confirmation

Primary outcomes

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 outcomes

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.
Compliance of patients using the app

Time frame: 6 months

Number of patients who regularly use the app according to study instructions

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

European Union
Preventicus GmbH

Registry information

Official study title

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

Acronym: RedStroke

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Sep 30, 2019
Registry last updated: May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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