RedStroke - Reducing Europe's Stroke Incidence (RedStroke)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: App measurement; Device: 14 day Holter ECG

• Study Type: Interventional
• Enrollment (Anticipated): 2100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens Eckstein, MD, PhD; Phone Number: 87689 +41 61 32; Email: jens.eckstein@usb.ch
• Study Contact Backup: Name: Aura Winterhalder; Phone Number: 86677 +41 61 32; Email: aura.winterhalder@usb.ch

Study Locations

• Germany
  • Pasewalk, Germany, 17309
    • Recruiting
    • Ambulantes Herz-Kreislauf-Zentrum
    • Contact: Christine Bahr, MD
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Recruiting
      • University Medicine Greifswald
      • Contact: Marcus Dörr, MD, Prof.; Phone Number: +49 3834 86 80510; Email: marcus.doerr@uni-greifswald.de
• Greece
  • Attica
    • Athens, Attica, Greece, 17121
      • Recruiting
      • Asklepeion Hospital
      • Contact: . Athanasios J. Manolis, MD, Prof.; Phone Number: + 30 6944 946394; Email: ajmanol@otenet.gr
• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Semmelweis University - Heart and Vascular Center
    • Contact: Marcell László, MD
• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Recruiting
      • University Maastricht Polikliniek Hart+Vaat Centrum
      • Contact: Dominik Linz, MD PhD
• Poland
  • Lesser Poland
    • Krakow, Lesser Poland, Poland, 31-501
      • Recruiting
      • Jagiellonian University Medical College
      • Contact: Dariusz Dudek, MD PhD Prof.; Phone Number: + 48 12 4247181; Email: mcdudek@cyfronet.pl
• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Recruiting
      • Universitiy Hospital Basel
      • Contact: Thilo Burkard, MD; Phone Number: 87738 +41 61 32; Email: thilo.burkard@usb.ch
      • Contact: Aura Winterhalder; Phone Number: 86677 +41 61 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: App Group; In the app group, if an episode of arrhythmia is detected with the app, the local investigator will contact the respective patient to schedule an appointment for a 14 day Holter ECG.	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; Device: 14 day Holter ECG; 14 day moblie patch Holter ECG for AF confirmation
OTHER: Standard Care Group; The control group will perform the same measurements as the intervention group, with the only difference that a cumulated Portable Document Format (PDF) report is provided after 6 months instead of the immediate feedback in the app group.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Atrial Fibrillation	Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Compliance of patients using the app	Number of patients who regularly use the app according to study instructions	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: European Union; Preventicus GmbH
• Investigators: Study Director: Jens Eckstein, MD, PhD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2019
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): September 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Stroke; Atrial Fibrillation; Screening; Vascular disease; Cardiovascular risk factors; Congestive heart failure; Smartphone App; CHA2DS2-VASc-Score; Outpatient setting
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2019-00908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No