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RedStroke - Reducing Europe's Stroke Incidence

NCT04108884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1019

Last updated 2024-05-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Preventicus GmbH

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Jens Eckstein, MD, PhD · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2024-01-18
Completion
2024-01-18

Countries

  • Germany
  • Greece
  • Hungary
  • Netherlands
  • Poland
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04108884 on ClinicalTrials.gov