Atrial FibrillationRedStrokeNCT04108884
RedStroke - Reducing Europe's Stroke Incidence
A study testing App measurement and 14 day Holter ECG in people with Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 7 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- App measurement and 14 day Holter ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,019 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 22 Oct 2019to 18 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Germany2 sites
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Ambulantes Herz-Kreislauf-Zentrum
Pasewalk, 17309
Hungary1 site
Semmelweis University - Heart and Vascular Center
Budapest, 1122
Netherlands1 site
University Maastricht Polikliniek Hart+Vaat Centrum
Maastricht, Limburg, 6200 MD
Poland1 site
Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, 31-501
Switzerland1 site
Universitiy Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- App measurement, 14 day Holter ECG
- Keywords
- Atrial Fibrillation, Smartphone App, CHA2DS2-VASc-Score, Screening, Cardiovascular risk factors, Outpatient setting, Congestive heart failure, Stroke, Diabetes, Vascular disease
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Stroke, Diabetes Mellitus, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App measurementDevice
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 ECGDevice
14 day moblie patch Holter ECG for AF confirmation
| Study group | Role | What they receive |
|---|---|---|
| App Group | Experimental | 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. Receives: Device: App measurement; Device: 14 day Holter ECG |
| Standard Care Group | Other | 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. Receives: Device: App measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Atrial Fibrillation
Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Compliance of patients using the app
Number of patients who regularly use the app according to study instructions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start22 Oct 2019
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomised controlled trial. Patients 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. 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, whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study (6 months after inclusion).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Preventicus GmbH
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, MD, PhD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108884
- Sponsor's protocol ID
- 2019-00908
- Other IDs
- 2019
- Acronym
- RedStroke
- Status last verified
- May 2024
- First submitted
- 26 Sep 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
- ClinicalTrials.gov ID
- NCT04108884
- Acronym / sponsor ID
- RedStroke / 2019-00908
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Smartphone App, CHA2DS2-VASc-Score, Screening, Cardiovascular risk factors, Outpatient setting, Congestive heart failure, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- European Union, Preventicus GmbH
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomised controlled trial. Patients 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. 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, whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study (6 months after inclusion).
| Arm | Type | Receives |
|---|---|---|
| App Group | Experimental | Device: App measurement, Device: 14 day Holter ECGIn 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. |
| Standard Care Group | Other | Device: App measurementThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App measurementApp 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 | App Group, Standard Care Group |
| 14 day Holter ECG14 day moblie patch Holter ECG for AF confirmation | Device | App Group |
Primary outcome
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
2 secondary outcomes
Costs related to the AF screening
Time frame: 6 months
Compliance of patients using the app
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, MD, PhD study director
University Hospital, Basel, Switzerland
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App measurement and 14 day Holter ECG in people with Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Greece, Hungary, Netherlands, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Atrial Fibrillation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.