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Hidden heart rhythm problems after stroke: can longer monitoring prevent a second stroke?

NCT ID NCT04371055

Prevention Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether intensive heart rhythm monitoring after a stroke can prevent another stroke. People who have had a stroke may have atrial fibrillation, a heart rhythm problem that comes and goes and is easy to miss. Researchers compare standard care with extra monitoring, either a 7-day Holter ECG repeated over time or a small implantable monitor that tracks the heart continuously. If atrial fibrillation is found, doctors can start blood thinners, which may lower the risk of a future stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intensive heart rhythm monitoring using 7-day Holter ECG or an implantable cardiac monitor, compared with standard care
What this could lead to
If it works, this could show that catching hidden atrial fibrillation after a stroke and starting blood thinners reduces the chance of another stroke.
What could go wrong
The trial is large but still experimental. More monitoring may find more atrial fibrillation, but it is not yet proven that this leads to fewer strokes, and implantable monitors carry small risks like infection or discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5,227 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Recent ischemic stroke (sudden focal neurologic deficit lasting \> 24h consistent with the territory of a major cerebral artery) and/or a corresponding lesion on brain imaging within the last 30 days 2. Age ≥ 60 years 3. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symptoms. 4. Written informed consent Exclusion Criteria: 1. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG 2. Current indication or contraindication for oral anticoagulation at randomisation 3. Intracerebral bleeding in medical history 4. Patient scheduled for ECG-monitoring lasting \> 7 days (Holter-ECG, implanted loop recorder, etc.) 5. Implanted pacemaker device or cardioverter/ defibrillator 6. Patient not willing to be treated with oral anticoagulants 7. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention. 8. History of carotid endarterectomy or percutaneous intervention of cerebral artery within the last 30 days. 9. Life expectancy \<1 year for reasons other than stroke (e.g. metastatic cancer) 10. patients under legal supervision or guardianship 11. psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties,...) or participate in the required tests 12. participation in other randomised interventional trials 13. suspected lack of compliance

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Conditions

The condition(s) this trial relates to.

atrial fibrillation ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Ischemic stroke

Contacts and locations

Locations

  • Albertinenkrankenhaus Hamburg

    Hamburg, Germany

  • Asklepios Klinik Altona Hamburg

    Hamburg, Germany

  • Asklepios Klinik Wandsbek, Hamburg

    Hamburg, Germany

  • BG Klinikum, Unfall-KH Berlin gGmbH

    Berlin, Germany

  • Bezirkskrankenhaus Günzburg

    Günzburg, Germany

  • Carl-von-Basedow Klinikum Merseburg

    Merseburg, Germany

  • Evangelisches Klinikum Bethel, Klinik für Neurologie

    Bielefeld, 33611, Germany

  • Helios Dr. Horst Schmidt-Kliniken Wiesbaden

    Wiesbaden, Germany

  • ISD München

    München, Bavaria, Germany

  • Kliniken Südostbayern AG, Klinikum Traunstein

    Traunstein, Germany

  • Klinikum Altenburger Land

    Altenburg, Germany

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, Germany

  • Klinikum Bremen Mitte

    Bremen, Free Hanseatic City of Bremen, Germany

  • Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie

    Coburg, 96450, Germany

  • Klinikum Darmstadt

    Darmstadt, Germany

  • Klinikum Frankfurt Höchst

    Frankfurt, Germany

  • Klinikum Fulda

    Fulda, Germany

  • Klinikum Höxter

    Höxter, Germany

  • Klinikum Ibbenbüren

    Ibbenbueren, Germany

  • Klinikum Minden

    Minden, Germany

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90471, Germany

  • Klinikum Osnabrück GmbH

    Osnabrück, Germany

  • Klinikum Passau

    Passau, Germany

  • Klinikum St. Georg Leipzig

    Leipzig, Germany

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, Germany

  • Kreisklinikum Siegen

    Siegen, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie

    Sande, 26452, Germany

  • Rhön Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, Germany

  • Sozialstiftung Bamberg; Klinikum am Bruderwald

    Bamberg, Germany

  • Städtisches Klinikum Dresden, Standort Friedrichstadt

    Dresden, Germany

  • Städtisches Klinikum Lüneburg gemeinnützige GmbH

    Lüneburg, Germany

  • University of Essen, Clinic for Neurology

    Essen, 45147, Germany

  • University of Göttingen, Clinic for Neurology

    Göttingen, 37075, Germany

  • University of Leipzig, Clinic for Neurology

    Leipzig, Saxony, 04103, Germany

  • University of Mainz, Clinic for Neurology

    Mainz, 55131, Germany

  • Universitätsklinikum Augsburg

    Augsburg, Germany

  • Universitätsklinikum Bonn

    Bonn, Germany

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Germany

  • Universitätsklinikum Erlangen

    Erlangen, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Universitätsklinikum Münster

    Münster, Germany

  • Universitätsklinikum Tübingen

    Tübingen, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Germany

  • Vivantes Klinikum Neukölln Berlin

    Berlin, State of Berlin, Germany

  • Vivantes Klinikum Spandau

    Berlin-Spandau, Germany

  • Vivantes, Humboldt-Klinikum Berlin

    Berlin, Germany

  • Ökumenisches Hainich Klinikum Mühlhausen

    Mühlhausen, Germany

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