Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study

Last updated: March 8, 2025
Sponsor: University of Leipzig
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Chest Pain

Blood Clots

Treatment

Implantable cardiac monitor

Standard of care

7-day Holter ECG

Clinical Study ID

NCT04371055
Find-AF 2
  • Ages > 60
  • All Genders

Study Summary

Patients who have suffered a stroke are having an increased risk of having recurrent stroke in the future. This risk of stroke is increased by atrial fibrillation, which often "comes and goes" (called paroxysmal) and hence escapes routine diagnostics. The hypothesis of Find-AF 2 is that enhanced (evaluation in a ECG core lab), prolonged (at least 7 days of rhythm monitoring annually) and intensified (continuous rhythm monitoring in high risk patients) not only finds atrial fibrillation more often, but that changes in therapeutic management (e. g. start of anticoagulation after detection of atrial fibrillation) results in a decrease of cardioembolism (which can be either recurrent stroke or systemic embolism).

To prove this hypothesis, patients will be randomised into two groups: the first group will receive the currently available standard care for patients with stroke. In the second group, cardiac rhythm monitoring adapted to the risk of the occurrence of atrial fibrillation is performed - either with a 7-day long-term ECG (at baseline, after 3 and 12 months and every 12 months thereafter) or with continuous monitoring using an implantable cardiac monitor. If atrial fibrillation is detected, this information will be given to the treating study physician. Any therapeutic decision is at the discretion of the treating physician, but should follow current guidelines.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Recent ischemic stroke (sudden focal neurologic deficit lasting > 24h consistentwith the territory of a major cerebral artery) and/or a corresponding lesion onbrain 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

Exclusion Criteria:

  1. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter onadmission 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 looprecorder, 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 operationor intervention.

  8. History of carotid endarterectomy or percutaneous intervention of cerebral arterywithin 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. fillout the questionnaire due to dementia, language difficulties,...) or participate inthe required tests

  12. participation in other randomised interventional trials

  13. suspected lack of compliance

Study Design

Total Participants: 5229
Treatment Group(s): 3
Primary Treatment: Implantable cardiac monitor
Phase:
Study Start date:
July 07, 2020
Estimated Completion Date:
December 31, 2026

Study Description

The Find AF 2 study will investigate whether intensified rhythm monitoring in patients with recent ischemic stroke leads to a decrease in recurrent thromboembolism (defined as recurrent ischemic stroke or systemic embolism). This will be achieved by identifying patients with paroxysmal atrial fibrillation and subsequently switching secondary prevention therapy from antiplatelet therapy to oral anticoagulation. The intensity of heart rhythm monitoring will be risk-adjusted: Patients with an estimated low risk of atrial fibrillation receive a 7-day Holter ECG, which is repeated after 3 and 12 months and annually thereafter. Patients with a high risk of atrial fibrillation (defined by increased supraventricular ectopic activity) receive continuous ECG monitoring using an implanted loop recorder. The control arm is treated according to local standards, which includes cardiac rhythm monitoring for at least 24 hours according to current guidelines. Prior to randomization, a 24-hour Holter ECG is performed in both study arms, ensuring minimal ECG monitoring for patients in the control arm and allowing risk stratification in the intervention arm. Additional ECG monitoring using stroke telemetry and/or additional Holter ECGs is possible according to local standards, provided it does not exceed 7 days. Patients in both study arms will be followed up for at least 24 months.

It should be noted that this study only provides diagnostic information, the therapeutic decision is left to the treating physician.

Connect with a study center

  • ISD München

    München, Bayern
    Germany

    Site Not Available

  • Klinikum Nürnberg

    Nürnberg, Bayern 90471
    Germany

    Site Not Available

  • University of Leipzig, Clinic for Neurology

    Leipzig, Saxony 04103
    Germany

    Site Not Available

  • Klinikum Altenburger Land

    Altenburg,
    Germany

    Site Not Available

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg,
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Rhön Klinikum Campus Bad Neustadt

    Bad Neustadt An Der Saale,
    Germany

    Site Not Available

  • Sozialstiftung Bamberg; Klinikum am Bruderwald

    Bamberg,
    Germany

    Site Not Available

  • BG Klinikum, Unfall-KH Berlin gGmbH

    Berlin,
    Germany

    Site Not Available

  • Vivantes Klinikum Neukölln Berlin

    Berlin,
    Germany

    Site Not Available

  • Vivantes, Humboldt-Klinikum Berlin

    Berlin,
    Germany

    Site Not Available

  • Vivantes Klinikum Spandau

    Berlin-Spandau,
    Germany

    Site Not Available

  • Evangelisches Klinikum Bethel, Klinik für Neurologie

    Bielefeld, 33611
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn,
    Germany

    Site Not Available

  • Klinikum Bremen Mitte

    Bremen,
    Germany

    Site Not Available

  • Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie

    Coburg, 96450
    Germany

    Site Not Available

  • Klinikum Darmstadt

    Darmstadt,
    Germany

    Site Not Available

  • Städtisches Klinikum Dresden, Standort Friedrichstadt

    Dresden,
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden,
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Site Not Available

  • University of Essen, Clinic for Neurology

    Essen, 45147
    Germany

    Site Not Available

  • Klinikum Frankfurt Höchst

    Frankfurt,
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Klinikum Fulda

    Fulda,
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Gießen,
    Germany

    Site Not Available

  • University of Göttingen, Clinic for Neurology

    Göttingen, 37075
    Germany

    Site Not Available

  • Bezirkskrankenhaus Günzburg

    Günzburg,
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle,
    Germany

    Site Not Available

  • Albertinenkrankenhaus Hamburg

    Hamburg,
    Germany

    Site Not Available

  • Asklepios Klinik Altona Hamburg

    Hamburg,
    Germany

    Site Not Available

  • Asklepios Klinik Wandsbek, Hamburg

    Hamburg,
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Klinikum Höxter

    Höxter,
    Germany

    Site Not Available

  • Klinikum Ibbenbüren

    Ibbenbüren,
    Germany

    Site Not Available

  • Westpfalz Klinikum GmbH - Standort Kaiserslautern

    Kaiserslautern,
    Germany

    Site Not Available

  • Klinikum St. Georg Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Städtisches Klinikum Lüneburg gemeinnützige GmbH

    Lüneburg,
    Germany

    Site Not Available

  • University of Mainz, Clinic for Neurology

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim

    Mannheim,
    Germany

    Site Not Available

  • Carl-von-Basedow Klinikum Merseburg

    Merseburg,
    Germany

    Site Not Available

  • Klinikum Minden

    Minden,
    Germany

    Site Not Available

  • Ökumenisches Hainich Klinikum Mühlhausen

    Mühlhausen,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster,
    Germany

    Site Not Available

  • Klinikum Osnabrück GmbH

    Osnabrück,
    Germany

    Site Not Available

  • Klinikum Passau

    Passau,
    Germany

    Site Not Available

  • Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie

    Sande, 26452
    Germany

    Site Not Available

  • Kreisklinikum Siegen

    Siegen,
    Germany

    Site Not Available

  • Kliniken Südostbayern AG, Klinikum Traunstein

    Traunstein,
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen,
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm,
    Germany

    Site Not Available

  • Helios Dr. Horst Schmidt-Kliniken Wiesbaden

    Wiesbaden,
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg,
    Germany

    Site Not Available

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