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ACTIVE NOT RECRUITING
NCT04371055
NA

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

Sponsor: University of Leipzig

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5227

Start Date

2020-07-07

Completion Date

2026-12-31

Last Updated

2025-06-04

Healthy Volunteers

No

Interventions

OTHER

7-day Holter ECG

7-day Holter ECG at baseline and after 3 and 12 months and then annually until the end of the study or the first (in patients with low risk of atrial fibrillation)

OTHER

Implantable cardiac monitor

Continuous rhythm monitoring using an implantable cardiac monitor

OTHER

Standard of care

Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)

Locations (52)

ISD München

München, Bavaria, Germany

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

Klinikum Bremen Mitte

Bremen, City state Bremen, Germany

University of Leipzig, Clinic for Neurology

Leipzig, Saxony, Germany

Vivantes Klinikum Neukölln Berlin

Berlin, State of Berlin, Germany

Klinikum Altenburger Land

Altenburg, Germany

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Sozialstiftung Bamberg; Klinikum am Bruderwald

Bamberg, Germany

BG Klinikum, Unfall-KH Berlin gGmbH

Berlin, Germany

Vivantes, Humboldt-Klinikum Berlin

Berlin, Germany

Vivantes Klinikum Spandau

Berlin-Spandau, Germany

Evangelisches Klinikum Bethel, Klinik für Neurologie

Bielefeld, Germany

Universitätsklinikum Bonn

Bonn, Germany

Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie

Coburg, Germany

Klinikum Darmstadt

Darmstadt, Germany

Städtisches Klinikum Dresden, Standort Friedrichstadt

Dresden, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

University of Essen, Clinic for Neurology

Essen, Germany

Klinikum Frankfurt Höchst

Frankfurt, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Klinikum Fulda

Fulda, Germany

Universitätsklinikum Gießen und Marburg GmbH

Giessen, Germany

University of Göttingen, Clinic for Neurology

Göttingen, Germany

Bezirkskrankenhaus Günzburg

Günzburg, Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, Germany

Albertinenkrankenhaus Hamburg

Hamburg, Germany

Asklepios Klinik Altona Hamburg

Hamburg, Germany

Asklepios Klinik Wandsbek, Hamburg

Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Klinikum Höxter

Höxter, Germany

Klinikum Ibbenbüren

Ibbenbueren, Germany

Klinikum St. Georg Leipzig

Leipzig, Germany

Städtisches Klinikum Lüneburg gemeinnützige GmbH

Lüneburg, Germany

University of Mainz, Clinic for Neurology

Mainz, Germany

Carl-von-Basedow Klinikum Merseburg

Merseburg, Germany

Klinikum Minden

Minden, Germany

Ökumenisches Hainich Klinikum Mühlhausen

Mühlhausen, Germany

Universitätsklinikum Münster

Münster, Germany

Klinikum Osnabrück GmbH

Osnabrück, Germany

Klinikum Passau

Passau, Germany

Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie

Sande, Germany

Kreisklinikum Siegen

Siegen, Germany

Kliniken Südostbayern AG, Klinikum Traunstein

Traunstein, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Helios Dr. Horst Schmidt-Kliniken Wiesbaden

Wiesbaden, Germany

Universitätsklinikum Würzburg

Würzburg, Germany