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

NCT ID: NCT04371055

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Ischemic Stroke; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Risk-adapted ECG monitoring for atrial fibrillation

Intervention Group with high Risk for AF:

Continuous Rhythm Monitoring using an implantable cardiac Monitor

Intervention group with low risk for AF:

7-day Holter ECG at baseline, after 3 and 12 months and then annually until the end of the study or the first occurrence of atrial Fibrillation

Group Type: EXPERIMENTAL

7-day Holter ECG

Intervention Type: OTHER

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)

Implantable cardiac monitor

Intervention Type: OTHER

Continuous rhythm monitoring using an implantable cardiac monitor

Standard of Care

Standard of care rhythm monitoring

Group Type: OTHER

Standard of care

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

Implantable cardiac monitor

Continuous rhythm monitoring using an implantable cardiac monitor

Intervention Type: OTHER

Standard of care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Rolf Wachter

Professor for Clinical and Interventional Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolf Wachter, Prof. Dr.

Role: STUDY_CHAIR

University of Leipzig, Clinic and Policlinis for Cardiology

Klaus Gröschel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Mainz, Clinic and Policlinis for Neurology

Locations

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

Countries

Germany

References

Uhe T, Wasser K, Weber-Kruger M, Schabitz WR, Kohrmann M, Brachmann J, Laufs U, Dichgans M, Gelbrich G, Petroff D, Prettin C, Michalski D, Kraft A, Etgen T, Schellinger PD, Soda H, Bethke F, Ertl M, Kallmunzer B, Grond M, Althaus K, Hamann GF, Mende M, Wagner M, Groschel S, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Intensive heart rhythm monitoring to decrease ischemic stroke and systemic embolism-the Find-AF 2 study-rationale and design. Am Heart J. 2023 Nov;265:66-76. doi: 10.1016/j.ahj.2023.06.016. Epub 2023 Jul 7.

Reference Type: BACKGROUND

PMID: 37422010 (View on PubMed)

Wasser K, Uhe T, Schabitz WR, Kohrmann M, Dichgans M, Brachmann J, Laufs U, Gelbrich G, Petroff D, Prettin C, Michalski D, Pelz J, Kraft A, Etgen T, Soda H, Bethke F, Schellinger PD, Althaus K, Hamann GF, Grond M, Kallmunzer B, Petersen M, Pallesen LP, Ertl M, Zickler P, Poli S, Haeusler KG, Steiner T, Sparenberg P, Kermer P, Kopczak A, Kellert L, Nuckel M, Liman J, Ringleb PA, Mende M, Wagner M, Bochert D, Schnieder M, Amanzada I, Groschel S, Hahn M, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Baseline characteristics of patients with acute ischaemic stroke included in the randomised controlled Find-AF 2 trial. Neurol Res Pract. 2025 Jun 26;7(1):45. doi: 10.1186/s42466-025-00399-8.

Reference Type: DERIVED

PMID: 40571918 (View on PubMed)

Related Links

http://www.find-af2.com

Study homepage with information for medical experts and the general public

Other Identifiers

Find-AF 2

Identifier Type: -

Identifier Source: org_study_id