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| Name | Class |
|---|---|
| Johannes Gutenberg University Mainz | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk-adapted ECG monitoring for atrial fibrillation | Experimental | 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 |
|
| Standard of Care | Other | Standard of care rhythm monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-day Holter ECG | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism | The trial will be event driven. The minimum follow-up in each patient is 24 months, but may be followed for up to 60 months. | from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months |
| Primary safety endpoint: Time until the first haemorrhagic stroke | Time until the first haemorrhagic stroke | from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time until the combination of stroke, myocardial infarction and cardiovascular death | Time until the combination of stroke, myocardial infarction and cardiovascular death | from the date of randomization until the date of first documented stroke, the date of myocardial infarction and the date of cardiovascular death, whichever comes first, assessed up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Wachter, Prof. Dr. | University of Leipzig, Clinic and Policlinis for Cardiology | Study Chair |
| Klaus Gröschel, Prof. Dr. | University of Mainz, Clinic and Policlinis for Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISD München | München | Bavaria | Germany | |||
| Klinikum Nürnberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37422010 | Background | 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. | |
| 40571918 |
| Label | URL |
|---|---|
| Study homepage with information for medical experts and the general public | View source |
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after publication of the major results
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Randomised, parallel, multicenter interventional trial with blinded assessment of the primary endpoint
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| Implantable cardiac monitor | Other | Continuous rhythm monitoring using an implantable cardiac monitor |
|
| Standard of care | Other | Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation) |
|
| Time until any stroke | Time until any stroke | from the date of randomization until the date of first documented any stroke, assessed up to 60 months |
| Time until new onset of AF | Time until new onset of Atrial Fibrillation | from the date of randomization until the date of first documented AF, assessed up to 60 months |
| Time until all cause mortality | Time until all cause mortality | from the date of randomization until the date of all cause mortality assessed up to 60 months |
| Time until myocardial infarction | Time until myocardial infarction | from the date of randomization until the date of all myocardial infarction, assessed up to 60 months |
| Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16) | Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16). The SIS-16 ranges from 16 to 80, with higher scores showing better Quality of life. | Mean change from baseline until study end assessed up to 60 months in both study arms |
| Changes in the EQ-5D five dimensional Quality of Life (QoL) | Changes in the EQ-5D five dimensional Quality of Life (QoL) | Mean change from baseline until study end assessed up to 60 months in both study arms |
| Changes in the overall QoL visual analog scale | Changes in the overall QoL visual analog scale | Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life |
| Nuremberg |
| Bavaria |
| 90471 |
| Germany |
| Klinikum Bremen Mitte | Bremen | Free Hanseatic City of Bremen | Germany |
| University of Leipzig, Clinic for Neurology | Leipzig | Saxony | 04103 | 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 | 33611 | Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie | Coburg | 96450 | 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 | 45147 | 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 | 37075 | 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 | 55131 | 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 | 26452 | 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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