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

Atrial Fibrillation Clinical Trial

— Find-AF2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04371055
• Other study ID #: Find-AF 2
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of Leipzig
• Contact: Rolf Wachter, Prof. Dr.
• Phone: +49-341-97-12650
• Email: rolf.wachter[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Embolism
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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)
• Implantable cardiac monitor
Continuous rhythm monitoring using an implantable cardiac monitor
• Standard of care
Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)

Locations

Country	Name	City	State
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 Klinikum Neukölln Berlin	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 Bremen Mitte	Bremen
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	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinikum Höxter	Höxter
Germany	Klinikum Ibbenbüren	Ibbenbüren
Germany	Westpfalz Klinikum GmbH - Standort Kaiserslautern	Kaiserslautern
Germany	Klinikum St. Georg Leipzig	Leipzig
Germany	University of Leipzig, Clinic for Neurology	Leipzig	Saxony
Germany	Städtisches Klinikum Lüneburg gemeinnützige GmbH	Lüneburg
Germany	University of Mainz, Clinic for Neurology	Mainz
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Carl-von-Basedow Klinikum Merseburg	Merseburg
Germany	Klinikum Minden	Minden
Germany	Ökumenisches Hainich Klinikum Mühlhausen	Mühlhausen
Germany	ISD München	München	Bayern
Germany	Universitätsklinikum Münster	Münster
Germany	Klinikum Nürnberg	Nürnberg	Bayern
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study homepage with information for medical experts and the general public