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

N/AActive Not RecruitingNCT04371055

University of Leipzig5,227 enrolled

Overview

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (52)

ISD München

München, Bavaria, Germany

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

Klinikum Bremen Mitte

Bremen, Free Hanseatic City of Bremen, Germany

University of Leipzig, Clinic for Neurology

Leipzig, Saxony, Germany

Vivantes Klinikum Neukölln Berlin

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months

Secondary Outcomes

Time until the combination of stroke, myocardial infarction and cardiovascular death

Time frame: 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

Time until any stroke

Time frame: 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

Time frame: from the date of randomization until the date of first documented AF, assessed up to 60 months

Time until all cause mortality

Time frame: from the date of randomization until the date of all cause mortality assessed up to 60 months

Time until myocardial infarction

Time frame: 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.

Time frame: 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)

Time frame: Mean change from baseline until study end assessed up to 60 months in both study arms

Changes in the overall QoL visual analog scale

Time frame: 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