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Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study (Find-AF2)

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ClinicalTrials.gov Identifier: NCT04371055
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Rolf Wachter, University of Leipzig

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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Atrial Fibrillation Other: 7-day Holter ECG Other: Implantable cardiac monitor Other: Standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, parallel, multicenter interventional trial with blinded assessment of the primary endpoint
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intensive Heart Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

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

Standard of Care
Standard of care rhythm monitoring
Other: Standard of care
Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)




Primary Outcome Measures :
  1. Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism [ 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 ]
    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.

  2. Primary safety endpoint: 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 ]
    Time until the first haemorrhagic stroke


Secondary Outcome Measures :
  1. 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 the combination of stroke, myocardial infarction and cardiovascular death

  2. 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 any stroke

  3. Time until new onset of AF [ Time Frame: from the date of randomization until the date of first documented AF, assessed up to 60 months ]
    Time until new onset of Atrial Fibrillation

  4. 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 all cause mortality

  5. Time until myocardial infarction [ Time Frame: from the date of randomization until the date of all myocardial infarction, assessed up to 60 months ]
    Time until myocardial infarction

  6. Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16) [ Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms ]
    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.

  7. 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 EQ-5D five dimensional Quality of Life (QoL)

  8. 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 ]
    Changes in the overall QoL visual analog scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371055


Contacts
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Contact: Rolf Wachter, Prof. Dr. +49-341-97-12650 rolf.wachter@medizin.uni-leipzig.de
Contact: Katrin Wasser, PD Dr. med. +49-551-3920-194 k.wasser@med.uni-goettingen.de

Locations
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Germany
University of Leipzig, Clinic for Neurology Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Dominik Michalski, Prof. Dr.         
Contact: Rolf Wachter, Prof. Dr.         
Evangelisches Klinikum Bethel, Klinik für Neurologie Not yet recruiting
Bielefeld, Germany, 33611
Contact: Wolf Rüdiger Schäbitz, Prof. Dr.         
Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie Not yet recruiting
Coburg, Germany, 96450
Contact: Johannes Brachmann, Prof. Dr.         
University of Essen, Clinic for Neurology Not yet recruiting
Essen, Germany, 45147
Contact: Martin Köhrmann, Prof. Dr.         
University of Göttingen, Clinic for Neurology Not yet recruiting
Göttingen, Germany, 37075
Contact: Jan Liman, Prof. Dr.         
University of Mainz, Clinic for Neurology Not yet recruiting
Mainz, Germany, 55131
Contact: Klaus Gröschel, Prof. Dr.         
Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie Not yet recruiting
Sande, Germany, 26452
Contact: Pawel Kermer, Prof. Dr.         
Sponsors and Collaborators
University of Leipzig
Johannes Gutenberg University Mainz
Investigators
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Study Chair: Rolf Wachter, Prof. Dr. University of Leipzig, Clinic and Policlinis for Cardiology
Principal Investigator: Klaus Gröschel, Prof. Dr. University of Mainz, Clinic and Policlinis for Neurology
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Responsible Party: Rolf Wachter, Professor for Clinical and Interventional Cardiology, University of Leipzig
ClinicalTrials.gov Identifier: NCT04371055    
Other Study ID Numbers: Find-AF 2
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: after publication of the major results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rolf Wachter, University of Leipzig:
Atrial Fibrillation
Ischemic Stroke
ECG Monitoring
Secondary Prevention
Additional relevant MeSH terms:
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Atrial Fibrillation
Stroke
Cerebral Infarction
Embolism
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Embolism and Thrombosis