Phase
Condition
Stroke
Blood Clots
Chest Pain
Treatment
Wearable
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participation in Find-AF 2
Randomization in the intervention arm of the Find-AF 2 study and presence of animplanted event recorder (Medtronic Reveal LINQTM Insertable Cardiac Monitor)
Signed informed consent
All inclusion criteria of the Find-AF 2 study are met (according to protocol versionFinal 4.0, dated 08.05.2024): i. Recent symptomatic ischemic stroke within the last 30 days (sudden focalneurologic deficit lasting > 24 h consistent with the territory of a cerebralartery) If the neurologic deficit lasted < 24 h a corresponding lesion* on brainimaging is needed.
ii. Age ≥ 60 years. iii. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symtoms.
iv. Written informed consent
- Corresponding lesion can be an acute lesion on diffusion-weighted magnetic resonance imaging, native computed tomography (CT) or CT perfusion imaging or a recent occlusion or intracranial thrombus on angiography (CTA, MRA, DSA)
Exclusion
Exclusion Criteria:
Expiration of the battery of the event recorder in <3 months
No in ICM data transmission possible (e. g. missing compliance)
Poor ECG data quality according to core lab evaluation (e.g. permanent oversensing),which prevents meaningful evaluation of the event recorder data
Exclusion criteria of the Find-AF 2 study (according to protocol version Final 4.0,dated 08.05.2024): i. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter onadmission ECG.
ii. Current indication or contraindication for oral anticoagulation at randomisation.
iii. Intracerebral bleeding in medical history iv. Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.).
v. Implanted pacemaker device or cardioverter/defibrillator or implanted cardiac monitor.
vi. Patient not willing to be treated with oral anticoagulants vii. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
viii. History of carotid endarterectomy or percutaneous stent intervention of cerebral or cervical artery within the last 30 days.
ix. Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer).
x. Patients under legal supervision or guardianship xi. 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 xii. Participation in other randomized interventional trials xiii. Suspected lack of compliance
Study Design
Study Description
Connect with a study center
Evangelisches Klinikum Bethel, Clinic for Neurology
Bielefeld, 33611
GermanyActive - Recruiting
University of Essen, Clinic of Neurology
Essen, 45147
GermanySite Not Available
University of Göttingen, Clinic for Neurology
Göttingen, 37075
GermanySite Not Available
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120
GermanySite Not Available
University Hospital Leipzig, Clinic for Neurology
Leipzig, 04103
GermanyActive - Recruiting
University of Mainz, Clinic for Neurology
Mainz, 55131
GermanySite Not Available
Klinikum Nürnberg
Nürnberg, 90471
GermanySite Not Available
Kliniken Südostbayern AG, Klinikum Traunstein
Traunstein, 83278
GermanyActive - Recruiting
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