Atrial Fibrillation, Cognitive Impairment, Depression, Silent Stroke
Conditions
Keywords
cerebral protection, left atrial appendage occlusion, atrial fibrillation, silent brain ischemia, cognitive impairment, depression
Brief summary
The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.
Detailed description
Introduction: Left atrial appendage occlusion (LAAC) procedure is a method of preventing stroke in patients with atrial fibrillation who cannot use anticoagulants. The number of patients undergoing LAAC treatment tends to increase. LAAC procedures effectively reduce the number of strokes, with a significant reduction in the risk of bleeding compared to oral anticoagulants. However, although LAAC treatments alone have a low risk of perioperative stroke, some patients may experience incidents of silent brain ischemia (SBI). The distant effect of SBI may be cognitive deterioration, the onset of dementia syndromes, as well as depression. Purpose of the study: The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation on the risk of perioperative SBI and associated cognitive impairment and depression. Methodology: The planned study is a prospective, multicentre, randomized, and double-blind intervention trial. Neuroprotection introduced from arterial access will be used in the LAAC treatment study group. In the control group, LAAC treatments will be performed without neuroprotection. Two hundred forty patients are planned to be enrolled with indications for stroke prevention due to atrial fibrillation. The analysis will include data obtained from DW MRI images, neurological evaluation results along with NIHSS-scale scores, results of cognitive evaluation tests (MoCA, COWAT, TMT A&B), and test of mood disorders (HADS Scale), as well as results of the EQ-5D-5L quality of life assessment questionnaire. It is planned to observe patients participating in the study for 24 months after LAAC procedure.
Interventions
PROCEDURELAAC procedure with the use of transcatheter cerebral protection system
After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.
PROCEDURELAAC procedure without the use of transcatheter cerebral protection system
Only the aortography through radial access will be done before accessing the left atrium.
Sponsors
Leszek Giec Upper-Silesian Medical Centre
Medical University of Silesia
Biostat Sp. z o.o.
Silesian Centre for Heart Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In order to blind the radial artery will also be punctured in control group and an aortography will be performed. Researchers participating in the randomization of patients and in the procedure will not be included in the remaining stages of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 Years and older 2. Subject able to provide signed informed consent. 3. Documented permanent, persistent, or paroxysmal atrial fibrillation 4. CHA2DS2VASc risk of stroke ≥2 5. At least one of the following criteria: 1. Contraindications to the use of anticoagulants, 2. HSBLED bleeding risk ≥3
Exclusion criteria
1. Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder 2. History of ischemic stroke 3. Chronic abuse of alcohol or any other psychoactive substances except for nicotine 4. long-term therapy with benzodiazepines 5. The use of antidepressants in 3 months prior inclusion. 6. Previous infections of the central nervous system, including neuroborreliosis 7. Parkinson's disease 8. Huntington's chorea 9. Creutzfeld-Jakob disease 10. Pick's disease 11. Significant atherosclerosis of the cephalic arteries (\> 70% LCCA or the brachiocephalic trunk) 12. Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above 13. Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale 14. Presence of a thrombus or tumours of a different nature in the left atrium or its ear 15. Presence of a thrombus in the left ventricle 16. Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage 17. The presence of mechanical heart valve prostheses 18. The state after the operative closure of the defect in the atrial septum 19. Condition after closing the defect in the interatrial septum with the use of occluders 20. Active infective endocarditis 21. Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS) 22. Status after oesophagal surgery 23. Esophageal diverticula 24. Esophageal varices\> grade 3 25. Allergic to contrast agents 26. A contraindication to use antiplatelet drugs 27. Diagnosis of neoplastic disease with estimated survival beyond 1 year 28. Clininally evident hypothyroidism and hyperthyroidism 29. Klaustrofobia 30. Pregnancy 31. AIDS 32. Participation in other drug research studies 33. The presence of circumstances or any medical condition the Investigator considers problematic for subject inclusion, or test results that may couse problems to provide reliable, acurate to interpretation results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of silent cerebral ischemia (SBI) foci | change in the period up to 24 months | number of SBI foci in DW MRI of the brain |
| Change in volume of silent cerebral ischemia (SBI) foci | change in the period up to 24 months | volume SBI foci in DW MRI of the brain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deterioration of cognitive functions | prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months | Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value \<26) |
| Development of dementia | prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months | diagnosis made by a specialist neurologist |
| Occurrence of depressive disorders | prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months | Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder |
| Presence of embolic material in the filters of the neuroprotection device | during LAAC procedure | — |
Countries
Poland
Contacts
Primary ContactWitold A Streb, Ph.D.
Outcome results
None listed