Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04449523
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2020-06-17
Brief Title:
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions SILENT2
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SILENT2
Brief Summary:
Arterial Fibrillation AF is well-recognized as a cause for cryptogenic Acute Ischemic Stroke AIS and is associated with Silent Brain Infarction SBI However the role of AF in the formation of lesions SBIs is less well established than its role in AIS and needs clarification
The investigators hypothesize that continuous rhythm monitoring will yield a similar incidence of AF diagnosis in patients with SBI as compared to patients with cryptogenic AIS
The primary objective is to assess the cumulative incidence of AF diagnosis at 24 months in patients with SBI
The investigators hypothesize that continuous rhythm monitoring will yield a similar incidence of AF diagnosis in patients with SBI as compared to patients with cryptogenic AIS
The primary objective is to assess the cumulative incidence of AF diagnosis at 24 months in patients with SBI
Detailed Description:
Arterial Fibrillation AF is well-recognized as a cause for cryptogenic Acute Ischemic Stroke AIS and searched for in clinical practice However although AF is associated with Silent Brain Infarction SBI its role in the formation of these lesions is less well established and needs clarification A multitude of clinical laboratory echocardiographic and electrocardiographic parameters are associated with AF Although no single one of these parameters has sufficient specificity to rule-in AF their combined use may nevertheless help to identify patients with SBI at highest risk for AF The study is expected to provide evidence that long term monitoring in subjects with SBI yields similar rates of AF as in AIS patients
Patients aged 65 years with a presumably silent brain lesion in a brain magnetic resonance imaging fulfilling inclusion criteria and consenting get a subcutaneous implantation of a cardiac monitor Reveal LINQ Data will be directly transferred to the treating physician by the Medtronic MyCareLink Patient Monitor In case of a relevant arrhythmia the respective study site will be informed by the staff of Inselspital Relevant arrhythmias are defined as follows
First episode of atrial fibrillation 30 seconds
Sustained ventricular tachycardia 30 seconds
Sustained supraventricular tachycardia 30 seconds
Asystoly of 6 seconds duration
Atrial fibrillation with pause of 6 seconds duration
Higher degree atrioventricular AV block 3 AV bloc 21 AV conduction 2 AV block type Mobitz
Sustained bradycardia 30 beats per minute 30 seconds It is the responsibility of the respective study sites to take appropriate actions and inform the patients and treating physicians about relevant findings The maximal timeframe from data transmission to data analysis is one week and from data transmission to patient notification two weeks
The expected results of the study would be supportive in introducing long term monitoring to the care pathway in subjects with SBI Since SBI are more prevalent than AIS and current recommendations very restrictive this would have a relevant impact on SBI management
Patients aged 65 years with a presumably silent brain lesion in a brain magnetic resonance imaging fulfilling inclusion criteria and consenting get a subcutaneous implantation of a cardiac monitor Reveal LINQ Data will be directly transferred to the treating physician by the Medtronic MyCareLink Patient Monitor In case of a relevant arrhythmia the respective study site will be informed by the staff of Inselspital Relevant arrhythmias are defined as follows
First episode of atrial fibrillation 30 seconds
Sustained ventricular tachycardia 30 seconds
Sustained supraventricular tachycardia 30 seconds
Asystoly of 6 seconds duration
Atrial fibrillation with pause of 6 seconds duration
Higher degree atrioventricular AV block 3 AV bloc 21 AV conduction 2 AV block type Mobitz
Sustained bradycardia 30 beats per minute 30 seconds It is the responsibility of the respective study sites to take appropriate actions and inform the patients and treating physicians about relevant findings The maximal timeframe from data transmission to data analysis is one week and from data transmission to patient notification two weeks
The expected results of the study would be supportive in introducing long term monitoring to the care pathway in subjects with SBI Since SBI are more prevalent than AIS and current recommendations very restrictive this would have a relevant impact on SBI management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None