Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)
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|ClinicalTrials.gov Identifier: NCT04449523|
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
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.
|Condition or disease|
|Silent Stroke Silent Cerebral Infarct Fibrillation|
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; 2:1 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 Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2025|
- Cumulative incidence of Arterial Fibrillation (AF) diagnosis over a median of 24 months [ Time Frame: From day 0 to 24 months after inclusion ]Only adjudicated events will be used for the analysis. An AF episode is defined as lasting more than 30 seconds. A diagnosis of atrial flutter will also be considered as a primary endpoint.
- Time to first diagnosis of AF (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hour) [ Time Frame: From day 0 to 24 months after inclusion ]
- Burden of AF [ Time Frame: From day 0 to 24 months after inclusion ]The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring. AF burden will be calculated on a monthly basis.
- Time to composite of first diagnosis of AF, stroke and death. [ Time Frame: From day 0 to 24 months after inclusion ]
- Incidence of AF diagnosis according to Silent Brain Infarction (SBI) neuroradiological appearance (subcortical small vessel versus embolic pattern involving grey matter) and SBI fulfilling ESUS criteria versus lacunar type. [ Time Frame: From day 0 to 24 months after inclusion ]Embolic stroke of undetermined source (ESUS)
- Start of oral anticoagulation therapy at 24 months. [ Time Frame: At 24 months ]
- Stroke at 24 months [ Time Frame: At 24 months ]
- Mortality at 24 months [ Time Frame: At 24 months ]
- Prevalence of other possible etiologies for SBI according to a modified TOAST-classification (large artery disease, small artery disease, other specific etiologies, unknown etiology, incomplete workup) [ Time Frame: From day 0 to 24 months after inclusion ]
- Incidence of new SBI at 24 months (only if sufficient funding can be obtained for repeat brain MRI at 24 months without contrast agent) [ Time Frame: At 24 months ]
- Time to first diagnosis of AF (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hours) until battery depletion of Implantable Cardiac Monitor (ICM) (36-42 month). [ Time Frame: From day 0 until battery depletion, expected to be 36 to 42 months ]
- Cumulative incidence of AF diagnosis until battery depletion of ICM [ Time Frame: From day 0 to until battery depletion, expected to be 36 to 42 months ]
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): NCT04449523
|Contact: Laurent Roten, PD Dr. med.||+41 31 632 52 firstname.lastname@example.org|
|Contact: Thomas Meinel, Dr. med.||+41 76 49 28 email@example.com|
|Centre hospitalier universitaire vaudois (CHUV)|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Patrizio Pascale, PD Dr. med. firstname.lastname@example.org|
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Contact: Michael Kühne, Prof. email@example.com|
|Bern, Switzerland, 3010|
|Contact: Laurent Roten, PD Dr. med. firstname.lastname@example.org|
|Saint Gallen, Switzerland, 9007|
|Contact: Peter Ammann, Prof. email@example.com|
|Principal Investigator:||Laurent Roten, PD Dr. med.||Inselgruppe AG|