Silent StrokeSILENT2NCT04449523
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
An observational study of Silent Stroke and Silent Cerebral Infarct, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Silent Stroke, Silent Cerebral Infarct, Fibrillation
- How many people
- 150 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 8 Sep 2020to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ≥ 50 years
Who may be able to join
- Age
- ≥ 65 years
- ≥ 50 years AND one the following:
- NT-proBNP >400 pg/mL
- Left atrial ventricular index >42 ml/m2 or left atrial diameter >46 mm
- Covert infarctions with cortical involvement in more than one vascular territory (left carotid territory, right carotid territory, vertebrobasilar territory)
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- Written informed Consent
- Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established criteria as either:
- Diffusion weighted imaging (DWI) positive lesions: Focus of restricted diffusion (high DWI signal and low apparent diffusion coefficient value) occurring in either white or gray matter, located in the cerebrum, cerebellum, or brain stem AND not satisfying the diagnostic criteria for multiple sclerosis OR
- Cavitatory Lesions: ≥ 3 mm in size that follow cerebro-spinal fluid on all sequences that are slit or wedge shaped with an irregular margin AND NOT longitudinally aligned with perforating vessels or with a multiple, bilateral symmetrical distribution OR
- T2 weighted (T2W) hyperintense/T1 weighted (T1W) hypointense lesions:
- Focal lesion with high T2W signal and low T1W signal that have prior evidence of restricted diffusion; OR
- Present within cortical gray matter or deep gray matter nuclei OR
- A lesion that is new, compared with an MRI performed within 3 months OR
- T2W hyper/T1W hypointense lesions in the white matter, which are discontinuous but associated with the classic confluent periventricular T2 intense change of leukoaraiosis (Fazekas ≥2) AND NOT satisfying the diagnostic criteria for multiple sclerosis or with a significant patient history of severe trauma, radiation, drug toxicity, or carbon monoxide poisoning
Who cannot join
- History of AF or atrial flutter
- Patients with a history of symptoms compatible with an AIS, covert neurological deficits are allowed.
- Cardiac implantable electronic devices (pacemaker, implantable cardiac defibrillator (ICD), implantable cardiac monitor (ICM))
- Indication for cardiac implantable electronic device implantation (pacemaker, ICD, ICM)
- History of or indication for major cardiac surgery or transcutaneous aortic valve implantation
- Indication for permanent oral anticoagulation
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- Contraindication for permanent oral anticoagulation
- Projected life expectancy of less than 2 years
- Active intra- or extracranial high-grade malignancy
- Patient is already included in another clinical trial that will affect the objectives of this study
- Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Known or suspected non-compliance, drug or alcohol abuse
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
Switzerland6 sites, 5 recruiting
- Active, not recruiting
Kantonsspital Aarau
Aarau
- Recruiting
University Hospital Basel
Basel, 4031
Michael Kühne, Prof., michael.kuehne@usb.ch
- Recruiting
Inselspital Bern
Bern, 3010
Laurent Roten, PD Dr. med., laurent.roten@insel.ch
- Recruiting
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Patrizio Pascale, PD Dr. med., patrizio.pascale@chuv.ch
- Recruiting
Kantonsspital St.Gallen
Sankt Gallen, 9007
Peter Ammann, Prof., peter.ammann@kssg.ch
- Recruiting
Universitätsspital Zurich
Zurich
Susanne Wegener, Prof, Susanne.Wegener@usz.ch
Austria1 site, 1 recruiting
- Recruiting
Universitätsspital Graz
Graz
Markus Kneihsl, MD PhD, markus.kneihsl@medunigraz.at
Germany1 site, 1 recruiting
- Not yet recruiting
Charite Berlin
Berlin
Christian Nolte, Prof, christian.nolte@charite.de
About this study
Official title: Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)
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.
Read the 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; 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.
- Conditions
- Silent Stroke, Silent Cerebral Infarct, Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of Arterial Fibrillation (AF) diagnosis over a median of 24 months
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.
Measured: From day 0 to 24 months after inclusion
Secondary outcomes (9)
Time to first diagnosis of AF (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hour)
Measured: From day 0 to 24 months after inclusion
Burden of AF
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.
Measured: From day 0 to 24 months after inclusion
Time to composite of first diagnosis of AF, stroke and death.
Measured: 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.
Embolic stroke of undetermined source (ESUS)
Measured: From day 0 to 24 months after inclusion
Start of oral anticoagulation therapy at 24 months.
Measured: At 24 months
Stroke at 24 months
Measured: At 24 months
Mortality at 24 months
Measured: 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)
Measured: 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)
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start8 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent StrokeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Roten, PD Dr. med., Principal investigator, Inselgruppe AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449523
- Sponsor's protocol ID
- 2020-00227
- Acronym
- SILENT2
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)
- ClinicalTrials.gov ID
- NCT04449523
- Acronym / sponsor ID
- SILENT2 / 2020-00227
- Conditions
- Silent Stroke, Silent Cerebral Infarct, Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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; 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ≥ 50 years
Key inclusion criteria (15 listed)
- Age
- Written informed Consent
- Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established criteria as either:
Key exclusion criteria (13 listed)
- History of AF or atrial flutter
- Patients with a history of symptoms compatible with an AIS, covert neurological deficits are allowed.
- Cardiac implantable electronic devices (pacemaker, implantable cardiac defibrillator (ICD), implantable cardiac monitor (ICM))
- Indication for cardiac implantable electronic device implantation (pacemaker, ICD, ICM)
- History of or indication for major cardiac surgery or transcutaneous aortic valve implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Roten, PD Dr. med. principal investigator
Inselgruppe AG
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silent Stroke and Silent Cerebral Infarct, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Roten, PD Dr. med. (+41 31 632 52 63, laurent.roten@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of Arterial Fibrillation (AF) diagnosis over a median of 24 months (time frame: From day 0 to 24 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.