Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions

NCT04449523 | Recruiting

• 1 other identifier: 2020-00227
• Study Type: observational
• Target: 150
• Locations: 3 countries
• Sites: 8

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.

Conditions

Silent Stroke; Silent Cerebral Infarct; Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  From day 0 to 24 months after inclusion

• Burden of AF

  From day 0 to 24 months after inclusion

• Time to composite of first diagnosis of AF, stroke and death.

  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.

  From day 0 to 24 months after inclusion

• Start of oral anticoagulation therapy at 24 months.

  At 24 months

Other Outcomes (2)

• 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).

  From day 0 until battery depletion, expected to be 36 to 42 months

• Cumulative incidence of AF diagnosis until battery depletion of ICM

  From day 0 to until battery depletion, expected to be 36 to 42 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

≥ 50 years

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (8)

Universitätsspital Graz

Graz, Austria

RECRUITING

Charite Berlin

Berlin, Germany

NOT YET RECRUITING

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Kantonsspital Aarau

Aarau, Switzerland

ACTIVE NOT RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Universitätsspital Zurich

Zurich, Switzerland

RECRUITING

Study Officials

• Laurent Roten, PD Dr. med.

  Inselgruppe AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Roten, PD Dr. med.

CONTACT

+41 31 632 52 63; laurent.roten@insel.ch

Thomas Meinel, Dr. med.

CONTACT

+41 76 49 28 545; thomas.meinel@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 29, 2020
• Study Start: September 8, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

AU (1); DE (1); CH (6)