Actively Recruiting

Age: 50Years +
All Genders
NCT04449523

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-14

150

Participants Needed

8

Research Sites

485 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Age 50 years or older with at least one of the following: NT-proBNP >400 pg/mL, left atrial ventricular index >42 ml/m2, left atrial diameter >46 mm, or covert infarctions involving more than one vascular territory
  • Signed written informed consent
  • Presence of any clinically silent ischemic brain lesions detected by neuroimaging meeting established criteria including diffusion weighted imaging positive lesions, cavitatory lesions ≥3 mm, or specific T2/T1 weighted MRI lesion characteristics
Not Eligible

You will not qualify if you...

  • History of atrial fibrillation or atrial flutter
  • History of symptoms compatible with acute ischemic stroke (covert neurological deficits allowed)
  • Presence of cardiac implantable electronic devices such as pacemaker, implantable cardiac defibrillator, or implantable cardiac monitor
  • Indication for implantation of cardiac implantable electronic devices
  • History of or indication for major cardiac surgery or transcutaneous aortic valve implantation
  • Indication for permanent oral anticoagulation
  • Contraindication for permanent oral anticoagulation
  • Life expectancy less than 2 years
  • Active high-grade intra- or extracranial malignancy
  • Participation in another clinical trial that affects this study's objectives
  • Lack of accountability or inability to understand the study implications
  • Inability to follow study procedures due to language, psychological disorders, dementia, or similar issues
  • Known or suspected non-compliance, drug or alcohol abuse

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Universitätsspital Graz

Graz, Austria

Actively Recruiting

2

Charite Berlin

Berlin, Germany

Not Yet Recruiting

3

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

4

Kantonsspital Aarau

Aarau, Switzerland

Active, Not Recruiting

5

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

6

Inselspital Bern

Bern, Switzerland, 3010

Actively Recruiting

7

Kantonsspital St.Gallen

Sankt Gallen, Switzerland, 9007

Actively Recruiting

8

Universitätsspital Zurich

Zurich, Switzerland

Actively Recruiting

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Research Team

L

Laurent Roten, PD Dr. med.

CONTACT

T

Thomas Meinel, Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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