Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack
Condition: Transient Ischemic Attack; Atrial Fibrillation
MeSH terms: Ischemic Attack, Transient; Atrial Fibrillation; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the frequency of atrial fibrillation in patients
      with transient ischemic attack (TIA). Patients suffering TIA will have their heart rhythm
      extensively monitored with 72-hour Holter-monitoring and an implantable loop-recorder.
      Furthermore, the patients will be examined with echocardiography, coronary calcium-score and
      biomarkers with the purpose to predict which subjects at risk for developing atrial
      fibrillation.
    

Detailed description: 
      Stroke is a leading cause of death and the survivors are often left with severe disability.
      Transient ischemic attack (TIA) is an episode of neurological dysfunction, but unlike stroke,
      the neurological deficits resolve completely within 24 hours. TIA and stroke share the same
      common underlying cause, and patients with a TIA are at high risk for developing a subsequent
      stroke. Atrial fibrillation (AF) is the most common cardiac arrhythmia and is recognized as
      the cause of around 25% of all strokes. The prevalence of AF rises with age, and it is
      estimated, that approximately 5-10% of all subjects over the age of 80 years has either
      persistent or paroxysmal AF. Regardless of the AF subtype the risk for stroke is the same,
      and oral anticoagulation therapy is recognized as a superior treatment of AF related
      stroke/TIA.

      The goal of this project is to extend the normal workup of patients with TIA with a thorough
      heart monitoring program. This includes 72-hours ambulatory electrocardiogram and insertion
      of an implantable loop recorder (ILR). The ILR is small device implanted in the subcutaneous
      tissue in the left thoracic region. The device continuously monitors for arrhythmias in a
      period up to 3 years. The 150 patients enrolled will also receive an ultrasound examination
      of the heart and arteries of the neck and a computed tomography scan of the heart. Lastly,
      biomarkers with known or suspected association with stroke and AF will be measured.

      The primary goal of the study is to determine, whether or not an extended heart monitoring
      program with an ILR will identify more patients with AF as the underlying cause of TIA. This
      can have enormous advantages for the patient, because the treatment with oral anticoagulation
      therapy reduces the risk of subsequent stroke by approximately 40% compared to conventional
      antiplatelet therapy. Secondly, the study means to identify patients at high risk for
      developing AF assessed with ultrasound, computed tomography and novel biomarkers.
    

Intervention name(s): Implantable loop-recorder
Intervention type(s): Device
Intervention description(s): All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.
Other intervention name(s): Reveal XT, Medtronic Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Transient Ischemic Attack; Atrial Fibrillation; NOTICE; Implantable loop-recorder; Holter-monitoring