Optimal Detection of Atrial Fibrillation in TIA

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    1434
  • sponsor
    Alfried Krupp Krankenhaus
Updated on 24 January 2021
electrocardiogram
stroke
holter monitor
infarct
fibrillation
brain infarction
electrocardiographic monitoring
cardiac monitoring
transient ischemic attack
paroxysmal atrial fibrillation
anticoagulation therapy
ecg monitoring

Summary

Transient ischemic attack (TIA) is a common neurologic emergency. Although the detection of atrial fibrillation (AF) has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. Despite these differences between stroke and TIA patients, previous studies have investigated diagnostic work-up for AF primarily in stroke patients. Thus, there is no common practice or "gold standard" of rhythm monitoring for TIA patients in most healthcare systems and the optimal method and duration of cardiac monitoring for TIA patients is currently unknown. This is likely to result in a substantial under-diagnosis of AF in TIA patients, failure to initiate appropriate secondary preventive medication (i.e. anticoagulation) and ultimately the occurrence of many otherwise preventable strokes.

The primary research question of the trial is whether prolonged ECG recording (intervention) significantly increases the rate of detection of paroxysmal AF compared to 24 h electrocardiogram (ECG) monitoring (control) 6 months after start of monitoring in patients with recent TIA. The co-primary question of the trial is whether 28 d non-invasive continuous ECG monitoring is non-inferior to ECG recording using an implanted event recorder for AF detection.

Description

Transient ischemic attacks (TIA) are a common neurologic emergency. Clinical management guidelines recommend oral anticoagulation for TIA patients suffering from atrial fibrillation (AF). Therefore, a diagnosis of AF in TIA patients has a major impact on the choice of adequate secondary stroke prevention. However, detection of paroxysmal AF in patients with TIA can be challenging. AF remains undetected in a relevant proportion of stroke and TIA patients using current routine diagnostic procedures. The actual prevalence of AF in TIA patients is unknown.

Although the detection of AF has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. So far, only limited data exist on AF detection after TIA specifically, and the best method for diagnosis of AF has not been established. The usefulness of prolonged rhythm monitoring using event recorders or non-invasive continuous ECG in TIA patients has not been determined. While the use of an AF detection tool in TIA patients is desirable, an adequate use of resources of AF detection technologies in unselected TIA patients may be needed for this large scale health care problem. Identifying TIA patients that are at increased risk of suffering from AF using clinical and blood-based biomarkers and therefore most likely to benefit from such diagnostic procedures would be useful.

The primary research question of the trial is whether prolonged ECG recording (intervention) significantly increases the rate of detection of pAF compared to 24 h ECG monitoring (control) 6 months after start of monitoring in patients with recent TIA. The co-primary question of the trial is whether 28 d non-invasive continuous ECG monitoring is non-inferior to ECG recording using an implanted event recorder for AF detection.

The ODEA-TIA trial is an investigator initiated prospective, multicentre, randomized, open study with blinded outcome assessment comparing different diagnostic methods for detection of paroxysmal AF in patients with recent TIA. The primary endpoint is the rate of AF detection during the 6 months after randomization. Approximately 40 centers in Europe (e.g. UK, Germany, and Spain) will participate in this trial. Patients with a recent TIA fulfilling the eligibility criteria (see below) will be randomized in a 1:1:1 fashion between 24 h arrhythmia monitoring (control arm) and the two procedures for prolonged ECG monitoring (interventional arms). That means we have two interventional arms, patients receiving either continuous 28d non-invasive ECG monitoring or ECG event recording using a subcutaneously implanted event recorder.

Details
Condition Arrhythmia, Atrial Fibrillation, Transient Ischemic Attack, Atrial Fibrillation (Pediatric), Dysrhythmia, transient ischemic attacks
Treatment 24-h Holter monitoring
Clinical Study IdentifierNCT04075500
SponsorAlfried Krupp Krankenhaus
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent by patient
Age 50 years
TIA diagnosed by a stroke physician defined as rapidly developing clinical signs of focal or global disturbances of cerebral function, lasting less than 24 hours with no apparent non-vascular cause and without evidence of recent brain infarction on available neuroimaging
-channel ECG available before enrolment
Brain imaging without acute infarct available before enrolment (CCT or cranial MRI)
Vascular imaging of cervical vessels performed

Exclusion Criteria

Previously documented history of AF
Ischemic stroke within the last 6 months before enrolment
Evidence of recent infarction on neuroimaging corresponding to symptoms at time of enrolment (e.g. DWI positive lesion on MRI scan)
Pre-screening monitoring for cardiac arrhythmias lasting 72 hours
AF lasting > 30 s on a 12 channel ECG or other ECG recording technique prior to enrolment
Life expectancy less than 1 year
Significant stenosis > 50% in intracranial or extracranial vessels which, in the opinion of the investigator, is the likely cause of the patients TIA
Severely disabled patients (i.e. modified Rankin Score >3)
Lack of therapeutic consequence in case of diagnosis of AF (e.g. other indication for long term anticoagulation
Pacemaker or Implanted Cardiac Defibrillator
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