Atrial Fibrillation Clinical Trial
Official title:
Optimal Detection of Atrial Fibrillation in Transient Ischemic Attack
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.
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.
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