Atrial Fibrillation Clinical Trial
— ODEA-TIAOfficial 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.
Status | Recruiting |
Enrollment | 1434 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Eligibility Criteria: Study Population Patients with a recent TIA will be enrolled during a period of approximately 24 months at participating European stroke centres. TIA patients may be enrolled after initial management as inpatients or outpatients. Consecutive screening and enrolment will be strongly encouraged and a screening log will be implemented at each site. 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. - 12-channel ECG available before enrolment - Brain imaging without acute infarct available before enrolment (CCT or cranial MRI) - Vascular imaging of cervical vessels performed - Enrolment within 28 days after index episode. 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Aachen, Neurologie | Aachen | |
Germany | Rhön Klinikum Campus Bad Neustadt | Bad Neustadt An Der Saale | |
Germany | Vivantes Klinikum Neukölln | Berlin | |
Germany | Klinikum Dortmund, Klinikzentrum Mitte / Neurologie | Dortmund | |
Germany | Alfried Krupp Krankenhaus | Essen | |
Germany | Universitätsklinik Heidelberg, Neurologie | Heidelberg | |
Germany | Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck |
Lead Sponsor | Collaborator |
---|---|
Alfried Krupp Krankenhaus |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of newly detected AF at 6 month after study enrolment in patients with recent TIA | Self reported or by other means detected newly AF | 6 month | |
Secondary | Prevalence of AF in TIA patients as determined by prolongend ECG Monitoring techniques | Self reported or by other means detected newly AF | 24 month | |
Secondary | Rate of newly detected AF at 12 and 24 month after study enrolment in patients with recent TIA | Self reported or by other means detected newly AF in longterm ECG Monitoring | 12 and 24 month |
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