Optimal Detection of Atrial Fibrillation in TIA (ODEA-TIA)
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|ClinicalTrials.gov Identifier: NCT04075500|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : February 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Transient Ischemic Attack||Device: 24-h Holter monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1434 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patient will be randomized to either receive 24-h Holter Monitoring or receive one of the two modes for prolonged ECG recording (interventional arms). Patient will either undergo 28-day ECG recording using a commercially available Holter Recorder that can function as a non-invasive ECG patch or receive an implantable cardiac device (REVEAL LINQ).|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Optimal Detection of Atrial Fibrillation in Transient Ischemic Attack|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
No Intervention: Arm 1
Control arm, 24-h Holter monitoring
Interventional arms, prolonged cardiac monitoring
Device: 24-h Holter monitoring
Patients will be randomized to either receive 24-h Holter monitoring or receive one of the two modes for prolonged ECG recording (interventional arms). There are two interventional arms. Patients will either undergo 28-day ECG recording using a commercially available Holter recorder that can function as a non-invasive ECG patch or receive an implantable cardiac device (REVEAL LINQ).
- Rate of newly detected AF at 6 month after study enrolment in patients with recent TIA [ Time Frame: 6 month ]Self reported or by other means detected newly AF
- Prevalence of AF in TIA patients as determined by prolongend ECG Monitoring techniques [ Time Frame: 24 month ]Self reported or by other means detected newly AF
- Rate of newly detected AF at 12 and 24 month after study enrolment in patients with recent TIA [ Time Frame: 12 and 24 month ]Self reported or by other means detected newly AF in longterm ECG Monitoring
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075500
|Contact: Roland Veltkamp, MD||+49-201-434-41410||Roland.firstname.lastname@example.org|
|Contact: Birgit Lyss||+49-201-434-41418||Birgit.Lyss@krupp-krankenhaus.de|
|Universitätsklinikum Aachen, Neurologie||Not yet recruiting|
|Aachen, Germany, 52074|
|Contact: Johannes Schiefer, MD +49-241-8089630|
|Sub-Investigator: Johannes Schiefer, MD|
|Rhön Klinikum Campus Bad Neustadt||Not yet recruiting|
|Bad Neustadt An Der Saale, Germany, 97616|
|Contact: Hassan Soda, MD +49-9771-90800-9771|
|Sub-Investigator: Hassan Soda, MD|
|Vivantes Klinikum Neukölln||Not yet recruiting|
|Berlin, Germany, 12351|
|Contact: Darius Nabawi, MD +49-30-130-142023|
|Sub-Investigator: Darius Nabawi, MD|
|Klinikum Dortmund, Klinikzentrum Mitte / Neurologie||Recruiting|
|Dortmund, Germany, 44137|
|Contact: Gernot Reimann, MD +49-231-953-0|
|Sub-Investigator: Gernot Reimann, MD|
|Alfried Krupp Krankenhaus||Recruiting|
|Essen, Germany, 45131|
|Contact: Roland Veltkamp, MD +49-201-434-41410 Roland.Veltkamp@krupp-krankenhaus.de|
|Principal Investigator: Roland Veltkamp, MD|
|Universitätsklinik Heidelberg, Neurologie||Not yet recruiting|
|Heidelberg, Germany, 69120|
|Contact: Jan Purrucker, MD +46-6221-567504|
|Sub-Investigator: Jan Purrucker, MD|
|Universitätsklinikum Schleswig-Holstein, Campus Lübeck||Not yet recruiting|
|Lübeck, Germany, 23538|
|Contact: Georg Royl, MD +49-451-5000|
|Sub-Investigator: Georg Royl, MD|
|Principal Investigator:||Roland Veltkamp, MD||Initiator of study, leader PI|