Optimal Detection of Atrial Fibrillation in TIA (ODEA-TIA)

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 using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Transient Ischemic Attack
• Intervention / Treatment: Device: Subcutaneously implanted event recorder (REVEAL LINQ); Device: 28-day non-invasive continuous ECG monitoring (patch)

Detailed 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 using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording. 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 (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
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, Neurologie
  • Bad Neustadt an der Saale, Germany, 97616
    • Rhön Klinikum Campus Bad Neustadt
  • Berlin, Germany, 12351
    • Vivantes Klinikum Neukölln
  • Cottbus, Germany, 03048
    • Carl-Thiem-Klinikum Cottbus; Klinik für Neurologie
  • Dortmund, Germany, 44137
    • Klinikum Dortmund, Klinikzentrum Mitte / Neurologie
  • Essen, Germany, 45131
    • Alfried Krupp Krankenhaus
  • Frankfurt, Germany, 60590
    • Universitätsmedizin Frankfurt; Klinik für Neurologie;
  • Günzburg, Germany, 89312
    • Bezirkskliniken Schwaben; Bezirkskrankenhaus Günzburg; Klinik für Neurologie
  • Halle, Germany, 06120
    • Krankenhaus Marth-Maria-Halle-Dölau GmbH; Klinik für Neurologie
  • Halle, Germany, 06120
    • Universitätsmedizin Halle; Universitätsklinikum Halle (Saale); Klinik und Poliklinik für Neurologie
  • Heidelberg, Germany, 69120
    • Universitätsklinik Heidelberg, Neurologie
  • Leipzig, Germany, 04103
    • Universität Leipzig, Medizinische Fakultät; Klinik und Poliklinik für Neurologie
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen; Neurologische Universitätsklinik; Abt. Neurologie mit Schwerpunkt vaskuläre Erkrankungen
  • Ulm, Germany, 89081
    • RKU Universitäts- und Rehabilitationskliniken Ulm
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Almería, Spain, 04009
    • Hospital Universitario Torrecárdenas
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Córdoba, Spain, 14011
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Hospital Dr. Josep Trueta
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Clinico Universitario de Santiago
  • Seville, Spain, 41009
    • Hospital Virgen Macarena
  • Seville, Spain, 41003
    • Hospital Universitario Virgen del Rocio
  • Bizkaia
    • Barakaldo, Bizkaia, Spain, 48903
      • Hospital Universitario de Cruces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 12-channel ECG available before enrolment
• Brain imaging available before enrolment (CCT or cranial MRI)
• Vascular imaging of cervical vessels performed
• Enrolment within 28 days after TIA episode. Exclusion Criteria
• Previously documented history of AF
• Ischemic stroke within the last 6 months before enrolment
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1; Control arm, 24-h Holter monitoring
Other: Arm 2; 1st interventional arm, subcutaneously implanted event recorder (REVEAL LINQ)	Device: Subcutaneously implanted event recorder (REVEAL LINQ); Patients receive a subcutaneously implantable cardiac device (REVEAL LINQ).
Other: Arm 3; 2nd interventional arm, 28-day continuous ECG monitoring	Device: 28-day non-invasive continuous ECG monitoring (patch); Patients receive a non-invasive continuous ECG monitoring (patch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of AF in TIA patients as determined by prolongend ECG Monitoring techniques	Self reported or by other means detected newly AF	24 month
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

Collaborators and Investigators

• Sponsor: Alfried Krupp Krankenhaus
• Collaborators: Wuerzburg University Hospital; Coordinating Centre for Clinical Trials Heidelberg; Medtronic Bakken Research
• Investigators: Principal Investigator: Roland Veltkamp, MD, Initiator of study, leader PI

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; ECG; monitoring; ischemic attack
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Brain Ischemia; Pathological Conditions, Signs and Symptoms; Ischemic Attack, Transient; Atrial Fibrillation; Equipment and Supplies; Transdermal Patch
• Other Study ID Numbers: AKKNeuro2019July

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No