Optimal Detection of Atrial Fibrillation in TIA

NCT ID: NCT04075500

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2025-08-31

Brief 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 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.

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.

Conditions

Atrial Fibrillation; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Control arm, 24-h Holter monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2

1st interventional arm, subcutaneously implanted event recorder (REVEAL LINQ)

Group Type: OTHER

Subcutaneously implanted event recorder (REVEAL LINQ)

Intervention Type: DEVICE

Patients receive a subcutaneously implantable cardiac device (REVEAL LINQ).

Arm 3

2nd interventional arm, 28-day continuous ECG monitoring

Group Type: OTHER

28-day non-invasive continuous ECG monitoring (patch)

Intervention Type: DEVICE

Patients receive a non-invasive continuous ECG monitoring (patch)

Interventions

Subcutaneously implanted event recorder (REVEAL LINQ)

Patients receive a subcutaneously implantable cardiac device (REVEAL LINQ).

Intervention Type: DEVICE

28-day non-invasive continuous ECG monitoring (patch)

Patients receive a non-invasive continuous ECG monitoring (patch)

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Bakken Research

INDUSTRY

Sponsor Role: collaborator

Coordinating Centre for Clinical Trials Heidelberg

UNKNOWN

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: collaborator

Alfried Krupp Krankenhaus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland Veltkamp, MD

Role: PRINCIPAL_INVESTIGATOR

Initiator of study, leader PI

Locations

Universitätsklinikum Aachen, Neurologie

Aachen, , Germany

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Carl-Thiem-Klinikum Cottbus; Klinik für Neurologie

Cottbus, , Germany

Klinikum Dortmund, Klinikzentrum Mitte / Neurologie

Dortmund, , Germany

Alfried Krupp Krankenhaus

Essen, , Germany

Universitätsmedizin Frankfurt; Klinik für Neurologie;

Frankfurt, , Germany

Bezirkskliniken Schwaben; Bezirkskrankenhaus Günzburg; Klinik für Neurologie

Günzburg, , Germany

Krankenhaus Marth-Maria-Halle-Dölau GmbH; Klinik für Neurologie

Halle, , Germany

Universitätsmedizin Halle; Universitätsklinikum Halle (Saale); Klinik und Poliklinik für Neurologie

Halle, , Germany

Universitätsklinik Heidelberg, Neurologie

Heidelberg, , Germany

Universität Leipzig, Medizinische Fakultät; Klinik und Poliklinik für Neurologie

Leipzig, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Universitätsklinikum Tübingen; Neurologische Universitätsklinik; Abt. Neurologie mit Schwerpunkt vaskuläre Erkrankungen

Tübingen, , Germany

RKU Universitäts- und Rehabilitationskliniken Ulm

Ulm, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Hospital Universitario Torrecárdenas

Almería, , Spain

Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Dr. Josep Trueta

Girona, , Spain

Complejo Hospitalario Clinico Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Virgen Macarena

Seville, , Spain

Countries

Germany; Spain

Other Identifiers

AKKNeuro2019July

Identifier Type: -

Identifier Source: org_study_id