Optimal Detection of Atrial Fibrillation in TIA

NCT04075500 | Completed DMC

• 1 other identifier: AKKNeuro2019July
• Study Type: interventional
• Target: 516
• Locations: 2 countries
• Sites: 27

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.

Conditions

Atrial Fibrillation; Transient Ischemic Attack

Keywords

atrial fibrillation; monitoring; ECG; ischemic attack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of AF in TIA patients as determined by prolongend ECG Monitoring techniques

  24 month

• Rate of newly detected AF at 12 and 24 month after study enrolment in patients with recent TIA

  12 and 24 month

Study Arms (3)

Arm 1

NO INTERVENTION

Control arm, 24-h Holter monitoring

Arm 2

OTHER

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

Device: Subcutaneously implanted event recorder (REVEAL LINQ)

Arm 3

OTHER

2nd interventional arm, 28-day continuous ECG monitoring

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

Interventions

Subcutaneously implanted event recorder (REVEAL LINQ) DEVICE

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

Arm 2

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

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

Arm 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• channel ECG available before enrolment
• Brain imaging available before enrolment (CCT or cranial MRI)
• Vascular imaging of cervical vessels performed

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfried Krupp Krankenhaus: lead
• Medtronic Bakken Research: collaborator
• Wuerzburg University Hospital: collaborator
• Coordinating Centre for Clinical Trials Heidelberg: collaborator

Study Sites (27)

Universitätsklinikum Aachen, Neurologie

Aachen, 52074, Germany

Location

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Carl-Thiem-Klinikum Cottbus; Klinik für Neurologie

Cottbus, 03048, Germany

Location

Klinikum Dortmund, Klinikzentrum Mitte / Neurologie

Dortmund, 44137, Germany

Location

Alfried Krupp Krankenhaus

Essen, 45131, Germany

Location

Universitätsmedizin Frankfurt; Klinik für Neurologie;

Frankfurt, 60590, Germany

Location

Bezirkskliniken Schwaben; Bezirkskrankenhaus Günzburg; Klinik für Neurologie

Günzburg, 89312, Germany

Location

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

Halle, 06120, Germany

Location

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

Halle, 06120, Germany

Location

Universitätsklinik Heidelberg, Neurologie

Heidelberg, 69120, Germany

Location

Universität Leipzig, Medizinische Fakultät; Klinik und Poliklinik für Neurologie

Leipzig, 04103, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

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

Tübingen, 72076, Germany

Location

RKU Universitäts- und Rehabilitationskliniken Ulm

Ulm, 89081, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario Torrecárdenas

Almería, 04009, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14011, Spain

Location

Hospital Dr. Josep Trueta

Girona, 17007, Spain

Location

Complejo Hospitalario Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41003, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Attack, Transient

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Roland Veltkamp, MD

  Initiator of study, leader PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: March 12, 2019
• Primary Completion: March 15, 2024
• Study Completion: August 31, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (16); ES (11)