NCT04075500Completed
Optimal Detection of Atrial Fibrillation in TIA
Optimal Detection of Atrial Fibrillation in Transient Ischemic Attack
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 516 (actual)
- First submitted
- 28 Aug 2019
- Start date
- 12 Mar 2019
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Alfried Krupp Krankenhaus
- Diseases
- Atrial fibrillation
- NCT number
- NCT04075500
What you commit to
- Study type: Interventional
- Participants enrolled: 516
- From 12 Mar 2019 to the primary completion date, 15 Mar 2024
- 27 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Criteria the registry did not label
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Aachen, Neurologie Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| RHÖN-KLINIKUM Campus Bad Neustadt Coordinator of this site? Confirm its status | Bad Neustadt an der Saale | Germany | Unknown status |
| Vivantes Klinikum Neukölln Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Carl-Thiem-Klinikum Cottbus; Klinik für Neurologie Coordinator of this site? Confirm its status | Cottbus | Germany | Unknown status |
| Klinikum Dortmund, Klinikzentrum Mitte / Neurologie Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Alfried Krupp Krankenhaus Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsmedizin Frankfurt; Klinik für Neurologie; Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Bezirkskliniken Schwaben; Bezirkskrankenhaus Günzburg; Klinik für Neurologie Coordinator of this site? Confirm its status | Günzburg | Germany | Unknown status |
| Krankenhaus Marth-Maria-Halle-Dölau GmbH; Klinik für Neurologie Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsmedizin Halle; Universitätsklinikum Halle (Saale); Klinik und Poliklinik für Neurologie Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsklinik Heidelberg, Neurologie Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universität Leipzig, Medizinische Fakultät; Klinik und Poliklinik für Neurologie Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitatsklinikum Schleswig-Holstein - Campus Lubeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Universitätsklinikum Tübingen; Neurologische Universitätsklinik; Abt. Neurologie mit Schwerpunkt vaskuläre Erkrankungen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| RKU Universitäts- und Rehabilitationskliniken Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Dr. Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Complejo Hospitalario Clinico Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.