I63.4
Conditions
Interventions
Group 1: Patients with embolic stroke of unknown source
The study only includes non-invasive additional examinations. These include a standardised 12-lead ECG and transthoracic echocardiography with
Sponsors
St. Josef Hospital Bochum - Klinikum der Ruhr-Universität
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Patients with ESUS Inclusion criteria Diagnosis of ESUS: Imaging-confirmed non-lacunar ischemic cerebral infarction No =50% stenosis in an intra- or extracranial artery supplying the infarct territory No evidence of a major cardioembolic source (e.g., atrial fibrillation) No indication of other specific causes of stroke (e.g., arterial dissection, vasculitis) Sinus rhythm at the time of study inclusion Study inclusion within 30 days after the index event Age =18 years and 1 year Written informed consent for study participation 2) Patients with paroxysmal atrial fibrillation (clinically manifest AtCM) Inclusion criteria Confirmed diagnosis of paroxysmal atrial fibrillation according to ESC guidelines Sinus rhythm at the time of study-related examinations No prior stroke or transient ischemic attack (TIA) Planned or recently performed (=30 days) rhythm intervention (e.g., electrical cardioversion, pulmonary vein isolation) or elective cardiology consultation Age =18 years and 1 year Written informed consent for study participation 3) Control participants without manifest heart disease Inclusion criteria No known structural heart disease No atrial fibrillation or other clinically relevant cardiac arrhythmias No history of ischemic stroke or TIA Sinus rhythm at the time of study inclusion Age =18 years and 1 year Written informed consent for study participation
Exclusion criteria
Exclusion criteria: ESUS – Exclusion criteria Occurrence of atrial fibrillation before or during the index hospitalization Evidence of structural heart disease (e.g., severe valvular disease, severe left ventricular dysfunction <30%) Advanced renal failure (GFR <15 ml/min) Severe hepatic insufficiency Overt hyperthyroidism Prior heart valve replacement or coronary artery bypass graft (CABG) surgery Continuous pacemaker stimulation AtCM (paroxysmal atrial fibrillation group) – Exclusion criteria Persistent or long-standing atrial fibrillation without documented sinus rhythm Structural heart disease (e.g., severe valvular disease, severe left ventricular dysfunction <30%) Severe renal or hepatic insufficiency Overt hyperthyroidism Continuous pacemaker stimulation History of prior stroke or transient ischemic attack (TIA) Control group – Exclusion criteria Evidence of structural or functional heart disease Suspicion of previously undiagnosed arrhythmias (e.g., AV block, supraventricular tachycardia) History of stroke or TIA Severe renal or hepatic insufficiency Overt hyperthyroidism Continuous pacemaker stimulation General exclusion criteria (applicable to all groups) Age <18 or =90 years Life expectancy <1 year Inability to provide informed consent Refusal to participate in the study Participation in another clinical study with potential influence on the study endpoints
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint (clinical composite endpoint) Occurrence of any of the following events within 5 years of study enrollment: - Death (from any cause) - Ischemic stroke Annual follow-up as part of a structured telephone interview | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints a) Individual components of the primary endpoint - Death (from any cause) - Ischemic stroke - New-onset atrial fibrillation (ECG-based according to ESC criteria) | — |
Countries
Germany
Contacts
Public ContactMichael Gotzmann
St. Josef-Hospital Bochum - Klinikum der Ruhr-Universität
Outcome results
None listed