Catch-up-ESUS - follow-up in embolic stroke of undetermined source (ESUS) in a prospective, open-label, observational study: study protocol and initial baseline data

Abstract

IntroductionSo far there is no uniform, commonly accepted diagnostic and therapeutic algorithm for patients with embolic stroke of undetermined source (ESUS). Recent clinical trials on secondary stroke prevention in ESUS did not support the use of oral anticoagulation. As ESUS comprises heterogeneous subgroups including a wide age-range, concomitant patent foramen ovale (PFO), and variable probability for atrial fibrillation (AF), an individualised approach is urgently needed. This prospective registry study aims to provide initial data towards an individual, structured diagnostic and therapeutic approach in ESUS patients.Methods and analysisThe open-label, investigator-initiated, prospective, single-centre, observational registry study (Catch-up-ESUS) started in 01/2018. Consecutive ESUS patients ≥18 years who give informed consent are included and will be followed up for 3 years. Stratified by age <60 or ≥60 years, the patients are processed following a standardised diagnostic and treatment algorithm with an interdisciplinary design involving neurologists and cardiologists. Depending on the strata, patients receive a transesophageal echocardiogram; all patients receive an implantable cardiac monitor. Patients <60 years with PFO and without evidence of concomitant AF are planned for PFO closure within 6 months after stroke. The current diagnostic and therapeutic workup of ESUS patients requires improvement by both standardisation and a more individualised approach. Catch-up-ESUS will provide important data with respect to AF detection and PFO closure and will estimate stratified stroke recurrence rates after ESUS.Ethics and disseminationThe study has been approved by the responsible ethics committee at the Ludwig Maximilian University, Munich, Germany (project number 17–685). Catch-Up-ESUS is conducted in accordance with the Declaration of Helsinki. All patients will have to give written informed consent or, if unable to give consent themselves, their legal guardian will have to provide written informed consent for their participation. The first observation period of the registry study is 1 year, followed by the first publication of the results including follow-up of the patients. Further publications will be considered according the predefined individual follow-up dates of the stroke patients up to 36 months.Trial registration numberClinicaltrialsregister.gov registry (NCT03820375).

Recurrent Stroke in a Young Patient with Embolic Stroke of Undetermined Source and Patent Foramen Ovale: Quo Vadis?

“…Therefore, ICM implantation before PFO closure should be considered. The diagnostic challenge and importance of new guideline recommendations is reflected by this case and the Catch-up-ESUS registry study [7]. In our Catch-up-ESUS registry study [7], a standardized search for AF is implemented for up to 6 months using ICM prior to an interventional PFO closure.…”

“…The diagnostic challenge and importance of new guideline recommendations is reflected by this case and the Catch-up-ESUS registry study [7]. In our Catch-up-ESUS registry study [7], a standardized search for AF is implemented for up to 6 months using ICM prior to an interventional PFO closure. Especially as PFO closure is invasive, possibly resulting in complications, an undesired closure may be avoided in patients with an indication for lifelong OAC.…”

“…1a). Diagnostic workup was performed according to our in-house treatment algorithm according to the Catch-up-ESUS registry (for further information on Catch-up-ESUS, see [7]). Catch-up-ESUS is an openlabel, academic, prospective, monocentric, observational registry study that started in January 2018.…”

“…Catch-up-ESUS is an openlabel, academic, prospective, monocentric, observational registry study that started in January 2018. Clinical data of all consecutive ESUS patients ≥18 years old treated in our hospital who have given written informed consent are collected and observed [7]. The treatment algorithm in Catch-up-ESUS includes ultrasound examination of the brain vessels, cardiac examination with ECG monitoring for at least 72 hours, transthoracic and transesophageal echocardiography, blood tests, and assessment of AF-related risk markers [7].…”

Prediction of atrial fibrillation in patients with embolic stroke of undetermined source

“…Since RESPECT-ESUS and NAVIGATE-ESUS trials failed in demonstrating superiority of DOAC over antiplatelets in ESUS patients, the detection of AF during follow-up continues to constitute the only clear indication for anticoagulation in this stroke population and as a result, an extended search for AF in ESUS patients continues to be essential, to maximize secondary prevention. However, yet, sustainable recommendations on both the modality and length of search for AF, as well as the selection of patients for screening, are missing(129).In the 2014 AHA/ASA Guidelines for the Prevention of Stroke in Patients With Stroke and TIA, there is weak evidence, for patients who have experienced an acute ischemic stroke or TIA with no other apparent cause, suggesting prolonged rhythm monitoring for AF for around 30 days within 6 months of the index event (Class of recommendation IIa; Level of Evidence C) (130). More recently, the 2019 AHA/ASA Guidelines for the Early Management of Patients With Acute Ischemic Stroke recommend cardiac monitoring for at least the first 24 hours after stroke onset (Class of recommendation I, level of Evidence B) but states that the effectiveness of prolonged cardiac monitoring during hospitalization after acute ischemic stroke, to guide treatment selection for prevention of recurrent stroke, is uncertain (Class of recommendation IIb, level of Evidence C) (131).…”