Background <p>In the Find-AF 2 randomised controlled trial, we investigate whether a risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation in ischaemic stroke patients leads to a reduction of recurrent ischaemic stroke and systemic embolism. The objective of this analysis is to present baseline characteristics of the overall Find-AF 2 study population and stratified by low or high risk for developing AF.</p> Methods <p>The Find-AF 2 trial included acute ischaemic stroke patients ≥ 60 years of age within 30 days of ischaemic stroke of any cause. Before randomisation, patients received a 24-h Holter-ECG to exclude those with easily detectable AF and to determine the presence or absence of enhanced supraventricular ectopic activity (ESVEA), used as a marker indicating high or low risk for developing AF. Those without AF were randomly assigned 1:1 to either usual care diagnostics for AF detection (control group) or enhanced, prolonged and intensified ECG monitoring (intervention group). In the intervention group, patients with ESVEA received an implantable cardiac monitor (ICM), whereas those without ESVEA received repeated annual 7-day Holter ECGs. We present baseline characteristics of the overall Find-AF 2 population and stratified by ESVEA.</p> Results <p>Between July 2020 and July 2024, 5227 patients (mean age 72.3 ± 7.5 years, 40% female, 2618 intervention group, 2609 control group) were randomised from 52 study centres in Germany within a median of 5 (IQR 3–7) days after the index stroke. The most frequent stroke aetiologies were cryptogenic (60%) and small vessel occlusion (19%). 1152 (22%) patients were at high risk for developing AF and 4075 (78%) at low risk. Patients within the high-risk stratum were significantly older (mean age 75.2 versus 71.5 years, <i>p</i> &lt; 0.001), more often had moderate to severe stroke (34% versus 30%, <i>p</i> &lt; 0.001), non-lacunar (70% versus 64%, <i>p</i> &lt; 0.001) and of cryptogenic aetiology (64% vs 58%, <i>p</i> &lt; 0.001).</p> Conclusions <p>The Find-AF 2 trial has successfully completed recruitment of a large acute ischaemic stroke population with different stroke subtypes. The follow-up is ongoing and results are expected within two years.</p> Trial registration <p>ClinicalTrials.gov, Identifier NCT04371055, registered 24 April 2020.</p>

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Baseline characteristics of patients with acute ischaemic stroke included in the randomised controlled Find-AF 2 trial

  • Katrin Wasser,
  • Tobias Uhe,
  • Wolf-Rüdiger Schäbitz,
  • Martin Köhrmann,
  • Martin Dichgans,
  • Johannes Brachmann,
  • Ulrich Laufs,
  • Götz Gelbrich,
  • David Petroff,
  • Christiane Prettin,
  • Dominik Michalski,
  • Johann Pelz,
  • Andrea Kraft,
  • Thorleif Etgen,
  • Hassan Soda,
  • Florian Bethke,
  • Peter D. Schellinger,
  • Katharina Althaus,
  • Gerhard F. Hamann,
  • Martin Grond,
  • Bernd Kallmünzer,
  • Martina Petersen,
  • Lars-Peder Pallesen,
  • Michael Ertl,
  • Philipp Zickler,
  • Sven Poli,
  • Karl Georg Haeusler,
  • Thorsten Steiner,
  • Paul Sparenberg,
  • Pawel Kermer,
  • Anna Kopczak,
  • Lars Kellert,
  • Martin Nückel,
  • Jan Liman,
  • Peter Arthur Ringleb,
  • Meinhard Mende,
  • Marcus Wagner,
  • Deborah Bochert,
  • Marlena Schnieder,
  • Imke Amanzada,
  • Sonja Gröschel,
  • Marianne Hahn,
  • Timo Uphaus,
  • Klaus Gröschel,
  • Rolf Wachter,
  • Katja Wartenberg,
  • Charlotte Huber,
  • Alhuda Dabbagh,
  • Matthias Kaste,
  • Ahmed Bouchair,
  • Ntalia Meleshchenco,
  • Sevinj Guluzade,
  • Christian Oelschläger,
  • Alkisti Kitsiou,
  • Julian Gehrmeyr,
  • Nikolaos Pantos,
  • Rebecca Seifert,
  • Matthias Korf,
  • Anne Beyer,
  • Christian Mahnkopf,
  • Steffen Schnupp,
  • Sonia Busch,
  • Thomas Mischke,
  • Nawar Alachkar,
  • Marianna Hahn,
  • Arda Civelek,
  • Khadija Mammadli,
  • Benedikt Frank,
  • Benjamin Stolte,
  • Jordi Kühne Escolá,
  • Stefan Kääb,
  • Konstantinos Dimitriadis,
  • Bettina Küster,
  • Moritz Sinner,
  • Maria Kaffe,
  • Philip Melton,
  • Janina Kuffer,
  • Jörg Berrouschot,
  • Anett Stoll,
  • Janina Keilitz,
  • Wiebke Keller,
  • Darius Nabavi,
  • Jens Offermann,
  • Olaf Crome,
  • Boris Dimitrijeski,
  • Carsten Meincke,
  • Gabor Petzold,
  • Felix Jürgen Bode,
  • Sebastian Stösser,
  • Julius Meißner,
  • Taraneh Ebrahimi,
  • Julia Nordsiek,
  • Niklas Beckonert,
  • Christian Thielscher,
  • Omid Shirvani,
  • Andreas Kastrup,
  • Andreas Schröter,
  • Jan Philip Jürß,
  • Volker Pütz,
  • Martin Arndt,
  • Timo Siepmann,
  • Mirko Brudzinski,
  • Frank R. Heinzel,
  • Jennifer Frehe,
  • Kosmala Macha,
  • Matthias Krämer,
  • Alexander Sektita,
  • Niklas Keller,
  • Jan Hedrik Schäfer,
  • Daniel Charisse,
  • Konstantin Kohlhase,
  • Ferdinand Bohmann,
  • Franziska Mayser,
  • Johanna Judith Herget,
  • Franziska Lieschke,
  • Luca Hladek,
  • Tobias Neumann-Haefelin,
  • Jörg Berthel,
  • Lirim Alijaj,
  • Anne Kandler,
  • Burkhard Alber,
  • Robert Müller,
  • Lars Marquardt,
  • Haiko Kazarians,
  • Karin Weissenborn,
  • Hans Worthmann,
  • Ann-Katrin Hennemann,
  • Johanna Ernst,
  • Svenja Jochmann,
  • Jana Al-Ayoubi,
  • Johannes Teller,
  • Ramona Schuppner,
  • Peter Ringleb,
  • Jan Purrucker,
  • Ioana Huber,
  • Simon Schieber,
  • Damjan Mirkov,
  • Carsten Hobohm,
  • Katrin Pomrehn,
  • Peter Schellinger,
  • Jörg Glahn,
  • Jan Schubert,
  • Simone Jenniges,
  • Jens Minnerup,
  • Renate Weinhardt,
  • Erich Hiermann,
  • Jan Birringer,
  • Sandra Lichte-Schneider,
  • Daniela Hütwohl,
  • Rainer Kollmar,
  • Ahmad Ajaz Ganai,
  • Jan Cierpinski,
  • Götz Thomalla,
  • Robert Schulz,
  • Focko Higgen,
  • Felix Nägele,
  • Joachim Röther,
  • Peter Michels,
  • Zoran Vukovic,
  • Robert Berger,
  • Jan Philip Buschmann,
  • Anna Alegiani,
  • Peter Cidlinsky,
  • Peter Nordbeck,
  • Dominik Lehrieder,
  • Thomas Fischer,
  • Christian Hametner,
  • Moritz Huttelmaier,
  • Simona Weiner,
  • Christine Vogl,
  • Stefanie Röckel,
  • Philipp Patrick Zickler,
  • Lino Braadt,
  • Michael Rosenkranz,
  • Stefan Boskamp,
  • Lena Selbel,
  • Christian Schöps,
  • Milena Haase,
  • Alexandra Gómez Expósito,
  • Joshua Mbro,
  • Julia Hummel,
  • Elena Buß,
  • Konstantin Kirchmeier,
  • Liubov Novikova,
  • Lars Udo Krause,
  • Lars Bobowski,
  • Hassan Abou Eid,
  • Esteban Vajda-Medina,
  • Mareike Probst,
  • Hisham Essa,
  • Bernhard Eberl,
  • Dragana Milankovic-Eberl,
  • Georg Rieder,
  • Olav Schwarte,
  • Constanze Höcherl,
  • Frank Hoffmann,
  • Bettina Schönmuth,
  • Anja Giebler,
  • Rafaela Voss,
  • Katrin Sachadae,
  • Oliver Bähr,
  • Herbert Gruber,
  • Sonka Benesch,
  • Thomas Pollinger,
  • Avinash Suntha,
  • Jana Fett,
  • Katja Burian,
  • Mirko Seidel,
  • Daniel Peters,
  • Stephan Lenze,
  • Judith Becher,
  • Katja Bahcesular,
  • Florans Pfeiffer,
  • Sophia Potthoff,
  • Mario Enrique de la Piedra Walter,
  • Bettina Schmitz,
  • Carolin Waldschmidt,
  • Anna Gutwinski,
  • Veronika Angermüller,
  • Tameem Alhammoud,
  • Hüsniye Cakiroglu,
  • Jörg Müller,
  • Martin Honermann,
  • Marian Christoph Burgstaller,
  • Herwig Strik,
  • Arne Lenz,
  • Mark Obermann,
  • Nicoletta Adochitei,
  • Frank Arne Wollenweber,
  • Laya Rahban,
  • Matthias Julius Grosch,
  • Erik Ellwardt,
  • Martin Jünemann,
  • Omar AlHaj Omar,
  • Christian Fräbel,
  • Toska Maxhuni,
  • Christian Claudi,
  • Oliver Posner,
  • Francesca Culay,
  • Waltraud Pfeilschifter,
  • Christoffer Kraemer,
  • Milena Wiemers,
  • Micha Simon,
  • Alexander Finke,
  • Ondrej Hlavac

摘要

Background

In the Find-AF 2 randomised controlled trial, we investigate whether a risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation in ischaemic stroke patients leads to a reduction of recurrent ischaemic stroke and systemic embolism. The objective of this analysis is to present baseline characteristics of the overall Find-AF 2 study population and stratified by low or high risk for developing AF.

Methods

The Find-AF 2 trial included acute ischaemic stroke patients ≥ 60 years of age within 30 days of ischaemic stroke of any cause. Before randomisation, patients received a 24-h Holter-ECG to exclude those with easily detectable AF and to determine the presence or absence of enhanced supraventricular ectopic activity (ESVEA), used as a marker indicating high or low risk for developing AF. Those without AF were randomly assigned 1:1 to either usual care diagnostics for AF detection (control group) or enhanced, prolonged and intensified ECG monitoring (intervention group). In the intervention group, patients with ESVEA received an implantable cardiac monitor (ICM), whereas those without ESVEA received repeated annual 7-day Holter ECGs. We present baseline characteristics of the overall Find-AF 2 population and stratified by ESVEA.

Results

Between July 2020 and July 2024, 5227 patients (mean age 72.3 ± 7.5 years, 40% female, 2618 intervention group, 2609 control group) were randomised from 52 study centres in Germany within a median of 5 (IQR 3–7) days after the index stroke. The most frequent stroke aetiologies were cryptogenic (60%) and small vessel occlusion (19%). 1152 (22%) patients were at high risk for developing AF and 4075 (78%) at low risk. Patients within the high-risk stratum were significantly older (mean age 75.2 versus 71.5 years, p < 0.001), more often had moderate to severe stroke (34% versus 30%, p < 0.001), non-lacunar (70% versus 64%, p < 0.001) and of cryptogenic aetiology (64% vs 58%, p < 0.001).

Conclusions

The Find-AF 2 trial has successfully completed recruitment of a large acute ischaemic stroke population with different stroke subtypes. The follow-up is ongoing and results are expected within two years.

Trial registration

ClinicalTrials.gov, Identifier NCT04371055, registered 24 April 2020.