Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (MonDAFIS): a randomised, open-label, multicentre study

Hæusler, Karl Georg; Kirchhof, Paulus; Kunze, Claudia; Tütüncü, Serdar; Fießler, Cornelia; Malsch, Carolin; Olma, Manuel C.; Jawad-Ul-Qamar, Muhammad; Kramer, Michael D.; Wachter, Rolf; Michalski, Dominik; Kraft, Andrea; Rizos, Timolaos; Gröschel, Klaus; Thomalla, Götz; Nabavi, Darius G.; Röther, Joachim; Laufs, Ulrich; Veltkamp, Roland; Heuschmann, Peter U.; Endres, Matthias; Bauerle, Michael; Besselmann, Michael; Büttner, Thomas; Dem, Petra; Diekmann, Jens; Dietzel, Joanna; Dziewas, Rainer; Ehrlich, Steve; Evens, Annette; Gahn, Georg; Günther, Albrecht; Hamann, Gerhard F.; Hartmann, Andreas; Harvey, K. L.; Heidenreich, Fedor; Helberg, T; Hobohm, Carsten; Hoffmann, Franz-Josef; Hoffmann, Olaf; Jungehülsing, Gerhard Jan; Kampschulte, Eva-Maria; Kraft, Peter; Krogias, Christos; Leinisch, Elke; Maschke, Matthias; Merkelbach, S.; Muehler, Johannes; Niehaus, L.; Nören, Gesa; Oschmann, Patrick; Palm, Frederick; Petzold, Gabor C.; Pfeiler, Larissa; Pfeilschifter, Waltraud; Prince, Marie; Ringleb, Peter A.; Rosenkranz, Michael; Royl, Georg; Schnabel, Renate B.; Schurig, Johannes; Steinbrecher, Andreas; Stingele, Robert; Tanislav, Christian; Tyler, Louise; Urbanek, Christian

doi:10.1016/s1474-4422(21)00067-3

Cited by 55 publications

(56 citation statements)

References 16 publications

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“…For the later reason, we excluded an RCT evaluating an in-hospital cardiac rhythm monitoring intervention with an intent for up to 7 days Holter-ECG recording, but with actual recording time of 24-72 hours in 22.3% of the patients, and more than 120 hours in only 50.4% of the patients allocated to the intervention arm. 18 unpublished data on stroke recurrence, which were not reported in the original study publications. Study and patient characteristics are briefly summarized in Table 1 and eTable 2.…”

Section: Resultsmentioning

confidence: 99%

Prolonged Cardiac Monitoring and Stroke Recurrence

et al. 2022

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Background and ObjectivesProlonged poststroke cardiac rhythm monitoring (PCM) reveals a substantial proportion of patients with ischemic stroke (IS) with atrial fibrillation (AF) not detected by conventional rhythm monitoring strategies. We evaluated the association between PCM and the institution of stroke preventive strategies and stroke recurrence.MethodsWe searched MEDLINE and SCOPUS databases to identify studies reporting stroke recurrence rates in patients with history of recent IS or TIA receiving PCM compared with patients receiving conventional cardiac rhythm monitoring. Pairwise meta-analyses were performed under the random effects model. To explore for differences between the monitoring strategies, we combined direct and indirect evidence for any given pair of monitoring devices assessed within a randomized controlled trial (RCT).ResultsWe included 8 studies (5 RCTs, 3 observational; 2,994 patients). Patients receiving PCM after their index event had a higher rate of AF detection and anticoagulant initiation in RCTs (risk ratio [RR] 3.91, 95% CI 2.54–6.03; RR 2.16, 95% CI 1.66–2.80, respectively) and observational studies (RR 2.06, 95% CI 1.57–2.70; RR 2.01, 95% CI 1.43–2.83, respectively). PCM was associated with a lower risk of recurrent stroke during follow-up in observational studies (RR 0.29, 95% CI 0.15–0.59), but not in RCTs (RR 0.72, 95% CI 0.49–1.07). In indirect analyses of RCTs, the likelihood of AF detection and anticoagulation initiation was higher for implantable loop recorders compared with Holter monitors and external loop recorders.DiscussionPCM after an IS or TIA can lead to higher rates of AF detection and anticoagulant initiation. There is no solid RCT evidence supporting that PCM may be associated with lower stroke recurrence risk.

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Section: Resultsmentioning

confidence: 99%

Prolonged Cardiac Monitoring and Stroke Recurrence

et al. 2022

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“…Overall, these recent randomized clinical trials confirmed that PCM is associated with increased AF detection, 1–5 even among patients with strokes caused by atherothrombotic and atheroembolic mechanisms (small and large artery disease). 3 Whether AF detected after noncardioembolic events is associated with the same embolic risk as AF diagnosed in patients with cryptogenic strokes, remains unknown.…”

Section: Pcm Poststrokementioning

confidence: 76%

“…Three in patients with ischemic stroke and 3 in patients with and without a previous cerebrovascular event (Table). 1–3 MonDAFIS (Monitoring for Detection of Atrial Fibrillation in Ischemic Stroke) compared 7 days of inhospital Holter monitoring versus usual care in patients with unselected (cryptogenic and noncryptogenic) ischemic stroke or transient ischemic attack (TIA). 1 The study showed no differences between groups in the primary end point of the proportion of patients receiving anticoagulants at 12 months.…”

Section: Pcm Poststrokementioning

confidence: 99%

“…1–3 MonDAFIS (Monitoring for Detection of Atrial Fibrillation in Ischemic Stroke) compared 7 days of inhospital Holter monitoring versus usual care in patients with unselected (cryptogenic and noncryptogenic) ischemic stroke or transient ischemic attack (TIA). 1 The study showed no differences between groups in the primary end point of the proportion of patients receiving anticoagulants at 12 months. 1 There were no differences in AF diagnostic rates or the risk of recurrent stroke at 12 months either (Table).…”

Section: Pcm Poststrokementioning

confidence: 99%

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Advances in Neurocardiology: Focus on Atrial Fibrillation

Sposato

Gurol

2021

Stroke

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“…Then, there have been limitations to extensive long-term ECG monitoring. Moreover, a recently published large study showed that 7 days of monitoring was not long enough to make a significant difference compared to conventional strategies (standard vs. 7-day Holter until discharge in the stroke unit, 4.0% vs. 5.8%; total n = 3 465) ( 32 ).…”

Section: Discussionmentioning

confidence: 99%

Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale

Jung

Lee

Kang

et al. 2022

Front. Cardiovasc. Med.

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BackgroundAlthough many electrocardiography wearable devices have been released recently for the detection of atrial fibrillation (AF), there are few studies reporting prospective data for wearable devices compared to the strategy of the existing guidelines in the detection of atrial fibrillation (AF) after cryptogenic stroke. A tiny single-patch monitor is more convenient than a conventional Holter monitor recording device and, therefore, longer duration of monitoring may be acceptable.Methods and DesignThe CANDLE-AF study is a multicenter, prospective, randomized controlled trial. Patients with transient ischemic attack or ischemic stroke without any history of AF will be enrolled. The superiority of the 72-h single-patch monitor to standard strategy and non-inferiority of the 72-h single-patch monitor to an event-recorder-type device will be investigated. Single-patch monitor arm will repeat monitoring at 1, 3, 6, and 12 months, event-recorder-type arm will repeat monitoring twice daily for 12 months. The enrollment goal is a total of 600 patients, and the primary outcome is the detection of AF which continues at least 30 s during study period. The secondary outcome is the rate of changes from antiplatelet to anticoagulant and major adverse cardiac and cerebrovascular events within 1 year.ConclusionsThe results of CANDLE-AF will clarify the role of a single-lead patch ECG for the early detection of AF in patients with acute ischemic stroke. In addition, the secondary outcome will be analyzed to determine whether more sensitive AF detection can affect the prognosis and if further device development is meaningful. (cris.nih.go.kr KCT0005592).

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Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (MonDAFIS): a randomised, open-label, multicentre study

Cited by 55 publications

References 16 publications

Prolonged Cardiac Monitoring and Stroke Recurrence

Prolonged Cardiac Monitoring and Stroke Recurrence

Advances in Neurocardiology: Focus on Atrial Fibrillation

Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale

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