The AF SPICE trial is a protocol designed to evaluate whether extended ECG monitoring reduces stroke, all-cause mortality, and intracerebral bleeding compared to standard monitoring.
RCT (n=3,262)
1:1
Yes
Does extended ECG monitoring reduce the composite of stroke, all-cause mortality, and intracerebral bleeding in elderly patients with ischemic stroke or TIA compared to standard ECG monitoring?
The AF SPICE trial protocol outlines a randomized study to determine if extended ECG monitoring improves hard clinical outcomes compared to standard monitoring in elderly patients following an ischemic stroke or TIA.
INTRODUCTION: Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity. METHODS AND ANALYSIS: AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24-72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023-2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up. ETHICS AND DISSEMINATION: Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021-02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice. TRIAL REGISTRATION NUMBER: NCT05134454.
Engdahl et al. (2023) conducted an RCT in Ischaemic stroke or transient ischaemic attack (n=3,262). Extended ECG monitoring vs. Standard ECG monitoring (48±24 hours of continuous ECG monitoring) was evaluated on Composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. The AF SPICE trial is a protocol designed to evaluate whether extended ECG monitoring reduces stroke, all-cause mortality, and intracerebral bleeding compared to standard monitoring.