Key result
The CARDIOSTROKE trial protocol describes an ongoing randomized controlled trial to evaluate whether 3-week ECG monitoring and mobile-assisted blood pressure self-titration improves systolic blood pressure reduction and atrial fibrillation detection at 12 months compared to standard care.
Why the study?
Most patients with ischemic stroke or TIA fail to achieve desired blood pressure control, and AF remains underdiagnosed with standard ECG monitoring.
Does 3-week ECG monitoring combined with self-monitoring of BP and mobile-device-assisted self-titration of antihypertensives improve systolic BP reduction and detection of new AF in patients with recent ischemic stroke or TIA?
RCT (n=390)
Open-label
2:1 ratio
Yes
Does 3-week ECG monitoring combined with self-monitoring of BP and mobile-device-assisted self-titration of antihypertensives improve systolic BP reduction and detection of new AF in patients with recent ischemic stroke or TIA?
This protocol outlines a trial to evaluate whether mobile technology-assisted self-monitoring of blood pressure and prolonged ECG monitoring can improve risk factor control in patients with recent ischemic stroke or TIA.
BACKGROUND: Hypertension and atrial fibrillation (AF) are major treatable risk factors for ischemic stroke and transient ischemic attack (TIA). However, most of the patients with an ischemic stroke or TIA fail to reach desired blood pressure (BP) control and AF remains underdiagnosed with standard ECG monitoring. The aim of the CARDIOSTROKE study is to (1) test the effect of 3-week non-invasive ECG monitoring combined with (2) self-monitoring of BP and (3) patient-controlled titration of antihypertensives over 12 months in patients with recent non-cardioembolic ischemic stroke or TIA. METHODS: CARDIOSTROKE is an investigator-initiated, multicenter, open, prospective trial aiming to randomize patients with recent (within 1 month) ischemic stroke or TIA to receive in a 2:1 fashion either (1) standard diagnostic work-up and follow-up (control arm) or (2) 3-week ECG monitoring combined with self-monitoring of BP and mobile-device-assisted self-titration of antihypertensives (intervention arm). The co-primary outcomes are (1) mean reduction in systolic BP and (2) detection of new AF at 12 months. DISCUSSION: Mobile technology assisted control of the two major risk factors of stroke recurrence has not previously been studied in patients with recent stroke or TIA, which supports conducting a randomized trial in this patient population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03710902. Registered on October 16, 2018.
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Lumikari et al. (2025) conducted an RCT in Recent non-cardioembolic ischemic stroke or transient ischemic attack with hypertension (n=390). 3-week ECG monitoring combined with self-monitoring of BP and mobile-device-assisted self-titration of antihypertensives vs. Standard diagnostic work-up and follow-up was evaluated on Mean reduction in systolic blood pressure and detection of new atrial fibrillation at 12 months. The CARDIOSTROKE trial protocol describes an ongoing randomized controlled trial to evaluate whether 3-week ECG monitoring and mobile-assisted blood pressure self-titration improves systolic blood pressure reduction and atrial fibrillation detection at 12 months compared to standard care.
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