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. 2025 Mar 14;26(1):89.
doi: 10.1186/s13063-025-08778-x.

Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE)

T Lumikari  1 , J Putaala  2 , J Pirinen  3 , A Kerola  4   5 , G Sibolt  2 , Hanna Granroth-Wilding  6 , S Pakarinen  7 , M Lehto  7 , T Nieminen  5
Affiliations

Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE)

T Lumikari et al. Trials. .

Abstract

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.

Keywords: Atrial fibrillation; Blood pressure; Electrocardiogram; Empowerment; Hypertension; Ischemic stroke; Mobile technology; Transient ischemic attack.

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Conflict of interest statement

Ethics approval and consent to participate: Ethics approval was obtained from the Ethics Committee of the Hospital District of Helsinki and Uusimaa. All authors have been approved to conduct research in the trial. Written informed consent will be signed by each participant who is included in the trial. Consent for publication: Not applicable. Competing interests: Authors have no competing interests to declare. Trial funder has no role in trial planning, data collection, or data analysis.

Figures

Fig. 1
Fig. 1
Study flow
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments during the trial according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). TIA, transient ischemic attack; BP, blood pressure; ECG, electrocardiogram
See this image and copyright information in PMC

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