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).

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.