The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.
Atrial fibrillation (AF) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (TIA). Detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. Furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. In the CARDIOSTROKE trial, the investigators aim to randomize 405 patients with recent ischemic stroke or TIA into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ECG monitoring to detect occult AF and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). Randomization will occur 2:1 into control and intervention groups. The co-primary outcomes include (1) incidence of new-onset AF and (2) difference in the mean blood pressure at 12-months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
405
A 3-week continuous ECG monitoring to detect occult AF.
One-week monthly self-monitoring of BP and self-titration of antihypertensive medication according to a pre-specified protocol, assisted with a mobile device application.
Kanta-Häme Central Hospital
Hämeenlinna, Finland
RECRUITINGHelsinki University Hospital
Helsinki, Finland
RECRUITINGHyvinkää Hospital
Hyvinkää, Finland
RECRUITINGNumber of Participants with New Atrial fibrillation
New diagnosis of atrial fibrillation (\>30 s)
Time frame: 12 months
Change in Blood Pressure
Mean change in systolic/diastolic blood pressure
Time frame: 12 months
Number of Participants with New Cardiovascular Events within 12 Months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Time frame: 12 months
Number of Participants with New Cardiovascular Events within 36 Months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Time frame: 36 months
Health Care Costs
Total direct healthcare costs
Time frame: 36 months
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Päijät-Häme Central Hospital
Lahti, Finland
RECRUITING