Actively Recruiting
Led by Jukka Putaala · Updated on 2025-03-20
405
Participants Needed
4
Research Sites
104 weeks
Total Duration
Researchers are evaluating the use of mobile-device assisted management of hypertension combined with screening for hidden atrial fibrillation in patients who recently experienced an ischemic stroke or transient ischemic attack (TIA). The trial aims to compare this approach to standard care in reducing cardiovascular risks. The study focuses on detecting atrial fibrillation, a key treatable risk factor, and improving blood pressure control, both important for preventing recurrent strokes. Participants are randomly assigned in a 2:1 ratio to either the standard diagnostic work-up and treatment group or an intervention group. The intervention involves 3 weeks of continuous ECG monitoring to detect hidden atrial fibrillation and monthly self-monitoring of blood pressure for one week with self-adjustment of blood pressure medications guided by a mobile device application. The control group receives usual follow-up and hypertension management without these additional technologies. During the 12-month study period, researchers will measure the incidence of new atrial fibrillation cases and changes in average blood pressure. Secondary outcomes include new cardiovascular events and healthcare costs up to 36 months. Participants will undergo regular assessments and follow-up to monitor these outcomes, with safety and adherence tracked throughout the study.
CONDITIONS
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants undergo standard diagnostic work-up and follow-up. Those in the intervention group also receive 3 weeks of continuous ECG monitoring to detect atrial fibrillation and perform one week of monthly self-monitoring of blood pressure with self-titration of antihypertensive medication using a mobile device.
Monthly visits for self-monitoring periods and periodic clinical visits as per study protocol
Duration - Up to 36 months
Participants are monitored for cardiovascular events and health outcomes after the treatment period, up to 36 months.
Periodic visits according to study follow-up schedule
Total: 4 locations
1
Kanta-Häme Central Hospital
Hämeenlinna, Finland
Actively Recruiting
2
Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
3
Hyvinkää Hospital
Hyvinkää, Finland
Actively Recruiting
4
Päijät-Häme Central Hospital
Lahti, Finland
Actively Recruiting
T
Tuomas Lumikari, MD
A
Anu Eräkanto
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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T Lumikari, J Putaala, J Pirinen...
https://pubmed.ncbi.nlm.nih.gov/40082922