Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECG monitoring for 3 weeks, Self-monitoring of BP and self-titration of antihypertensive medication.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation, Hypertension. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Diagnostic test ECG monitoring for 3 weeks
A 3-week continuous ECG monitoring to detect occult AF. - Other Self-monitoring of BP and self-titration of antihypertensive medication
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.
Primary outcome measures
- Number of Participants with New Atrial fibrillation [Time frame: 12 months]
- Change in Blood Pressure [Time frame: 12 months]
Secondary outcome measures (3)
- Number of Participants with New Cardiovascular Events within 12 Months [Time frame: 12 months]
- Number of Participants with New Cardiovascular Events within 36 Months [Time frame: 36 months]
- Health Care Costs [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Ischemic stroke or transient ischemic attack (ABCD2 score ≥3)
- Age ≥40 years
- Pre-existing or newly diagnosed hypertension
- Informed consent from the patient or legal representative
Exclusion criteria
- Known high-risk source of cardioembolism
- Known indication for anticoagulation
- Contraindication for anticoagulation
- Pacemaker
- Non-compliance to study interventions as judged by the investigator
- Serious condition hampering the study conduct
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Finland · 4 centers
- Kanta-Häme Central Hospital — Hämeenlinna
- Helsinki University Hospital — Helsinki
- Hyvinkää Hospital — Hyvinkää
- Päijät-Häme Central Hospital — Lahti
Publications
- Lumikari T, Putaala J, Pirinen J, Kerola A, Sibolt G, Granroth-Wilding H, Pakarinen S, Lehto M, Nieminen T. 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). Trials. 2025 Mar 14;26(1):89. doi: 10.1186/s13063-025-0 PMID 40082922
Identifiers
NCT: NCT03710902 · HUS/53/2017 · TYH2016127