Atrial Fibrillation, Empowerment, Hypertension, Ischemic Stroke, Transient Ischemic Attack
Conditions
Brief summary
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_TESTECG monitoring for 3 weeks
A 3-week continuous ECG monitoring to detect occult AF.
OTHERSelf-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.
Sponsors
Jukka Putaala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with New Atrial fibrillation | 12 months | New diagnosis of atrial fibrillation (\>30 s) |
| Change in Blood Pressure | 12 months | Mean change in systolic/diastolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Care Costs | 36 months | Total direct healthcare costs |
| Number of Participants with New Cardiovascular Events within 36 Months | 36 months | Any of stroke, myocardial infarction, revascularization, or cardiovascular death |
| Number of Participants with New Cardiovascular Events within 12 Months | 12 months | Any of stroke, myocardial infarction, revascularization, or cardiovascular death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events | 12 months | Adverse events related to ECG monitoring, blood pressure home monitoring, and mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol. |
| Rate of Severe Adverse Events | 12 months | Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol. |
Countries
Finland
Contacts
Primary ContactTuomas Lumikari, MD
Backup ContactAnu Eräkanto
Outcome results
None listed