Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke

Conditions
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Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation, Hypertension, Empowerment

Intervention / Treatment
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* Diagnostic Test: ECG monitoring for 3 weeks
* Other: Self-monitoring of BP and self-titration of antihypertensive medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Diagnostic Test: ECG monitoring for 3 weeks<br>* A 3-week continuous ECG monitoring to detect occult AF.<br>Other: Self-monitoring of BP and self-titration of antihypertensive medication<br>* 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.<br>|
| No Intervention: Control<br>Standard diagnostic work-up, follow-up, and treatment of hypertension. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with New Atrial fibrillation | New diagnosis of atrial fibrillation (>30 s) | 12 months | 
| Change in Blood Pressure | Mean change in systolic/diastolic blood pressure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with New Cardiovascular Events within 12 Months | Any of stroke, myocardial infarction, revascularization, or cardiovascular death | 12 months | 
| Number of Participants with New Cardiovascular Events within 36 Months | Any of stroke, myocardial infarction, revascularization, or cardiovascular death | 36 months | 
| Health Care Costs | Total direct healthcare costs | 36 months |