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

ConditionsIschemic Stroke Transient Ischemic Attack Atrial Fibrillation Hypertension Empowerment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorJukka Putaala

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known high-risk source of cardioembolism

Known indication for anticoagulation

Contraindication for anticoagulation

Pacemaker

Trial design

Design model

Parallel

Treatments tested in this trial

ECG monitoring for 3 weeks
Diagnostic test
A 3-week continuous ECG monitoring to detect occult AF.
Self-monitoring of BP and self-titration of antihypertensive medication
Other intervention
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.

Treatment groups

405 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 2 interventions

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number 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

Secondary outcomes

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

Other outcomes

Rate of Adverse Events

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.

Time frame

12 months

Rate of Severe Adverse Events

Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.

Time frame

12 months