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

Not Applicable

Recruiting

• Conditions: Transient Ischemic Attack; Empowerment; Ischemic Stroke; Atrial Fibrillation; Hypertension
• Interventions: Diagnostic Test: ECG monitoring for 3 weeks; Other: Self-monitoring of BP and self-titration of antihypertensive medication

• Registration Number: NCT03710902
• Lead Sponsor: Jukka Putaala

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.

Study Timeline

• Study First Submitted: 2018-10-16
• Study Start: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 405

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	ECG monitoring for 3 weeks	-
Intervention	Self-monitoring of BP and self-titration of antihypertensive medication	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants with New Cardiovascular Events within 12 Months	12 months	Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Number of Participants with New Cardiovascular Events within 36 Months	36 months	Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Health Care Costs	36 months	Total direct healthcare costs

Trial Locations

Locations (4)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Hyvinkää Hospital; 🇫🇮 Hyvinkää, Finland

Kanta-Häme Central Hospital; 🇫🇮 Hämeenlinna, Finland

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Finland