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

Jukka Putaala

Status: Enrolling

Conditions: Hypertension; Atrial Fibrillation; Ischemic Stroke; Transient Ischemic Attack; Empowerment

Treatments: Diagnostic Test: ECG monitoring for 3 weeks; Other: Self-monitoring of BP and self-titration of antihypertensive medication

Study type: Interventional

Funder types: Other

Identifiers

NCT03710902

HUS/53/2017

TYH2016127 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 405 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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405 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Self-monitoring of BP and self-titration of antihypertensive medication

Diagnostic Test: ECG monitoring for 3 weeks

Control

No Intervention group

Description:

Standard diagnostic work-up, follow-up, and treatment of hypertension.