Clinical trial NCT03710902: Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Official title: Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Transient Ischemic Attack
Atrial Fibrillation
Hypertension
Empowerment
Lead sponsor: Hospital District of Helsinki and Uusimaa
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 405
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with New Atrial fibrillation
timeFrame: 12 months
measure: Change in Blood Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants with New Cardiovascular Events within 12 Months
timeFrame: 12 months
measure: Number of Participants with New Cardiovascular Events within 36 Months
timeFrame: 36 months
measure: Health Care Costs
timeFrame: 36 months
Other outcomes:
measure: Rate of Adverse Events
timeFrame: 12 months
measure: Rate of Severe Adverse Events
timeFrame: 12 months
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Hyvinkää
country: Finland
facility: Hyvinkää Hospital
city: Hämeenlinna
country: Finland
facility: Kanta-Häme Central Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
References: