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

Hypertension Clinical Trial

— CARDIOSTROKE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03710902
• Other study ID #: HUS/53/2017
• Secondary ID: TYH2016127
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: December 2027

Study information

• Verified date: April 2023
• Source: Hospital District of Helsinki and Uusimaa
• Contact: Tuomas Lumikari, MD
• Phone: +35894711
• Email: tuomas.lumikari[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: December 2027
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Empowerment
• Hypertension
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Diagnostic Test:
• ECG monitoring for 3 weeks
A 3-week continuous ECG monitoring to detect occult AF.

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

Locations

Country	Name	City	State
Finland	Kanta-Häme Central Hospital	Hämeenlinna
Finland	Helsinki University Hospital	Helsinki
Finland	Hyvinkää Hospital	Hyvinkää
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (1)

Lead Sponsor	Collaborator
Jukka Putaala

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months
Other	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.	12 months
Primary	Number of Participants with New Atrial fibrillation	New diagnosis of atrial fibrillation (>30 s)	12 months
Primary	Change in Blood Pressure	Mean change in systolic/diastolic blood pressure	12 months
Secondary	Number of Participants with New Cardiovascular Events within 12 Months	Any of stroke, myocardial infarction, revascularization, or cardiovascular death	12 months
Secondary	Number of Participants with New Cardiovascular Events within 36 Months	Any of stroke, myocardial infarction, revascularization, or cardiovascular death	36 months
Secondary	Health Care Costs	Total direct healthcare costs	36 months