CARDIOSTROKE: Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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.
|
No Intervention: Control Standard diagnostic work-up, follow-up, and treatment of hypertension. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- Rate of Adverse Events [12 months]
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.
- Rate of Severe Adverse Events [12 months]
Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Helsinki University Hospital | Helsinki | Finland | 00290 | |
2 | Hyvinkää Hospital | Hyvinkää | Finland | ||
3 | Kanta-Häme Central Hospital | Hämeenlinna | Finland | ||
4 | Päijät-Häme Central Hospital | Lahti | Finland | ||
5 | Lohja Hospital | Lohja | Finland |
Sponsors and Collaborators
- Jukka Putaala
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUS/53/2017
- TYH2016127