Trials / Recruiting
RecruitingNCT03710902
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 405 (estimated)
- Sponsor
- Jukka Putaala · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-10-17
- Primary completion
- 2026-09-01
- Completion
- 2028-09-01
- First posted
- 2018-10-18
- Last updated
- 2025-03-20
Locations
4 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT03710902. Inclusion in this directory is not an endorsement.