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| ID | Type | Description | Link |
|---|---|---|---|
| TYH2016127 | Other Grant/Funding Number | Hospital District of Helsinki and Uusimaa |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | No Intervention | Standard diagnostic work-up, follow-up, and treatment of hypertension. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG monitoring for 3 weeks | Diagnostic Test | A 3-week continuous ECG monitoring to detect occult AF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with New Atrial fibrillation | New diagnosis of atrial fibrillation (>30 s) | 12 months |
| Change in Blood Pressure | Mean change in systolic/diastolic blood pressure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with New Cardiovascular Events within 12 Months | Any of stroke, myocardial infarction, revascularization, or cardiovascular death | 12 months |
| Number of Participants with New Cardiovascular Events within 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of Severe Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuomas Lumikari, MD | Contact | +35894711 | tuomas.lumikari@helsinki.fi | |
| Anu Eräkanto | Contact | anu.erakanto@hus.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanta-Häme Central Hospital | Recruiting | Hämeenlinna | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082922 | Derived | Lumikari T, Putaala J, Pirinen J, Kerola A, Sibolt G, Granroth-Wilding H, Pakarinen S, Lehto M, Nieminen T. Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE). Trials. 2025 Mar 14;26(1):89. doi: 10.1186/s13063-025-08778-x. |
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Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.
| Self-monitoring of BP and self-titration of antihypertensive medication | Other | 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. |
|
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
| 36 months |
| Health Care Costs | Total direct healthcare costs | 36 months |
Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.
| 12 months |
| Helsinki University Hospital | Recruiting | Helsinki | 00290 | Finland |
|
| Hyvinkää Hospital | Recruiting | Hyvinkää | Finland |
|
| Päijät-Häme Central Hospital | Recruiting | Lahti | Finland |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
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