ECG monitoring for 3 weeks
Diagnostic TestA 3-week continuous ECG monitoring to detect occult AF.
NCT Number: NCT03710902
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Helsinki University Hospital, Helsinki, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 3-week continuous ECG monitoring to detect occult AF.
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.
Time frame: 12 months
New diagnosis of atrial fibrillation (>30 s)
Time frame: 12 months
Mean change in systolic/diastolic blood pressure
Time frame: 12 months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Time frame: 36 months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Time frame: 36 months
Total direct healthcare costs
Time frame: 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.
Time frame: 12 months
Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.
Contact information is provided by the study sponsor or research team.
Jukka Putaala
Other
Acronym: CARDIOSTROKE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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