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NCT Number: NCT03710902

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

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG monitoring for 3 weeks

Diagnostic Test

A 3-week continuous ECG monitoring to detect occult AF.

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.

Primary outcomes

  1. Number of Participants with New Atrial fibrillation

    Time frame: 12 months

    New diagnosis of atrial fibrillation (>30 s)

  2. Change in Blood Pressure

    Time frame: 12 months

    Mean change in systolic/diastolic blood pressure

Secondary outcomes

  1. Number of Participants with New Cardiovascular Events within 12 Months

    Time frame: 12 months

    Any of stroke, myocardial infarction, revascularization, or cardiovascular death

  2. Number of Participants with New Cardiovascular Events within 36 Months

    Time frame: 36 months

    Any of stroke, myocardial infarction, revascularization, or cardiovascular death

  3. Health Care Costs

    Time frame: 36 months

    Total direct healthcare costs

Other outcomes

  1. Rate of Adverse Events

    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.

  2. Rate of Severe Adverse Events

    Time frame: 12 months

    Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Anu Eräkanto

CONTACT

[email protected]

Tuomas Lumikari, MD

CONTACT

[email protected]

+35894711

Sponsors and collaborators

Lead sponsor

Jukka Putaala

Other

Registry information

Acronym: CARDIOSTROKE

Important dates

Study start
2018
Primary completion
2026
Study completion
2028
First posted
Oct 18, 2018
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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