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

NCT ID: NCT03710902

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-17

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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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

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Ischemic Stroke Transient Ischemic Attack Atrial Fibrillation Hypertension Empowerment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.

Study Groups

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Intervention

Group Type EXPERIMENTAL

ECG monitoring for 3 weeks

Intervention Type DIAGNOSTIC_TEST

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

Self-monitoring of BP and self-titration of antihypertensive medication

Intervention Type 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.

Control

Standard diagnostic work-up, follow-up, and treatment of hypertension.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ECG monitoring for 3 weeks

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jukka Putaala

OTHER

Sponsor Role lead

Responsible Party

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Jukka Putaala

Head of Stroke Unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kanta-Häme Central Hospital

Hämeenlinna, , Finland

Site Status RECRUITING

Helsinki University Hospital

Helsinki, , Finland

Site Status RECRUITING

Hyvinkää Hospital

Hyvinkää, , Finland

Site Status RECRUITING

Päijät-Häme Central Hospital

Lahti, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Tuomas Lumikari, MD

Role: CONTACT

+35894711

Anu Eräkanto

Role: CONTACT

Facility Contacts

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Tiina Alapirtti, MD, PhD

Role: primary

Elina Laakso, MD

Role: backup

Terhi Saarikoski, RN

Role: primary

+35894711

Terttu Heinkinheimo-Connell, MD, PhD

Role: primary

Katariina Hirvonen, MD

Role: backup

Tuomo Nieminen, MD, PhD, Prof.

Role: primary

Anne Kerola, MD, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40082922 (View on PubMed)

Other Identifiers

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TYH2016127

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUS/53/2017

Identifier Type: -

Identifier Source: org_study_id

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