NCT03710902

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2018Sep 2028

First Submitted

Initial submission to the registry

October 16, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

7.9 years

First QC Date

October 16, 2018

Last Update Submit

March 18, 2025

Conditions

Ischemic StrokeTransient Ischemic AttackAtrial FibrillationHypertensionEmpowerment

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • Number of Participants with New Cardiovascular Events within 12 Months

    12 months

  • Number of Participants with New Cardiovascular Events within 36 Months

    36 months

  • Health Care Costs

    36 months

Other Outcomes (2)

  • Rate of Adverse Events

    12 months

  • Rate of Severe Adverse Events

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL
Diagnostic Test: ECG monitoring for 3 weeksOther: Self-monitoring of BP and self-titration of antihypertensive medication

Control

NO INTERVENTION

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

Interventions

ECG monitoring for 3 weeksDIAGNOSTIC_TEST

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

Intervention
Self-monitoring of BP and self-titration of antihypertensive medicationOTHER

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kanta-Häme Central Hospital

Hämeenlinna, Finland

RECRUITING

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Hyvinkää Hospital

Hyvinkää, Finland

RECRUITING

Päijät-Häme Central Hospital

Lahti, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40082922DERIVED

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, TransientAtrial FibrillationHypertensionEmpowerment

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Central Study Contacts

Tuomas Lumikari, MD

CONTACT

+35894711tuomas.lumikari@helsinki.fi

Anu Eräkanto

CONTACT

anu.erakanto@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Stroke Unit

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 18, 2018

Study Start

October 17, 2018

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

FI(4)