Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients with Ischemic Stroke (CARDIOSTROKE)

March 18, 2025 updated by: Jukka Putaala
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Diagnostic test: ECG monitoring for 3 weeks
A 3-week continuous ECG monitoring to detect occult AF.
Other: 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.
No Intervention: Control
Standard diagnostic work-up, follow-up, and treatment of hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with New Atrial fibrillation
Time Frame: 12 months
New diagnosis of atrial fibrillation (>30 s)
12 months
Change in Blood Pressure
Time Frame: 12 months
Mean change in systolic/diastolic blood pressure
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with New Cardiovascular Events within 12 Months
Time Frame: 12 months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
12 months
Number of Participants with New Cardiovascular Events within 36 Months
Time Frame: 36 months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
36 months
Health Care Costs
Time Frame: 36 months
Total direct healthcare costs
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jukka Putaala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2018

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/53/2017
  • TYH2016127 (Other Grant/Funding Number: Hospital District of Helsinki and Uusimaa)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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