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

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ECG monitoring for 3 weeks
Self-monitoring of BP and self-titration of antihypertensive medication
Sponsored by
Jukka Putaala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University HospitalRecruiting
  • Hyvinkää HospitalRecruiting
  • Kanta-Häme Central HospitalRecruiting
  • Päijät-Häme Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with New Atrial fibrillation
New diagnosis of atrial fibrillation (>30 s)
Change in Blood Pressure
Mean change in systolic/diastolic blood pressure

Secondary Outcome Measures

Number of Participants with New Cardiovascular Events within 12 Months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Number of Participants with New Cardiovascular Events within 36 Months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Health Care Costs
Total direct healthcare costs

Full Information

First Posted
October 16, 2018
Last Updated
April 5, 2023
Sponsor
Jukka Putaala
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1. Study Identification

Unique Protocol Identification Number
NCT03710902
Brief Title
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Acronym
CARDIOSTROKE
Official Title
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jukka Putaala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation, Hypertension, Empowerment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard diagnostic work-up, follow-up, and treatment of hypertension.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG monitoring for 3 weeks
Intervention Description
A 3-week continuous ECG monitoring to detect occult AF.
Intervention Type
Other
Intervention Name(s)
Self-monitoring of BP and self-titration of antihypertensive medication
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants with New Atrial fibrillation
Description
New diagnosis of atrial fibrillation (>30 s)
Time Frame
12 months
Title
Change in Blood Pressure
Description
Mean change in systolic/diastolic blood pressure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants with New Cardiovascular Events within 12 Months
Description
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Time Frame
12 months
Title
Number of Participants with New Cardiovascular Events within 36 Months
Description
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Time Frame
36 months
Title
Health Care Costs
Description
Total direct healthcare costs
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Rate of Adverse Events
Description
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
Title
Rate of Severe Adverse Events
Description
Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuomas Lumikari, MD
Phone
+35894711
Email
tuomas.lumikari@helsinki.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Anu Eräkanto
Email
anu.erakanto@hus.fi
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terhi Saarikoski, RN
Phone
+35894711
Email
terhi.saarikoski@hus.fi
First Name & Middle Initial & Last Name & Degree
Tuomo Nieminen, Prof.
First Name & Middle Initial & Last Name & Degree
Jukka Putaala, A/Prof.
First Name & Middle Initial & Last Name & Degree
Tuomas Lumikari, MD
Facility Name
Hyvinkää Hospital
City
Hyvinkää
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terttu Heinkinheimo-Connell, MD, PhD
Email
terttu.heikinheimo-connell@hus.fi
First Name & Middle Initial & Last Name & Degree
Katariina Hirvonen, MD
Email
katariina.hirvonen@hus.fi
Facility Name
Kanta-Häme Central Hospital
City
Hämeenlinna
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiina Alapirtti, MD, PhD
Email
tiina.alapirtti@khshp.fi
First Name & Middle Initial & Last Name & Degree
Elina Laakso, MD
Email
elina.laakso@khshp.fi
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuomo Nieminen, MD, PhD, Prof.
Email
tuomo.nieminen@gmail.com
First Name & Middle Initial & Last Name & Degree
Anne Kerola, MD, PhD
Email
anne.m.kerola@phhyky.fi

12. IPD Sharing Statement

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

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