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

Sponsor
Jukka Putaala (Other)
Overall Status
Recruiting
CT.gov ID
NCT03710902
Collaborator
(none)
405
5
2
109.5
81
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ECG monitoring for 3 weeks
  • Other: Self-monitoring of BP and self-titration of antihypertensive medication
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
405 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.
Primary Purpose:
Prevention
Official Title:
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Actual Study Start Date :
Oct 17, 2018
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with New Atrial fibrillation [12 months]

    New diagnosis of atrial fibrillation (>30 s)

  2. Change in Blood Pressure [12 months]

    Mean change in systolic/diastolic blood pressure

Secondary Outcome Measures

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

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

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

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

  3. Health Care Costs [36 months]

    Total direct healthcare costs

Other Outcome Measures

  1. Rate of Adverse Events [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 [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Hospital Helsinki Finland 00290
2 Hyvinkää Hospital Hyvinkää Finland
3 Kanta-Häme Central Hospital Hämeenlinna Finland
4 Päijät-Häme Central Hospital Lahti Finland
5 Lohja Hospital Lohja Finland

Sponsors and Collaborators

  • Jukka Putaala

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jukka Putaala, Head of Stroke Unit, Hospital District of Helsinki and Uusimaa
ClinicalTrials.gov Identifier:
NCT03710902
Other Study ID Numbers:
  • HUS/53/2017
  • TYH2016127
First Posted:
Oct 18, 2018
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2021