NCT03231826

Brief Summary

Patients are screened for significant arrhythmias and other possibly significant ECG-patterns directly after discharge and two weeks after myocardial infarction using wearable devices. The home monitoring data will be linked with extensive data from electronic health records collected before, during hospital stay and after discharge. The purpose of the study is to clarify whether home monitoring of continuous ECG-signals can be used to predict and prevent serious adverse events after myocardial infarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 22, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

August 12, 2025

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

July 24, 2017

Last Update Submit

August 6, 2025

Conditions

Keywords

Home monitoringECGMyocardial InfarctionArrythmia

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality

    Mortality due to heart failure, complication of myocardial infarction, recurrent myocardial infarction, stroke or probable cardiac arrhythmia

    One month and one year and five after myocardial infarction

Secondary Outcomes (8)

  • Incident asymptomatic atrial fibrillation

    Within two weeks after myocardial infarction

  • Incident ventricular arrhythmias

    Within two weeks after myocardial infarction

  • Incident bradyarrhytmias

    Within two weeks after myocardial infarction

  • Rehospitalization

    One month and one year and five after myocardial infarction

  • Rehospitalization (CVD)

    One month and one year and five after myocardial infarction

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated at the study center (Tays Heart Hospital) between June 2017 and June 2019 fulfilling the eligibility criteria are invited to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tays Heart Hospital

Tampere, Pirkanmaa, 33540, Finland

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Recording of continuous ECG-signals

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery DiseaseArrhythmias, CardiacAtrioventricular BlockAtrial FibrillationAtrial FlutterTachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesHeart BlockCardiac Conduction System DiseaseTachycardia

Study Officials

  • Jussi A Hernesniemi, MD PhD

    Tays Heart Hospital and Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 27, 2017

Study Start

June 22, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

August 12, 2025

Record last verified: 2019-04

Locations