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Completed

NCT Number: NCT03231826

Arrhythmias in Post-Myocardial Infarction Patients

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.

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Key information

About this study

Patients with acute myocardial infarction have exceptionally high mortality rates exceeding 10% during the first year post-MI. The incidence of sudden cardiac death after acute myocardial infarction is the same with ST-elevation and non-ST elevation myocardial infarction. The risk of disabling stroke and sudden cardiac death is high especially during the first months after myocardial infarction. Preventing these outcomes is of high priority, considering the fact that the quality of life can remain high in these patients, if serious adverse events can be avoided.

The high mortality and comorbidity rates among cardiac patients provide an opportunistic environment for testing the utility of of home monitoring by mobile devices, data integration and resulting mass data. Long follow-up times are not required, which facilitates the linking of potential risk factors with outcome.

The prospective part of the MADDEC (MAss Data in Detection and prevention of serious adverse Events in Cardiovascular disease) project aims at exploring mechanism of sudden death in the first month after a myocardial infarction and at detecting arrhythmias heralding life-threatening arrhythmias. Additionally, the project will define the incidence of new atrial fibrillation post myocardial infarction. The main outcomes of the study are all cause mortality, cardiovascular mortality, rehospitalization due to any or cardiovascular causes.

Prospective home monitoring of patients after ST-elevation or non-ST elevation myocardial infarction will commence in May 2017 and continue until the end of 2019. For arrhythmia detection, two different methods will be used: 12-channel Holter recording (GE Seer 12®, GE Healthcare Finland) and the eMotion Faros® device (Bittium Biosignals Ltd/Mega Elec-troncs Ltd, Finland). The aim is to record continuous 12-channel Holter data from 200-250 patients with ST-elevation myo-cardial infarction and 1-3 channel ECG signal data with the mobile Faros 360 device from 550-600 patients with any type of myocardial infarction. Exclusion criteria are short life expectancy, unwillingness to participate and need for permanent insti-tutional care. The first 24-48 hour recording will commence at hospital discharge or transferral to another health care unit. The second recording will take place two weeks after the index event. As a part of the protocol, the subjects will also perform simple tests measuring their functional status and possible disability at study enrollment. All accrued ECG-data will be inte-grated into a research database for further analysis, linking it with outcome data. The Faros 360 mobile device will also ena-ble recording patient activity, such as movement and respiratory rate, simultaneously using an accelerometer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients treated for myocardial infarction (NSTEMI and STEMI)

Exclusion criteria

Short life expectancy, unwillingness to participate and need for permanent institutional care

Treatment and study plan

Primary outcomes

  1. Cardiovascular mortality

    Time frame: One month and one year and five after myocardial infarction

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

Secondary outcomes

  1. Incident asymptomatic atrial fibrillation

    Time frame: Within two weeks after myocardial infarction

    Incidence of new-onset atrial fibrillation

  2. Incident ventricular arrhythmias

    Time frame: Within two weeks after myocardial infarction

    Ventricular tachycardias (NSVT and longer), ventricular fibrillation and Ventricular extrasystoles.

  3. Incident bradyarrhytmias

    Time frame: Within two weeks after myocardial infarction

    New bradyarrhytmias including AV block and sinus arrests.

  4. Rehospitalization

    Time frame: One month and one year and five after myocardial infarction

    Rehospitalization due to any cause

  5. Rehospitalization (CVD)

    Time frame: One month and one year and five after myocardial infarction

    Rehospitalization due cardiovascular cause

  6. Incidence of symptomatic atrial arrhythmias

    Time frame: One month and one year and five after myocardial infarction

    Atrial fibrillation, atrial flutter and other atrial arrhythmias leading to patient seeking medical attention and treatment

  7. Incidence of symptomatic ventricular arrhythmias

    Time frame: One month and one year and five after myocardial infarction

    Ventricular fibrillation, ventricular tachycardias and other ventricular arrhythmias medical

  8. Overall mortality

    Time frame: One month and one year and five after myocardial infarction

    Mortality due to any cause

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Bittium Ltd
  • Fimlab Ltd
  • GE Healthcare Finland Ltd
  • Politecnico Milano
  • Tays Heart Hospital
  • The Finnish Funding Agency for Technology and Innovation
  • VTT Technical Research Centre of Finland

Registry information

Official study title

Exploring Arrhythmias After Hospital Discharge in Post-Myocardial Infarction Patients - the MADDEC Project

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2017
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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