Skip to content

Arrhythmias in Post-Myocardial Infarction Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03231826
Enrollment
445
Registered
2017-07-27
Start date
2017-06-22
Completion date
2019-02-28
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia, Atrial Fibrillation, Atrial Flutter, Atrioventricular Block, Coronary Artery Disease, ECG Electrical Alternans, Myocardial Infarction, Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia

Keywords

Home monitoring, ECG, Myocardial Infarction, Arrythmia

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.

Detailed description

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.

Interventions

None listed

Sponsors

Tays Heart Hospital
CollaboratorUNKNOWN
GE Healthcare Finland Ltd
CollaboratorUNKNOWN
Fimlab Ltd
CollaboratorUNKNOWN
VTT Technical Research Centre of Finland
CollaboratorOTHER
Bittium Ltd
CollaboratorUNKNOWN
Tekes - Finnish Funding Agency for Innovation
CollaboratorUNKNOWN
Politecnico Milano
CollaboratorUNKNOWN
Tampere University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patients treated for myocardial infarction (NSTEMI and STEMI)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular mortalityOne month and one year and five after myocardial infarctionMortality due to heart failure, complication of myocardial infarction, recurrent myocardial infarction, stroke or probable cardiac arrhythmia

Secondary

MeasureTime frameDescription
Incident ventricular arrhythmiasWithin two weeks after myocardial infarctionVentricular tachycardias (NSVT and longer), ventricular fibrillation and Ventricular extrasystoles.
Incident bradyarrhytmiasWithin two weeks after myocardial infarctionNew bradyarrhytmias including AV block and sinus arrests.
RehospitalizationOne month and one year and five after myocardial infarctionRehospitalization due to any cause
Incident asymptomatic atrial fibrillationWithin two weeks after myocardial infarctionIncidence of new-onset atrial fibrillation
Incidence of symptomatic atrial arrhythmiasOne month and one year and five after myocardial infarctionAtrial fibrillation, atrial flutter and other atrial arrhythmias leading to patient seeking medical attention and treatment
Incidence of symptomatic ventricular arrhythmiasOne month and one year and five after myocardial infarctionVentricular fibrillation, ventricular tachycardias and other ventricular arrhythmias medical
Overall mortalityOne month and one year and five after myocardial infarctionMortality due to any cause
Rehospitalization (CVD)One month and one year and five after myocardial infarctionRehospitalization due cardiovascular cause

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026