Arrhythmias in Post-Myocardial Infarction Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease; Atrial Fibrillation; Ventricular Fibrillation; Ventricular Tachycardia; Atrioventricular Block; Atrial Flutter; Ventricular Arrythmia; Arrythmia; ECG Electrical Alternans

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.

• Study Type: Observational
• Enrollment (Actual): 445

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33540
      • Tays Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria: Patients treated for myocardial infarction (NSTEMI and STEMI)

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident asymptomatic atrial fibrillation	Incidence of new-onset atrial fibrillation	Within two weeks after myocardial infarction
Incident ventricular arrhythmias	Ventricular tachycardias (NSVT and longer), ventricular fibrillation and Ventricular extrasystoles.	Within two weeks after myocardial infarction
Incident bradyarrhytmias	New bradyarrhytmias including AV block and sinus arrests.	Within two weeks after myocardial infarction
Rehospitalization	Rehospitalization due to any cause	One month and one year and five after myocardial infarction
Rehospitalization (CVD)	Rehospitalization due cardiovascular cause	One month and one year and five after myocardial infarction
Incidence of symptomatic atrial arrhythmias	Atrial fibrillation, atrial flutter and other atrial arrhythmias leading to patient seeking medical attention and treatment	One month and one year and five after myocardial infarction
Incidence of symptomatic ventricular arrhythmias	Ventricular fibrillation, ventricular tachycardias and other ventricular arrhythmias medical	One month and one year and five after myocardial infarction
Overall mortality	Mortality due to any cause	One month and one year and five after myocardial infarction

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: VTT Technical Research Centre of Finland; Tays Heart Hospital; GE Healthcare Finland Ltd; Fimlab Ltd; Bittium Ltd; Tekes - Finnish Funding Agency for Innovation; Politecnico Milano
• Investigators: Principal Investigator: Jussi A Hernesniemi, MD PhD, TAYS Heart Hospital and Tampere University

Publications and helpful links

Helpful Links

• Cohort description for MADDEC consortia study plan

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Myocardial Infarction; ECG; Home monitoring; Arrythmia
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Heart Block; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Atrioventricular Block; Atrial Fibrillation; Coronary Artery Disease; Myocardial Infarction; Infarction; Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Atrial Flutter; Ventricular Fibrillation
• Other Study ID Numbers: R17023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The use of the collected data is primarily only available to the members of the research consortia but may be made available for collaborators with restrictions and only fully anonymized and pending the approval from the owners of the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No