Myocardial InfarctionNCT03231826
Arrhythmias in Post-Myocardial Infarction Patients
An observational study of Myocardial Infarction and Coronary Artery Disease, run by Tampere University at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease, Arrythmia
- How many people
- 445 participants
- Where
- 1 siteFinland
- Study dates
- 22 Jun 2017to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Inclusion Criteria: Patients treated for myocardial infarction (NSTEMI and STEMI)
Exclusion Criteria: Short life expectancy, unwillingness to participate and need for permanent institutional care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Coronary Artery Disease, Arrythmia, ECG Electrical Alternans, Atrioventricular Block, Atrial Fibrillation
- Keywords
- Home monitoring, ECG, Myocardial Infarction, Arrythmia
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease, Arrhythmias, Cardiac, Atrioventricular Block, Atrial Fibrillation, Atrial Flutter, Tachycardia, Ventricular, Ventricular Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Mortality due to heart failure, complication of myocardial infarction, recurrent myocardial infarction, stroke or probable cardiac arrhythmia
Measured: One month and one year and five after myocardial infarction
Secondary outcomes (8)
Incident asymptomatic atrial fibrillation
Incidence of new-onset atrial fibrillation
Measured: Within two weeks after myocardial infarction
Incident ventricular arrhythmias
Ventricular tachycardias (NSVT and longer), ventricular fibrillation and Ventricular extrasystoles.
Measured: Within two weeks after myocardial infarction
Incident bradyarrhytmias
New bradyarrhytmias including AV block and sinus arrests.
Measured: Within two weeks after myocardial infarction
Rehospitalization
Rehospitalization due to any cause
Measured: One month and one year and five after myocardial infarction
Rehospitalization (CVD)
Rehospitalization due cardiovascular cause
Measured: 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
Measured: One month and one year and five after myocardial infarction
Incidence of symptomatic ventricular arrhythmias
Ventricular fibrillation, ventricular tachycardias and other ventricular arrhythmias medical
Measured: One month and one year and five after myocardial infarction
Overall mortality
Mortality due to any cause
Measured: One month and one year and five after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start22 Jun 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Tays Heart Hospital, GE Healthcare Finland Ltd, Fimlab Ltd, VTT Technical Research Centre of Finland, Bittium Ltd, The Finnish Funding Agency for Technology and Innovation, Politecnico Milano
- Responsible party
- Principal investigator, Jussi Hernesniemi, Tampere University
- Investigators
- Jussi A Hernesniemi, MD PhD, Principal investigator, Tays Heart Hospital and Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231826
- Sponsor's protocol ID
- R17023
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2017
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Arrhythmias After Hospital Discharge in Post-Myocardial Infarction Patients - the MADDEC Project
- ClinicalTrials.gov ID
- NCT03231826
- Acronym / sponsor ID
- R17023
- Conditions
- Myocardial Infarction, Coronary Artery Disease, Arrythmia, ECG Electrical Alternans, Atrioventricular Block, Atrial Fibrillation
- Keywords
- Home monitoring, ECG, Myocardial Infarction, Arrythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Tays Heart Hospital, GE Healthcare Finland Ltd, Fimlab Ltd, VTT Technical Research Centre of Finland, Bittium Ltd, The Finnish Funding Agency for Technology and Innovation, Politecnico Milano
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Incident asymptomatic atrial fibrillation
Time frame: Within two weeks after myocardial infarction
Incident ventricular arrhythmias
Time frame: Within two weeks after myocardial infarction
Incident bradyarrhytmias
Time frame: Within two weeks after myocardial infarction
Rehospitalization
Time frame: One month and one year and five after myocardial infarction
Rehospitalization (CVD)
Time frame: One month and one year and five after myocardial infarction
Incidence of symptomatic atrial arrhythmias
Time frame: One month and one year and five after myocardial infarction
Incidence of symptomatic ventricular arrhythmias
Time frame: One month and one year and five after myocardial infarction
Overall mortality
Time frame: One month and one year and five after myocardial infarction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Cohort description for MADDEC consortia study planLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jussi A Hernesniemi, MD PhD principal investigator
Tays Heart Hospital and Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Coronary Artery Disease, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: One month and one year and five after myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.