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Trial record 32 of 38 for:    alternans

Arrhythmias in Post-Myocardial Infarction Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231826
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Tays Heart Hospital
GE Healthcare Finland Ltd
Fimlab Ltd
VTT Technical Research Centre of Finland
Bittium Ltd
Tekes - Finnish Funding Agency for Innovation
Politecnico Milano
Information provided by (Responsible Party):
Jussi Hernesniemi, Tampere University

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.


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

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.


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Study Type : Observational
Actual Enrollment : 445 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring Arrhythmias After Hospital Discharge in Post-Myocardial Infarction Patients - the MADDEC Project
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Recording of continuous ECG-signals


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231826


Locations
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Finland
Tays Heart Hospital
Tampere, Pirkanmaa, Finland, 33540
Sponsors and Collaborators
Tampere University
Tays Heart Hospital
GE Healthcare Finland Ltd
Fimlab Ltd
VTT Technical Research Centre of Finland
Bittium Ltd
Tekes - Finnish Funding Agency for Innovation
Politecnico Milano
Investigators
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Principal Investigator: Jussi A Hernesniemi, MD PhD Tays Heart Hospital and Tampere University

Additional Information:
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Responsible Party: Jussi Hernesniemi, Adjunct Professor, Tampere University
ClinicalTrials.gov Identifier: NCT03231826     History of Changes
Other Study ID Numbers: R17023
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jussi Hernesniemi, Tampere University:
Home monitoring
ECG
Myocardial Infarction
Arrythmia
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Myocardial Infarction
Tachycardia
Tachycardia, Ventricular
Atrial Flutter
Ventricular Fibrillation
Atrioventricular Block
Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiac Conduction System Disease
Heart Block