BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

Study Overview
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Brief Summary
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The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.

Detailed Description
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Patients randomized to the BioMonitor arm will receive an implantable cardiac monitor (ICM; BioMonitor) with remote monitoring function (Home Monitoring®). If the device detects and reports an arrhythmia, patients will be appropriately examined and treated. Patients randomized to the control arm will receive best proven treatment, but no implantable cardiac monitor.

Official Title
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BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

Conditions
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Myocardial Infarction, Myocardial Infarction, Acute, Myocardial Infarction Old

Intervention / Treatment
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* Device: BioMonitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a history of MI according to guidelines CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women LVEF > 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment Patient accepts activation of Home Monitoring® Patient is able to understand the nature of the clinical study and has provided written informed consent Exclusion Criteria: Patients with hemorrhagic diathesis Permanent oral anticoagulation treatment for atrial fibrillation Indication for chronic renal dialysis Pacemaker or ICD implanted or indication for implantation Parkinson's disease Life expectancy < 1 year Participation in another interventional clinical Investigation Age < 18 years Woman who are pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BioMonitor arm<br>BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring) | Device: BioMonitor<br>* Patients will be implanted with the BioMonitor + Home Monitoring feature<br>|
| No Intervention: Control arm<br>Control group (standard of care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE) | The primary endpoint is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons as per study protocol. The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. All patients will be assessed for Time-to-Event Outcome Measures until formal study termination is announced or until the individual patient meets a drop out criterion in accordance with the study protocol. The study period is estimated 6 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause | The occurrence of death due to any cause will be recorded and analyzed. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation | Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation | Assessment of the time from randomization to cardiovascular death or heart transplantation during the clinical investigation. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit | Assessment of the time from randomization to first hospitalization or urgent visit for worsening of the patient status due to heart failure, or death due to heart failure. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization | Assessment of the time from randomization to the first hospitalization resulting from an arrhythmia or death resulting from arrhythmia. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization | Assessment of the time from randomization to the first hospitalization resulting from acute coronary syndrome or death resulting from acute coronary syndrome. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization | Assessment of the time from randomization to the first hospitalization resulting from stroke or death resulting from stroke. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization | Assessment of the time from randomization to the first hospitalization resulting from major bleeding or death resulting from major bleeding. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization | Assessment of the time from randomization to the first hospitalization resulting from systemic embolism or death resulting from systemic embolism. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement. | 2 years | 
| Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia | Assessment of the time from randomization to first arrhythmia. | 2 years | 
| Type of Initiated Therapies | Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias. | All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years. | 
| Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis | Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat. | 2 years | 
| Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months. | A further secondary endpoint is the assessment of the patient's well-being. The patient's well-being will be recorded during the regular telephone contacts using the WHO-5 Well-being Index. The scale reaches from 0 (worst status) to 100 (best possible status). | We report the intraindividual change from 6-months to 24-months. All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients. |