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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
802
Patients will be implanted with the BioMonitor + Home Monitoring feature
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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Gateway Cardiology
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Altru Health System
Grand Forks, North Dakota, United States
Abington Medical Specialists
Abington, Pennsylvania, United States
Carolina Heart Specialists
Lancaster, South Carolina, United States
Carolina Cardiology Associates
Rock Hill, South Carolina, United States
Metro Knoxville HMA LLC
Knoxville, Tennessee, United States
Lyell McEwin Hospital (LMH)
Elizabeth Vale, South Australia, Australia
East Metropolitan Health Service Trading AS Royal Perth HOSPITAL
Perth, Western Australia, Australia
...and 49 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia
Assessment of the time from randomization to first arrhythmia.
Time frame: 2 years
Type of Initiated Therapies
Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.
Time frame: 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.
Time frame: 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).
Time frame: 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.