Key result
The BIO-GUARD-MI trial is an ongoing randomized controlled trial designed to evaluate whether early diagnosis and treatment of cardiac arrhythmias using an implantable cardiac monitor reduces MACE in post-myocardial infarction patients.
Why the study?
It was unknown whether early detection and treatment of cardiac arrhythmias using an implantable cardiac monitor can reduce major adverse cardiac events after myocardial infarction.
Does early detection and treatment of cardiac arrhythmias using an implantable cardiac monitor reduce major adverse cardiac events in high-risk postmyocardial infarction patients?
RCT (n=1,400)
Open-label
1:1 ratio, computer-generated sequence stratified for site and STEMI/NSTEMI
Yes
Does early detection and treatment of cardiac arrhythmias using an implantable cardiac monitor reduce major adverse cardiac events in high-risk postmyocardial infarction patients?
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The BIO-GUARD-MI study protocol describes a randomized trial to evaluate whether implantable cardiac monitors can reduce major adverse cardiac events in high-risk post-MI patients through early arrhythmia detection.
Background The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac devices means that physicians receive an early warning in cases of new-onset arrhythmias. While remote monitoring has been suggested to increase survival in heart failure patients with implantable defibrillators, trials using ICMs for continuous electrocardiographic monitoring of cardiac arrhythmias in the postmyocardial infarction setting have shown that patients who experienced cardiac arrhythmias such as atrial fibrillation, bradycardia, and ventricular tachyarrhythmia have an increased risk of major adverse cardiac events. Methods The Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction (BIO-GUARD-MI) study is designed to investigate and clarify whether the incidence of major adverse cardiac events can be decreased by early detection and treatment of cardiac arrhythmias using an ICM in patients after myocardial infarction. In addition, the study will allow us to describe the interplay between baseline characteristics, arrhythmias, and clinical events to improve the treatment of this high-risk patient population. The study will enroll and randomize a cohort of high-risk postmyocardial infarction patients with CHA 2 DS 2 -VASc score ≥ 4 and left ventricular ejection fraction > 35% to an ICM or conventional treatment. Physicians are provided with suggestions on how to respond to ICM-documented arrhythmias. An estimated 1400 patients will be enrolled and followed until 372 primary endpoints have occurred. In this paper, we describe the literature and rationale behind the design and interventions towards new-onset arrhythmias, as well as future perspectives and limitations for the use of ICMs. Discussion Remote monitoring may improve clinical outcome if it uncovers conditions with low symptom burden which cause or indicate an increased risk. A simple and easily implementable response to the information is important. Cardiac arrhythmias frequently start as asymptomatic, shorter lasting, and nightly events. The BIO-GUARD-MI trial represents the first attempt to simplify the response to the rather complex nature of heart arrhythmias. Trial registration Clinical Trials, NCT02341534 . Registered on 19 January 2015.
Jøns et al. (2019) conducted an RCT in Myocardial infarction (n=1,400). Implantable cardiac monitor (ICM) with automated daily remote monitoring vs. Conventional treatment was evaluated on Time from randomization to the first MACE (cardiovascular death, worsening heart failure requiring acute unscheduled hospitalization or urgent visit, or unscheduled cardiovascular hospitalization). The BIO-GUARD-MI trial is an ongoing randomized controlled trial designed to evaluate whether early diagnosis and treatment of cardiac arrhythmias using an implantable cardiac monitor reduces MACE in post-myocardial infarction patients.
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